Calcium Gluconate and Magnesium Sulfate in Preventing Neurotoxicity in Patients With Colon Cancer or Rectal Cancer Receiving Oxaliplatin-Based Combination Chemotherapy

Sponsor

Alliance for Clinical Trials in Oncology (Other)

Overall Status

Completed

CT.gov ID

NCT01099449

Collaborator

National Cancer Institute (NCI) (NIH)

362

Enrollment

405

Locations

Arms

Duration (Months)

0.9

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

RATIONALE: Chemoprotective drugs, such as calcium gluconate and magnesium sulfate, may prevent neurotoxicity caused by oxaliplatin. It is not yet known which administration schedule of calcium gluconate and magnesium sulfate is more effective in preventing neurotoxicity.

PURPOSE: This randomized phase III trial is studying different administration schedules of calcium gluconate and magnesium sulfate and comparing how well they work in neurotoxicity in patients with colon cancer or rectal cancer receiving oxaliplatin-based combination chemotherapy.

Condition or Disease	Intervention/Treatment	Phase
Chemotherapeutic Agent Toxicity Colorectal Cancer Neuropathy Neurotoxicity	Drug: calcium gluconate Drug: magnesium sulfate Other: placebo Drug: oxaliplatin	Phase 3

Detailed Description

OBJECTIVES:

Primary

To determine whether 2 schedules of calcium gluconate and magnesium sulfate infusions (given before and after chemotherapy or just before chemotherapy) can prevent or ameliorate chronic, cumulative oxaliplatin-induced sensory neurotoxicity in patients with colon or rectal cancer receiving adjuvant FOLFOX chemotherapy comprising leucovorin calcium, fluorouracil, and oxaliplatin.

Secondary

To determine whether these 2 infusion schedules can increase the cumulative oxaliplatin doses that can be delivered without dose-limiting chronic neurotoxicity.
To determine whether these 2 infusion schedules can ameliorate acute neuropathy associated with oxaliplatin.
To determine whether these 2 infusion schedules cause adverse events.
To investigate whether these 2 infusions schedules influence patient quality of life.
To describe baseline and post-treatment neurological quantitative sensory testing abnormalities in the study participants.

Tertiary

To explore if polymorphisms in the GSTP1, GSTM1, ERCC2, and XRCC1 genes are associated with early onset of oxaliplatin-induced neurotoxicity.

OUTLINE: This is a multicenter study. Patients are stratified according to age (< 65 years vs ≥ 65 years), gender, regimen (FOLFOX4 vs modified FOLFOX6 vs other), and stage of disease (II vs III vs IV). Patients are randomized to 1 of 3 treatment arms.

Arm I: Patients receive calcium gluconate IV and magnesium sulfate IV over 30 minutes immediately before and after oxaliplatin administration (part of FOLFOX chemotherapy comprising leucovorin calcium, fluorouracil, and oxaliplatin).
Arm II: Patients receive placebo IV over 30 minutes immediately before and after oxaliplatin administration (part of FOLFOX chemotherapy).
Arm III: Patients receive calcium gluconate and magnesium sulfate IV over 30 minutes immediately before and placebo IV over 30 minutes immediately after oxaliplatin administration (part of FOLFOX chemotherapy).

In all arms, courses repeat every 14 days for 6 months in the absence of disease progression or unacceptable toxicity.

Blood samples are collected before the second course of treatment for translational research.

Patients complete questionnaires on side effects, quality of life, and chemotherapy-induced peripheral neuropathy periodically.

After completion of study treatment, patients are followed up at 3, 6, 12, and 18 months.

Study Design

Study Type:

Interventional

Actual Enrollment :

362 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Supportive Care

Official Title:

A Phase III Randomized, Placebo-Controlled, Double-Blind Study of Intravenous Calcium/Magnesium in Two Different Versions to Prevent Oxaliplatin-Induced Sensory Neurotoxicity

Study Start Date :

Jun 1, 2010

Actual Primary Completion Date :

Dec 1, 2012

Actual Study Completion Date :

Mar 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm I Patients receive calcium gluconate and magnesium sulfate IV over 30 minutes immediately before and after oxaliplatin administration (part of FOLFOX chemotherapy comprising leucovorin calcium, fluorouracil, and oxaliplatin).	Drug: calcium gluconate Given IV Drug: magnesium sulfate Given IV Drug: oxaliplatin
Placebo Comparator: Arm II Patients receive placebo IV over 30 minutes immediately before and after oxaliplatin administration (part of FOLFOX chemotherapy).	Other: placebo Given IV Drug: oxaliplatin
Experimental: Arm III Patients receive calcium gluconate and magnesium sulfate IV over 30 minutes immediately before and placebo IV over 30 minutes immediately after oxaliplatin administration (part of FOLFOX chemotherapy).	Drug: calcium gluconate Given IV Drug: magnesium sulfate Given IV Other: placebo Given IV Drug: oxaliplatin

Arm

Intervention/Treatment

Experimental: Arm I

Patients receive calcium gluconate and magnesium sulfate IV over 30 minutes immediately before and after oxaliplatin administration (part of FOLFOX chemotherapy comprising leucovorin calcium, fluorouracil, and oxaliplatin).

Drug: calcium gluconate

Given IV

Drug: magnesium sulfate

Given IV

Drug: oxaliplatin

Placebo Comparator: Arm II

Patients receive placebo IV over 30 minutes immediately before and after oxaliplatin administration (part of FOLFOX chemotherapy).

Other: placebo

Given IV

Drug: oxaliplatin

Experimental: Arm III

Patients receive calcium gluconate and magnesium sulfate IV over 30 minutes immediately before and placebo IV over 30 minutes immediately after oxaliplatin administration (part of FOLFOX chemotherapy).

Drug: calcium gluconate

Given IV

Drug: magnesium sulfate

Given IV

Other: placebo

Given IV

Drug: oxaliplatin

Outcome Measures

Primary Outcome Measures

Sensory Area Under the Curve(AUC) Score. Oxaliplatin-induced Sensory Neuropathy as Repeatedly Measured by the EORTC QLQ-CIPN20 Sensory Subscale During Chemotherapy [Up to 18 months]
The oxaliplatin-induced sensory neuropathy as repeatedly measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire of Chemotherapy-induced peripheral neuropathy (EORTC QLQ-CIPN20) sensory subscale during the chemotherapy. This is a multivariate repeated measurement of CIPN with possibly variable cycles for every patient. The CIPN sensory subscale will be calculated by standard scoring algorithm and converted to 0-100 scale, where higher scores represent a higher quality of life. Rather than choosing the CIPN20 sensory subscale at a fixed cycle of chemotherapy, we will adopt a summary measure, area under the curve (AUC) of CIPN20 sensory subscale as the primary endpoint. This AUC will be prorated by the number of chemotherapy cycles patients received.

Secondary Outcome Measures

Area Under the Curve (AUC) of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire of Chemotherapy-induced Peripheral Neuropathy (EORTC QLQ-CIPN20) Autonomic Neuropathy Subscale Scores [Up to 18 months]
The oxaliplatin-induced autonomic neuropathy as repeatedly measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire of Chemotherapy-induced peripheral neuropathy (EORTC QLQ-CIPN20) autonomic subscale during the chemotherapy. This is a multivariate repeated measurement of CIPN with possibly variable cycles for every patient. The CIPN autonomic subscale will be calculated by standard scoring algorithm and converted to 0-100 scale, where higher scores represent a higher quality of life. Rather than choosing the CIPN20 autonomic subscale at a fixed cycle of chemotherapy, we will adopt a summary measure, area under the curve (AUC) of CIPN20 autonomic subscale as the endpoint. This AUC will be prorated by the number of chemotherapy cycles patients received.
Area Under the Curve (AUC) of European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire of Chemotherapy-induced Peripheral Neuropathy (EORTC QLQ-CIPN20) Motor Neuropathy Subscale Scores [Up to 18 Months]
The oxaliplatin-induced motor neuropathy as repeatedly measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire of Chemotherapy-induced peripheral neuropathy (EORTC QLQ-CIPN20) motor neuropathy subscale during the chemotherapy. This is a multivariate repeated measurement of CIPN with possibly variable cycles for every patient. The CIPN motor neuropathy subscale will be calculated by standard scoring algorithm and converted to 0-100 scale, where higher scores represent a higher quality of life. Rather than choosing the CIPN20 motor neuropathy subscale at a fixed cycle of chemotherapy, we will adopt a summary measure, area under the curve (AUC) of CIPN20 motor neuropathy subscale as the endpoint. This AUC will be prorated by the number of chemotherapy cycles patients received.
Percentage of Patients Experiencing Grade 2+ and Grade 3+ Chronic Cumulative Neurotoxicity. [Up to 18 months]
Grades are determined by the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE version 4.0) and oxaliplatin-specific neurotoxicity scale, during and after chemotherapy. Higher grades symbolize greater severity of the adverse event.
Time to Onset of Grade 2+ and Grade 3+ Chronic Cumulative Neurotoxicity and the Duration of the Chronic Cumulative Neurotoxicity During and After Chemotherapy [Up to 18 months]
Time to onset of grade 2+ and grade 3+ chronic cumulative neurotoxicity, the duration of the chronic cumulative neurotoxicity during and after the adjuvant oxaliplatin-based chemotherapy. Grades are determined by the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE version 4.0) and oxaliplatin-specific neurotoxicity scale, during and after chemotherapy. Higher grades symbolize greater severity of the adverse event.
Cumulative Oxaliplatin Doses That Can be Administered Without Dose-limiting Chronic Neurotoxicity [Up to 18 months]
A patient has a dose-limiting chronic neurotoxicity when they discontinue oxaliplatin-based chemotherapy because of neurotoxicity.
Percentage of Patients Discontinuing Oxaliplatin-based Chemotherapy Because of Neurotoxicity [Up to 18 months]
Percentage of Patients With Acute Neuropathy Associated With Oxaliplatin [Up to 18 months]
This is the percent of patients who scored >=50 in all sequences of all cycles by arm for side effect Q1: Sensitivity to touching cold. This is a> repeated measurement of CIPN with possibly variable cycles for every patient. The CIPN subscale will be calculated by standard scoring algorithm and converted to 0-100 scale. Where 0 is no sensitivity and 100 is as bad as it can be.
Incidence of Calcium Gluconate and Magnesium Sulfate-induced Adverse Events as Measured by CTCAE Version 4.0 [Up to 18 months]
Area Under the Curve (AUC) of Patient-reported Quality of Life (QOL) as Measured by the Supplemental QOL Questionnaire [Up to 18 months]
This is a multivariate repeated measurement of CIPN with possibly variable cycles for every patient. The supplemental quality of life (QOL) subscale will be calculated by standard scoring algorithm and converted to 0-100 scale, where higher scores represent a higher quality of life. Rather than choosing the subscale at a fixed cycle of chemotherapy, we will adopt a summary measure, area under the curve (AUC) . This AUC will be prorated by the number of chemotherapy cycles patients received.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

DISEASE CHARACTERISTICS:

Histologically confirmed adenocarcinoma of the colon or rectum
Has undergone curative resection and is considered to have stage II or III disease or completely resected stage IV disease with no evidence of residual tumor
Scheduled to receive 6 months of oxaliplatin-based adjuvant chemotherapy with 85 mg/m^2 oxaliplatin every 2 weeks (this includes, for instance, FOLFOX4 or modified FOLFOX6)
Patients receiving bevacizumab or cetuximab in combination with FOLFOX as part of a clinical trial or clinical practice are eligible

PATIENT CHARACTERISTICS:

ECOG performance status 0-2
WBC ≥ 3,000/mm^3
ANC ≥ 1,500/mm^3
Platelet count ≥ 100,000/mm^3
Hemoglobin ≥ 10.0 g/dL
Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
Serum creatinine ≤ 1.5 times ULN
Serum calcium ≤ 1.2 times ULN
Serum magnesium ≤ 1.2 times ULN
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
Able to complete questionnaires (alone or with assistance)
Able to comply with study treatment
Willing to return to enrolling institution for follow-up
Willing to provide blood sample for research purposes
No pre-existing peripheral neuropathy of any grade
No family history of a genetic/familial neuropathy
No second or third degree AV heart block or a history of second or third degree heart block
Bundle branch blocks are allowed.
No other medical conditions that, in the opinion of the treating physician, would make this protocol unreasonably hazardous for the patient

PRIOR CONCURRENT THERAPY:

See Disease Characteristics
Central venous access line present, or scheduled to have a central line placed before starting chemotherapy and study treatment
No prior treatment with neurotoxic chemotherapy (e.g., oxaliplatin, cisplatin, taxanes, or vinca alkaloids)
No concurrent digitalis medication
No concurrent treatment with the anticonvulsants carbamazepine (e.g., Tegretol®), phenytoin (e.g., Dilantin®), valproic acid (e.g., Depakene®), gabapentin (Neurontin®), or pregabalin (Lyrica®)
No concurrent neurotropic agents, including venlafaxine (Effexor), desvenlafaxine (Pristiq®), milnacipran (Savella®), or duloxetine (Cymbalta)
No concurrent tricyclic antidepressants (such as amitryptilline), or any other agent specifically being given to prevent or treat neuropathy
No concurrent drugs given as a neuroprotectant

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fairbanks Cancer Treatment Center at Fairbanks Memorial Hospital	Fairbanks	Alaska	United States	99701
2	Kaiser Permanente - Deer Valley	Antioch	California	United States	94531
3	North Bay Cancer Center	Fairfield	California	United States	94533
4	Kaiser Permanente - Fremont	Fremont	California	United States	94538
5	Kaiser Permanente Fresno Medical Center	Fresno	California	United States	93720
6	Kaiser Permanente Medical Center - Hayward	Hayward	California	United States	94545
7	Kaiser Permanente Medical Center - Oakland	Oakland	California	United States	94611
8		Pismo Beach	California	United States	93449
9	Kaiser Permanente Medical Center - Redwood City	Redwood City	California	United States	94063
10	Kaiser Permanente Medical Center - Richmond	Richmond	California	United States	94801
11	Kaiser Permanente Medical Center - Roseville	Roseville	California	United States	95661
12	South Sacramento Kaiser-Permanente Medical Center	Sacramento	California	United States	95823
13	Kaiser Permanente Medical Center - Sacramento	Sacramento	California	United States	95825
14	Kaiser Permanente Medical Center - San Francisco Geary Campus	San Francisco	California	United States	94115
15	Kaiser Permanente Medical Center - Santa Teresa	San Jose	California	United States	95119
16	Kaiser Foundation Hospital - San Rafael	San Rafael	California	United States	94903
17	Kaiser Permanente Medical Center - Santa Clara Kiely Campus	Santa Clara	California	United States	95051
18	Kaiser Permanente Medical Center - Santa Rosa	Santa Rosa	California	United States	95403
19	Kaiser Permanente Medical Center - South San Francisco	South San Francisco	California	United States	94080
20	Kaiser Permanente Medical Facility - Stockton	Stockton	California	United States	95210
21	Kaiser Permanente Medical Center - Vacaville	Vacaville	California	United States	95688
22	Kaiser Permanente Medical Center - Vallejo	Vallejo	California	United States	94589
23	Kaiser Permanente Medical Center - Walnut Creek	Walnut Creek	California	United States	94596
24	Aurora Presbyterian Hospital	Aurora	Colorado	United States	80012
25	Boulder Community Hospital	Boulder	Colorado	United States	80301-9019
26	Penrose Cancer Center at Penrose Hospital	Colorado Springs	Colorado	United States	80933
27	St. Anthony Central Hospital	Denver	Colorado	United States	80204
28	Kaiser Permanente - Denver	Denver	Colorado	United States	80205
29	Porter Adventist Hospital	Denver	Colorado	United States	80210
30	Presbyterian - St. Luke's Medical Center	Denver	Colorado	United States	80218
31	St. Joseph Hospital	Denver	Colorado	United States	80218
32	Rose Medical Center	Denver	Colorado	United States	80220
33	CCOP - Colorado Cancer Research Program	Denver	Colorado	United States	80224-2522
34	Swedish Medical Center	Englewood	Colorado	United States	80110
35	St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center	Grand Junction	Colorado	United States	81502
36	North Colorado Medical Center	Greeley	Colorado	United States	80631
37	Kaiser Permanente - Lafayette	Lafayette	Colorado	United States	80026
38	Sky Ridge Medical Center	Lone Tree	Colorado	United States	80124
39	Hope Cancer Care Center at Longmont United Hospital	Longmont	Colorado	United States	80501
40	McKee Medical Center	Loveland	Colorado	United States	80539
41	St. Mary - Corwin Regional Medical Center	Pueblo	Colorado	United States	81004
42	North Suburban Medical Center	Thornton	Colorado	United States	80229
43	Exempla Lutheran Medical Center	Wheat Ridge	Colorado	United States	80033
44	Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center	Hartford	Connecticut	United States	06105
45	Norwalk Hospital	Norwalk	Connecticut	United States	06856
46	Tunnell Cancer Center at Beebe Medical Center	Lewes	Delaware	United States	19958
47	CCOP - Christiana Care Health Services	Newark	Delaware	United States	19713
48	North Broward Medical Center	Deerfield Beach	Florida	United States	33064-3596
49	Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital	Fort Lauderdale	Florida	United States	33308
50	Broward General Medical Center Cancer Center	Fort Lauderdale	Florida	United States	33316
51	Ella Milbank Foshay Cancer Center at Jupiter Medical Center	Jupiter	Florida	United States	33458
52	CCOP - Mount Sinai Medical Center	Miami Beach	Florida	United States	33140
53	Florida Hospital Cancer Institute at Florida Hospital Orlando	Orlando	Florida	United States	32803-1273
54	Phoebe Cancer Center at Phoebe Putney Memorial Hospital	Albany	Georgia	United States	31701
55	Piedmont Hospital	Atlanta	Georgia	United States	30309
56	Northside Hospital Cancer Center	Atlanta	Georgia	United States	30342-1611
57	Saint Joseph's Hospital of Atlanta	Atlanta	Georgia	United States	30342-1701
58	CCOP - Atlanta Regional	Atlanta	Georgia	United States	30342
59	WellStar Cobb Hospital	Austell	Georgia	United States	30106
60	John B. Amos Cancer Center	Columbus	Georgia	United States	31904
61	Charles B. Eberhart Cancer Center at DeKalb Medical Center	Decatur	Georgia	United States	30033
62	Veterans Affairs Medical Center - Atlanta (Decatur)	Decatur	Georgia	United States	30033
63	Piedmont Fayette Hospital	Fayetteville	Georgia	United States	30214
64	Gwinnett Medical Center	Lawrenceville	Georgia	United States	30045
65	Kennestone Cancer Center at Wellstar Kennestone Hospital	Marietta	Georgia	United States	30060
66	Southern Regional Medical Center	Riverdale	Georgia	United States	30274-2600
67	Harbin Clinic Cancer Center - Medical Oncology	Rome	Georgia	United States	30165
68	Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center	Savannah	Georgia	United States	31403-3089
69	Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler	Savannah	Georgia	United States	31405
70	Kapiolani Medical Center at Pali Momi	'Aiea	Hawaii	United States	96701
71	Cancer Research Center of Hawaii	Honolulu	Hawaii	United States	96813
72	OnCare Hawaii, Incorporated - Lusitana	Honolulu	Hawaii	United States	96813
73	Queen's Cancer Institute at Queen's Medical Center	Honolulu	Hawaii	United States	96813
74	Straub Clinic and Hospital, Incorporated	Honolulu	Hawaii	United States	96813
75	Hawaii Medical Center - East	Honolulu	Hawaii	United States	96817
76	OnCare Hawaii, Incorporated - Kuakini	Honolulu	Hawaii	United States	96817
77	Kaiser Permanente - Moanalua Medical Center and Clinic	Honolulu	Hawaii	United States	96819
78	Kapiolani Medical Center for Women and Children	Honolulu	Hawaii	United States	96826
79	Tripler Army Medical Center	Honolulu	Hawaii	United States	96859
80	Maui Memorial Medical Center	Wailuku	Hawaii	United States	96793
81	Pacific Cancer Institute - Maui	Wailuku	Hawaii	United States	96793
82	Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center	Boise	Idaho	United States	83706
83	St. Joseph Regional Medical Center	Lewiston	Idaho	United States	83501
84	Rush-Copley Cancer Care Center	Aurora	Illinois	United States	60504
85	Illinois CancerCare - Bloomington	Bloomington	Illinois	United States	61701
86	Graham Hospital	Canton	Illinois	United States	61520
87	Illinois CancerCare - Canton	Canton	Illinois	United States	61520
88	Illinois CancerCare - Carthage	Carthage	Illinois	United States	62321
89	Memorial Hospital	Carthage	Illinois	United States	62321
90	University of Illinois Cancer Center	Chicago	Illinois	United States	60612-7243
91	Louis A. Weiss Memorial Hospital	Chicago	Illinois	United States	60640
92	Decatur Memorial Hospital Cancer Care Institute	Decatur	Illinois	United States	62526
93	Eureka Community Hospital	Eureka	Illinois	United States	61530
94	Illinois CancerCare - Eureka	Eureka	Illinois	United States	61530
95	Galesburg Clinic, PC	Galesburg	Illinois	United States	61401
96	Illinois CancerCare - Galesburg	Galesburg	Illinois	United States	61401
97	Illinois CancerCare - Havana	Havana	Illinois	United States	62644
98	Mason District Hospital	Havana	Illinois	United States	62644
99	Illinois CancerCare - Kewanee Clinic	Kewanee	Illinois	United States	61443
100	Illinois CancerCare - Macomb	Macomb	Illinois	United States	61455
101	McDonough District Hospital	Macomb	Illinois	United States	61455
102	Trinity Cancer Center at Trinity Medical Center - 7th Street Campus	Moline	Illinois	United States	61265
103		Moline	Illinois	United States	61265
104	Illinois CancerCare - Monmouth	Monmouth	Illinois	United States	61462
105	BroMenn Regional Medical Center	Normal	Illinois	United States	61761
106	Community Cancer Center	Normal	Illinois	United States	61761
107	Illinois CancerCare - Community Cancer Center	Normal	Illinois	United States	61761
108	Community Hospital of Ottawa	Ottawa	Illinois	United States	61350
109	Oncology Hematology Associates of Central Illinois, PC - Ottawa	Ottawa	Illinois	United States	61350
110	Cancer Treatment Center at Pekin Hospital	Pekin	Illinois	United States	61554
111	Illinois CancerCare - Pekin	Pekin	Illinois	United States	61603
112	Proctor Hospital	Peoria	Illinois	United States	61614
113	CCOP - Illinois Oncology Research Association	Peoria	Illinois	United States	61615
114	Oncology Hematology Associates of Central Illinois, PC - Peoria	Peoria	Illinois	United States	61615
115	Methodist Medical Center of Illinois	Peoria	Illinois	United States	61636
116	Illinois CancerCare - Peru	Peru	Illinois	United States	61354
117	Illinois Valley Community Hospital	Peru	Illinois	United States	61354
118	Illinois CancerCare - Princeton	Princeton	Illinois	United States	61356
119	Perry Memorial Hospital	Princeton	Illinois	United States	61356
120	West Suburban Center for Cancer Care	River Forest	Illinois	United States	60305
121	Illinois CancerCare - Spring Valley	Spring Valley	Illinois	United States	61362
122	Regional Cancer Center at Memorial Medical Center	Springfield	Illinois	United States	62781-0001
123	CCOP - Carle Cancer Center	Urbana	Illinois	United States	61801
124	St. Francis Hospital and Health Centers - Beech Grove Campus	Beech Grove	Indiana	United States	46107
125	Elkhart Clinic, LLC	Elkhart	Indiana	United States	46514-2098
126	Michiana Hematology-Oncology, PC - Elkhart	Elkhart	Indiana	United States	46514
127	Elkhart General Hospital	Elkhart	Indiana	United States	46515
128	Howard Community Hospital	Kokomo	Indiana	United States	46904
129	Center for Cancer Therapy at LaPorte Hospital and Health Services	La Porte	Indiana	United States	46350
130	Clarian Arnett Cancer Care	Lafayette	Indiana	United States	47904
131	Saint Anthony Memorial Health Centers	Michigan City	Indiana	United States	46360
132	Michiana Hematology-Oncology, PC - South Bend	Mishawaka	Indiana	United States	46545-1470
133	Saint Joseph Regional Medical Center	Mishawaka	Indiana	United States	46545-1470
134	Michiana Hematology Oncology PC - Plymouth	Plymouth	Indiana	United States	46563
135	Reid Hospital & Health Care Services	Richmond	Indiana	United States	47374
136	CCOP - Northern Indiana CR Consortium	South Bend	Indiana	United States	46601
137	Memorial Hospital of South Bend	South Bend	Indiana	United States	46601
138	Michiana Hematology Oncology PC - La Porte	Westville	Indiana	United States	46391
139		Bettendorf	Iowa	United States	52722
140	Cedar Rapids Oncology Associates	Cedar Rapids	Iowa	United States	52403
141	Mercy Regional Cancer Center at Mercy Medical Center	Cedar Rapids	Iowa	United States	52403
142	Medical Oncology and Hematology Associates - West Des Moines	Clive	Iowa	United States	50325
143	Mercy Cancer Center - West Lakes	Clive	Iowa	United States	50325
144	CCOP - Iowa Oncology Research Association	Des Moines	Iowa	United States	50309
145	John Stoddard Cancer Center at Iowa Methodist Medical Center	Des Moines	Iowa	United States	50309
146	Medical Oncology and Hematology Associates at John Stoddard Cancer Center	Des Moines	Iowa	United States	50309
147	Medical Oncology and Hematology Associates at Mercy Cancer Center	Des Moines	Iowa	United States	50314
148	Mercy Cancer Center at Mercy Medical Center - Des Moines	Des Moines	Iowa	United States	50314
149	John Stoddard Cancer Center at Iowa Lutheran Hospital	Des Moines	Iowa	United States	50316
150	Siouxland Hematology-Oncology Associates, LLP	Sioux City	Iowa	United States	51101
151	Mercy Medical Center - Sioux City	Sioux City	Iowa	United States	51102
152	St. Luke's Regional Medical Center	Sioux City	Iowa	United States	51104
153	Covenant Cancer Treatment Center	Waterloo	Iowa	United States	50702
154	Methodist West Hospital	West Des Moines	Iowa	United States	50266-7700
155	Cancer Center of Kansas, PA - Chanute	Chanute	Kansas	United States	66720
156	Cancer Center of Kansas, PA - Dodge City	Dodge City	Kansas	United States	67801
157	Cancer Center of Kansas, PA - El Dorado	El Dorado	Kansas	United States	67042
158	Cancer Center of Kansas - Fort Scott	Fort Scott	Kansas	United States	66701
159	Cancer Center of Kansas-Independence	Independence	Kansas	United States	67301
160	Cancer Center of Kansas, PA - Kingman	Kingman	Kansas	United States	67068
161	Lawrence Memorial Hospital	Lawrence	Kansas	United States	66044
162	Cancer Center of Kansas, PA - Liberal	Liberal	Kansas	United States	67901
163	Cancer Center of Kansas, PA - McPherson	McPherson	Kansas	United States	67460
164	Cancer Center of Kansas, PA - Newton	Newton	Kansas	United States	67114
165	Menorah Medical Center	Overland Park	Kansas	United States	66209
166	Saint Luke's Hospital - South	Overland Park	Kansas	United States	66213
167	Cancer Center of Kansas, PA - Parsons	Parsons	Kansas	United States	67357
168	CCOP - Kansas City	Prairie Village	Kansas	United States	66208
169	Cancer Center of Kansas, PA - Pratt	Pratt	Kansas	United States	67124
170	Cancer Center of Kansas, PA - Salina	Salina	Kansas	United States	67401
171	Cancer Center of Kansas, PA - Wellington	Wellington	Kansas	United States	67152
172	Associates in Womens Health, PA - North Review	Wichita	Kansas	United States	67208
173	Cancer Center of Kansas, PA - Medical Arts Tower	Wichita	Kansas	United States	67208
174	Cancer Center of Kansas, PA - Wichita	Wichita	Kansas	United States	67214
175	CCOP - Wichita	Wichita	Kansas	United States	67214
176	Via Christi Cancer Center at Via Christi Regional Medical Center	Wichita	Kansas	United States	67214
177	Cancer Center of Kansas, PA - Winfield	Winfield	Kansas	United States	67156
178	MBCCOP - LSU Health Sciences Center	New Orleans	Louisiana	United States	70112
179	Medical Center of Louisiana - New Orleans	New Orleans	Louisiana	United States	70112
180	York Hospital's Oncology Treatment Center	York	Maine	United States	03909
181	Shore Regional Cancer Center at Memorial Hospital - Easton	Easton	Maryland	United States	21601
182	Union Hospital of Cecil County	Elkton	Maryland	United States	21921
183	Sturdy Memorial Hospital	Attleboro	Massachusetts	United States	02703
184	Boston University Cancer Research Center	Boston	Massachusetts	United States	02118
185	Caritas St. Elizabeth's Medical Center	Brighton	Massachusetts	United States	02135-2997
186	Hickman Cancer Center at Bixby Medical Center	Adrian	Michigan	United States	49221
187	Saint Joseph Mercy Cancer Center	Ann Arbor	Michigan	United States	48106-0995
188	CCOP - Michigan Cancer Research Consortium	Ann Arbor	Michigan	United States	48106
189	Oakwood Cancer Center at Oakwood Hospital and Medical Center	Dearborn	Michigan	United States	48123-2500
190	Green Bay Oncology, Limited - Escanaba	Escanaba	Michigan	United States	49431
191	Genesys Hurley Cancer Institute	Flint	Michigan	United States	48503
192	Hurley Medical Center	Flint	Michigan	United States	48503
193	Genesys Regional Medical Center	Grand Blanc	Michigan	United States	48439
194	Van Elslander Cancer Center at St. John Hospital and Medical Center	Grosse Pointe Woods	Michigan	United States	48236
195	Dickinson County Healthcare System	Iron Mountain	Michigan	United States	49801
196	Foote Memorial Hospital	Jackson	Michigan	United States	49201
197	Borgess Medical Center	Kalamazoo	Michigan	United States	49001
198	West Michigan Cancer Center	Kalamazoo	Michigan	United States	49007-3731
199	Bronson Methodist Hospital	Kalamazoo	Michigan	United States	49007
200	Sparrow Regional Cancer Center	Lansing	Michigan	United States	48912-1811
201	St. Mary Mercy Hospital	Livonia	Michigan	United States	48154
202	Community Cancer Center of Monroe	Monroe	Michigan	United States	48162
203	Mercy Memorial Hospital - Monroe	Monroe	Michigan	United States	48162
204	Michiana Hematology Oncology PC - Niles	Niles	Michigan	United States	49120
205	St. Joseph Mercy Oakland	Pontiac	Michigan	United States	48341-2985
206	Mercy Regional Cancer Center at Mercy Hospital	Port Huron	Michigan	United States	48060
207	William Beaumont Hospital - Royal Oak Campus	Royal Oak	Michigan	United States	48073
208	Seton Cancer Institute at Saint Mary's - Saginaw	Saginaw	Michigan	United States	48601
209	Lakeland Regional Cancer Care Center - St. Joseph	Saint Joseph	Michigan	United States	49085
210	Lakeside Cancer Specialists, PLLC	Saint Joseph	Michigan	United States	49085
211	St. John Macomb Hospital	Warren	Michigan	United States	48093
212	Duluth Clinic Cancer Center - Duluth	Duluth	Minnesota	United States	55805-1983
213	CCOP - Duluth	Duluth	Minnesota	United States	55805
214	Miller - Dwan Medical Center	Duluth	Minnesota	United States	55805
215	Immanuel St. Joseph's	Mankato	Minnesota	United States	56002
216	Hennepin County Medical Center - Minneapolis	Minneapolis	Minnesota	United States	55415
217	Mayo Clinic Cancer Center	Rochester	Minnesota	United States	55905
218	Regional Cancer Center at Singing River Hospital	Pascagoula	Mississippi	United States	39581
219	Southeast Cancer Center	Cape Girardeau	Missouri	United States	63703
220	Saint Luke's Hospital	Chesterfield	Missouri	United States	63017
221	Goldschmidt Cancer Center	Jefferson City	Missouri	United States	65109
222	Saint Luke's Cancer Institute at Saint Luke's Hospital	Kansas City	Missouri	United States	64111
223	North Kansas City Hospital	Kansas City	Missouri	United States	64116
224	Parvin Radiation Oncology	Kansas City	Missouri	United States	64116
225	Heartland Hematology Oncology Associates, Incorporated	Kansas City	Missouri	United States	64118
226	Research Medical Center	Kansas City	Missouri	United States	64132
227	Saint Luke's East - Lee's Summit	Lee's Summit	Missouri	United States	64086
228	Heartland Regional Medical Center	Saint Joseph	Missouri	United States	64506
229	Saint Joseph Oncology, Incorporated	Saint Joseph	Missouri	United States	64507
230	Saint Louis University Cancer Center	Saint Louis	Missouri	United States	63110
231	St. Anthony's Cancer Center	Saint Louis	Missouri	United States	63128
232	Missouri Baptist Cancer Center	Saint Louis	Missouri	United States	63131
233	Comprehensive Cancer Care, PC	Saint Louis	Missouri	United States	63141
234	CCOP - Montana Cancer Consortium	Billings	Montana	United States	59101
235	St. Vincent Healthcare Cancer Care Services	Billings	Montana	United States	59101
236	Hematology-Oncology Centers of the Northern Rockies - Billings	Billings	Montana	United States	59102
237	Billings Clinic - Downtown	Billings	Montana	United States	59107-7000
238	Bozeman Deaconess Cancer Center	Bozeman	Montana	United States	59715
239	St. James Healthcare Cancer Care	Butte	Montana	United States	59701
240	Big Sky Oncology	Great Falls	Montana	United States	59405-5309
241	Great Falls Clinic - Main Facility	Great Falls	Montana	United States	59405
242	Sletten Cancer Institute at Benefis Healthcare	Great Falls	Montana	United States	59405
243	Northern Montana Hospital	Havre	Montana	United States	59501
244	St. Peter's Hospital	Helena	Montana	United States	59601
245	Glacier Oncology, PLLC	Kalispell	Montana	United States	59901
246	Kalispell Medical Oncology at KRMC	Kalispell	Montana	United States	59901
247	Kalispell Regional Medical Center	Kalispell	Montana	United States	59901
248	Montana Cancer Specialists at Montana Cancer Center	Missoula	Montana	United States	59807-7877
249	Montana Cancer Center at St. Patrick Hospital and Health Sciences Center	Missoula	Montana	United States	59807
250	Cancer Resource Center - Lincoln	Lincoln	Nebraska	United States	68510
251	CCOP - Missouri Valley Cancer Consortium	Omaha	Nebraska	United States	68106
252	Immanuel Medical Center	Omaha	Nebraska	United States	68122
253	Alegant Health Cancer Center at Bergan Mercy Medical Center	Omaha	Nebraska	United States	68124
254	Creighton University Medical Center	Omaha	Nebraska	United States	68131-2197
255	University Medical Center of Southern Nevada	Las Vegas	Nevada	United States	89102
256	CCOP - Nevada Cancer Research Foundation	Las Vegas	Nevada	United States	89106
257	New Hampshire Oncology - Hematology, PA at Payson Center for Cancer Care	Concord	New Hampshire	United States	03301
258	Center for Cancer Care at Exeter Hospital	Exeter	New Hampshire	United States	03833
259	New Hampshire Oncology - Hematology, PA - Hooksett	Hooksett	New Hampshire	United States	03106
260	Lakes Region General Hospital	Laconia	New Hampshire	United States	03246
261	Oncology Center at St. Joseph Hospital	Nashua	New Hampshire	United States	03060
262	Trinitas Comprehensive Cancer Center at Trinitas Hospital	Elizabeth	New Jersey	United States	07207
263	Newark Beth Israel Medical Center	Newark	New Jersey	United States	07112
264	Cancer Institute of New Jersey at Cooper - Voorhees	Voorhees	New Jersey	United States	08043
265	Kings County Hospital Center	Brooklyn	New York	United States	11203
266	SUNY Downstate Medical Center	Brooklyn	New York	United States	11203
267	Veterans Affairs Medical Center - Brooklyn	Brooklyn	New York	United States	11209
268	Bassett Healthcare Regional Cancer Program at Mary Imogene Bassett Hospital	Cooperstown	New York	United States	13326
269	CCOP - Hematology-Oncology Associates of Central New York	East Syracuse	New York	United States	13057
270	Monter Cancer Center of the North Shore-LIJ Health System	Lake Success	New York	United States	11042
271	CCOP - North Shore University Hospital	Manhasset	New York	United States	11030
272	Don Monti Comprehensive Cancer Center at North Shore University Hospital	Manhasset	New York	United States	11030
273	Long Island Jewish Medical Center	New Hyde Park	New York	United States	11040
274	Fitzpatrick Cancer Center at Champlain Valley Physicians Hospital Medical Center	Plattsburgh	New York	United States	12901
275	Randolph Hospital	Asheboro	North Carolina	United States	27203-5400
276	CaroMont Cancer Center at Gaston Memorial Hospital	Gastonia	North Carolina	United States	28053
277	Wayne Memorial Hospital, Incorporated	Goldsboro	North Carolina	United States	27534
278	Moses Cone Regional Cancer Center at Wesley Long Community Hospital	Greensboro	North Carolina	United States	27403-1198
279	Pardee Memorial Hospital	Hendersonville	North Carolina	United States	28791
280	FirstHealth Moore Regional Community Hospital Comprehensive Cancer Center	Pinehurst	North Carolina	United States	28374
281	Annie Penn Cancer Center	Reidsville	North Carolina	United States	27320
282	Rutherford Hospital	Rutherfordton	North Carolina	United States	28139
283	Iredell Memorial Hospital	Statesville	North Carolina	United States	28677
284	Bismarck Cancer Center	Bismarck	North Dakota	United States	58501
285	Medcenter One Hospital Cancer Care Center	Bismarck	North Dakota	United States	58501
286	Mid Dakota Clinic, PC	Bismarck	North Dakota	United States	58501
287	St. Alexius Medical Center Cancer Center	Bismarck	North Dakota	United States	58502
288	Altru Cancer Center at Altru Hospital	Grand Forks	North Dakota	United States	58201
289	Trinity CancerCare Center	Minot	North Dakota	United States	58701
290	McDowell Cancer Center at Akron General Medical Center	Akron	Ohio	United States	44307
291	Wood County Oncology Center	Bowling Green	Ohio	United States	43402
292	MetroHealth Cancer Care Center at MetroHealth Medical Center	Cleveland	Ohio	United States	44109
293	Grandview Hospital	Dayton	Ohio	United States	45405
294	Good Samaritan Hospital	Dayton	Ohio	United States	45406
295	David L. Rike Cancer Center at Miami Valley Hospital	Dayton	Ohio	United States	45409
296	Samaritan North Cancer Care Center	Dayton	Ohio	United States	45415
297	CCOP - Dayton	Dayton	Ohio	United States	45420
298	Community Cancer Center	Elyria	Ohio	United States	44035
299	Hematology Oncology Center	Elyria	Ohio	United States	44035
300	Blanchard Valley Medical Associates	Findlay	Ohio	United States	45840
301	Middletown Regional Hospital	Franklin	Ohio	United States	45005-1066
302	Wayne Hospital	Greenville	Ohio	United States	45331
303	Charles F. Kettering Memorial Hospital	Kettering	Ohio	United States	45429
304	St. Rita's Medical Center	Lima	Ohio	United States	45801
305	Lima Memorial Hospital	Lima	Ohio	United States	45804
306	Northwest Ohio Oncology Center	Maumee	Ohio	United States	43537-1839
307	St. Charles Mercy Hospital	Oregon	Ohio	United States	43616
308	Toledo Clinic - Oregon	Oregon	Ohio	United States	43616
309	North Coast Cancer Care, Incorporated	Sandusky	Ohio	United States	44870
310	Flower Hospital Cancer Center	Sylvania	Ohio	United States	43560
311	Mercy Hospital of Tiffin	Tiffin	Ohio	United States	44883
312	Toledo Hospital	Toledo	Ohio	United States	43606
313	St. Vincent Mercy Medical Center	Toledo	Ohio	United States	43608
314	Medical University of Ohio Cancer Center	Toledo	Ohio	United States	43614
315	CCOP - Toledo Community Hospital	Toledo	Ohio	United States	43617
316	St. Anne Mercy Hospital	Toledo	Ohio	United States	43623
317	Toledo Clinic, Incorporated - Main Clinic	Toledo	Ohio	United States	43623
318	UVMC Cancer Care Center at Upper Valley Medical Center	Troy	Ohio	United States	45373-1300
319	Fulton County Health Center	Wauseon	Ohio	United States	43567
320	United States Air Force Medical Center - Wright-Patterson	Wright-Patterson Air Force Base	Ohio	United States	45433-5529
321	Ruth G. McMillan Cancer Center at Greene Memorial Hospital	Xenia	Ohio	United States	45385
322	Oklahoma University Cancer Institute	Oklahoma City	Oklahoma	United States	73104
323	LaFortune Cancer Center at St. John Medical Center	Tulsa	Oklahoma	United States	74104
324	Natalie Warren Bryant Cancer Center at St. Francis Hospital	Tulsa	Oklahoma	United States	74136
325	Kaiser Permanente Health Care - Portland	Portland	Oregon	United States	97227
326	Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest	Allentown	Pennsylvania	United States	18105
327	Bryn Mawr Hospital	Bryn Mawr	Pennsylvania	United States	19010
328	Geisinger Cancer Institute at Geisinger Health	Danville	Pennsylvania	United States	17822-0001
329	Geisinger Hazleton Cancer Center	Hazleton	Pennsylvania	United States	18201
330	Cancer Center of Paoli Memorial Hospital	Paoli	Pennsylvania	United States	19301-1792
331	Geisinger Medical Group - Scenery Park	State College	Pennsylvania	United States	16801
332	Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center	Wilkes-Barre	Pennsylvania	United States	18711
333	CCOP - Main Line Health	Wynnewood	Pennsylvania	United States	19096
334	Lankenau Cancer Center at Lankenau Hospital	Wynnewood	Pennsylvania	United States	19096
335	Kent County Memorial Hospital	Warwick	Rhode Island	United States	02886
336	AnMed Cancer Center	Anderson	South Carolina	United States	29621
337	Roper St. Francis Cancer Center at Roper Hospital	Charleston	South Carolina	United States	29401
338	Cancer Centers of the Carolinas - Easley	Easley	South Carolina	United States	29640
339	McLeod Regional Medical Center	Florence	South Carolina	United States	29501
340	Bon Secours St. Francis Health System	Greenville	South Carolina	United States	29601
341	Cancer Centers of the Carolinas - Faris Road	Greenville	South Carolina	United States	29605
342	Cancer Centers of the Carolinas - Grove Commons	Greenville	South Carolina	United States	29605
343	Greenville Hospital Cancer Center	Greenville	South Carolina	United States	29605
344	Self Regional Cancer Center at Self Regional Medical Center	Greenwood	South Carolina	United States	29646
345	Cancer Centers of the Carolinas - Greer Medical Oncology	Greer	South Carolina	United States	29650
346	Carolina Blood and Cancer Care Associates, PA	Lancaster	South Carolina	United States	29720
347	Carolina Blood and Cancer Care	Rock Hill	South Carolina	United States	29732
348	Cancer Centers of the Carolinas - Seneca	Seneca	South Carolina	United States	29672
349	CCOP - Upstate Carolina	Spartanburg	South Carolina	United States	29303
350	Gibbs Regional Cancer Center at Spartanburg Regional Medical Center	Spartanburg	South Carolina	United States	29303
351	Cancer Centers of the Carolinas - Spartanburg	Spartanburg	South Carolina	United States	29307
352	Rapid City Regional Hospital	Rapid City	South Dakota	United States	57701
353	Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center	Kingsport	Tennessee	United States	37662
354	Fredericksburg Oncology, Incorporated	Fredericksburg	Virginia	United States	22401
355	Hematology-Oncology Associates of Fredericksburg, Incorporated	Fredericksburg	Virginia	United States	22408
356	Ravenel Oncology Center at Memorial Hospital of Martinsville and Henry County	Martinsville	Virginia	United States	24115
357	Southwest Virginia Regional Cancer Center at Wellmonth Health	Norton	Virginia	United States	24273
358	Overlake Cancer Center at Overlake Hospital Medical Center	Bellevue	Washington	United States	98004
359	St. Joseph Cancer Center	Bellingham	Washington	United States	98225
360	Providence Centralia Hospital	Centralia	Washington	United States	98531-9027
361	Providence Regional Cancer Partnership	Everett	Washington	United States	98201
362	St. Francis Hospital	Federal Way	Washington	United States	98003
363	Cascade Cancer Center at Evergreen Hospital Medical Center	Kirkland	Washington	United States	98033
364	Providence St. Peter Hospital Regional Cancer Center	Olympia	Washington	United States	98506-5166
365	Good Samaritan Cancer Center	Puyallup	Washington	United States	98372
366	CCOP - Virginia Mason Research Center	Seattle	Washington	United States	98101
367	Virginia Mason Medical Center	Seattle	Washington	United States	98101
368	Pacific Medical Center	Seattle	Washington	United States	98104
369	Franciscan Cancer Center at St. Joseph Medical Center	Tacoma	Washington	United States	98405-3004
370	Allenmore Hospital	Tacoma	Washington	United States	98405
371	CCOP - Northwest	Tacoma	Washington	United States	98405
372	MultiCare Regional Cancer Center at Tacoma General Hospital	Tacoma	Washington	United States	98405
373	St. Clare Hospital	Tacoma	Washington	United States	98499
374	Edwards Comprehensive Cancer Center at Cabell Huntington Hospital	Huntington	West Virginia	United States	25701
375	St. Mary's Regional Cancer Center at St. Mary's Medical Center	Huntington	West Virginia	United States	25702
376	Langlade Memorial Hospital	Antigo	Wisconsin	United States	54409
377	Fox Valley Hematology and Oncology - East Grant Street	Appleton	Wisconsin	United States	54911-3496
378	Marshfield Clinic - Chippewa Center	Chippewa Falls	Wisconsin	United States	54729
379	Marshfield Clinic Cancer Care at Regional Cancer Center	Eau Claire	Wisconsin	United States	54701
380	Central Wisconsin Cancer Program at Agnesian HealthCare	Fond Du Lac	Wisconsin	United States	54935
381	Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center	Green Bay	Wisconsin	United States	54301-3526
382	Green Bay Oncology, Limited at St. Mary's Hospital	Green Bay	Wisconsin	United States	54303
383	St. Mary's Hospital Medical Center - Green Bay	Green Bay	Wisconsin	United States	54303
384	St. Vincent Hospital Regional Cancer Center	Green Bay	Wisconsin	United States	54307-3508
385	Mercy Regional Cancer Center	Janesville	Wisconsin	United States	53547
386	Franciscan Skemp Healthcare - La Crosse Campus	La Crosse	Wisconsin	United States	54601
387	Gundersen Lutheran Center for Cancer and Blood	La Crosse	Wisconsin	United States	54601
388	Holy Family Memorial Medical Center Cancer Care Center	Manitowoc	Wisconsin	United States	54221-1450
389	Bay Area Cancer Care Center at Bay Area Medical Center	Marinette	Wisconsin	United States	54143
390	Marshfield Clinic - Marshfield Center	Marshfield	Wisconsin	United States	54449
391	Columbia Saint Mary's Hospital - Ozaukee	Mequon	Wisconsin	United States	53097
392	Columbia-Saint Mary's Cancer Care Center	Milwaukee	Wisconsin	United States	53211
393	Marshfield Clinic - Lakeland Center	Minocqua	Wisconsin	United States	54548
394	Green Bay Oncology, Limited - Oconto Falls	Oconto Falls	Wisconsin	United States	54154
395	All Saints Cancer Center at Wheaton Franciscan Healthcare	Racine	Wisconsin	United States	53405
396	Ministry Medical Group at Saint Mary's Hospital	Rhinelander	Wisconsin	United States	54501
397	St. Nicholas Hospital	Sheboygan	Wisconsin	United States	53081
398	Marshfield Clinic at Saint Michael's Hospital	Stevens Point	Wisconsin	United States	54481
399	Green Bay Oncology, Limited - Sturgeon Bay	Sturgeon Bay	Wisconsin	United States	54235
400	University of Wisconcin Cancer Center at Aspirus Wausau Hospital	Wausau	Wisconsin	United States	54401
401	Oncology Alliance, SC - Milwaukee - West	Wauwatosa	Wisconsin	United States	53226
402	Marshfield Clinic - Weston Center	Weston	Wisconsin	United States	54476
403	Riverview UW Cancer Center at Riverview Hospital	Wisconsin Rapids	Wisconsin	United States	54494
404	Welch Cancer Center at Sheridan Memorial Hospital	Sheridan	Wyoming	United States	82801
405	San Juan City Hospital	San Juan		Puerto Rico	00936

Sponsors and Collaborators

Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)

Investigators

Study Chair: Charles L. Loprinzi, MD, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Alliance for Clinical Trials in Oncology

ClinicalTrials.gov Identifier:

NCT01099449

Other Study ID Numbers:

N08CB
NCCTG-N08CB
CDR0000669660
NCI-2011-02036

First Posted:

Apr 7, 2010

Last Update Posted:

May 23, 2019

Last Verified:

May 1, 2019

Keywords provided by Alliance for Clinical Trials in Oncology

neurotoxicity

neuropathy

chemotherapeutic agent toxicity

stage II colon cancer

stage III colon cancer

stage IV colon cancer

stage II rectal cancer

stage III rectal cancer

stage IV rectal cancer

adenocarcinoma of the colon

adenocarcinoma of the rectum

Additional relevant MeSH terms:

Neurotoxicity Syndromes

Oxaliplatin

Magnesium Sulfate

Calcium

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail

Arm/Group Title	Calcium Gluconate + Magnesium Sulfate (Pre and Post)	Placebo (Pre and Post)	Calcium Gluconate + Magnesium Sulfate (Pre), Placebo (Post)
Arm/Group Description	Patients receive calcium gluconate and magnesium sulfate IV over 30 minutes immediately before and after oxaliplatin administration (part of FOLFOX chemotherapy comprising leucovorin calcium, fluorouracil, and oxaliplatin).	Patients receive placebo IV over 30 minutes immediately before and after oxaliplatin administration (part of FOLFOX chemotherapy).	Patients receive calcium gluconate and magnesium sulfate IV over 30 minutes immediately before and placebo IV over 30 minutes immediately after oxaliplatin administration (part of FOLFOX chemotherapy).
Period Title: Overall Study
STARTED	118	119	116
COMPLETED	118	119	116
NOT COMPLETED	0	0	0

Baseline Characteristics

Arm/Group Title	Calcium Gluconate + Magnesium Sulfate (Pre and Post)	Placebo (Pre and Post)	Calcium Gluconate + Magnesium Sulfate (Pre), Placebo (Post)	Total
Arm/Group Description	Patients receive calcium gluconate and magnesium sulfate IV over 30 minutes immediately before and after oxaliplatin administration (part of FOLFOX chemotherapy comprising leucovorin calcium, fluorouracil, and oxaliplatin).>> >> calcium gluconate: Given IV>> >> magnesium sulfate: Given IV>> >> oxaliplatin	Patients receive placebo IV over 30 minutes immediately before and after oxaliplatin administration (part of FOLFOX chemotherapy).>> >> placebo: Given IV>> >> oxaliplatin	Patients receive calcium gluconate and magnesium sulfate IV over 30 minutes immediately before and placebo IV over 30 minutes immediately after oxaliplatin administration (part of FOLFOX chemotherapy).>> >> calcium gluconate: Given IV>> >> magnesium sulfate: Given IV>> >> placebo: Given IV>> >> >> >>> oxaliplatin	Total of all reporting groups
Overall Participants	118	119	116	353
Age (years) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [years]	57	56	57	56
Sex: Female, Male (Count of Participants)
Female	62 52.5%	62 52.1%	60 51.7%	184 52.1%
Male	56 47.5%	57 47.9%	56 48.3%	169 47.9%
Region of Enrollment (Count of Participants)
Ecuador	0 0%	1 0.8%	0 0%	1 0.3%
United States	118 100%	118 99.2%	116 100%	352 99.7%

Outcome Measures

1. Primary Outcome

Title	Sensory Area Under the Curve(AUC) Score. Oxaliplatin-induced Sensory Neuropathy as Repeatedly Measured by the EORTC QLQ-CIPN20 Sensory Subscale During Chemotherapy
Description	The oxaliplatin-induced sensory neuropathy as repeatedly measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire of Chemotherapy-induced peripheral neuropathy (EORTC QLQ-CIPN20) sensory subscale during the chemotherapy. This is a multivariate repeated measurement of CIPN with possibly variable cycles for every patient. The CIPN sensory subscale will be calculated by standard scoring algorithm and converted to 0-100 scale, where higher scores represent a higher quality of life. Rather than choosing the CIPN20 sensory subscale at a fixed cycle of chemotherapy, we will adopt a summary measure, area under the curve (AUC) of CIPN20 sensory subscale as the primary endpoint. This AUC will be prorated by the number of chemotherapy cycles patients received.
Time Frame	Up to 18 months

Outcome Measure Data

Analysis Population Description
All enrolled patients with Baseline and more than 1 cycle of Sensory data.

Arm/Group Title	Calcium Gluconate + Magnesium Sulfate (Pre and Post)	Placebo (Pre and Post)	Calcium Gluconate + Magnesium Sulfate (Pre), Placebo (Post)
Arm/Group Description	Patients receive calcium gluconate and magnesium sulfate IV over 30 minutes immediately before and after oxaliplatin administration (part of FOLFOX chemotherapy comprising leucovorin calcium, fluorouracil, and oxaliplatin).> >> > >> calcium gluconate: Given IV> >> > >> magnesium sulfate: Given IV> >> > >> oxaliplatin	Patients receive placebo IV over 30 minutes immediately before and after oxaliplatin administration (part of FOLFOX chemotherapy).> >> > >> placebo: Given IV> >> > >> oxaliplatin	Patients receive calcium gluconate and magnesium sulfate IV over 30 minutes immediately before and placebo IV over 30 minutes immediately after oxaliplatin administration (part of FOLFOX chemotherapy).> >> > >> calcium gluconate: Given IV> >> > >> magnesium sulfate: Given IV> >> > >> placebo: Given IV> >> > >> oxaliplatin
Measure Participants	110	106	110
Mean (Standard Deviation) [score on a scale]	89.2 (8.5)	88.3 (9.7)	87.1 (9.9)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Calcium Gluconate + Magnesium Sulfate (Pre and Post), Placebo (Pre and Post)
	Comments	Two-sample t-tests or Wilcoxon rank-sum tests will be used>> to compare the AUC of CIPN sensory subscale between each of the two schedules of>> Ca/Mg infusions vs placebo arms at the 2.5% significance level. If the CIPN sensory>> subscales are observed to be unbalanced, we will adjust for the baseline CIPN sensory>> subscale scores from the AUC or incorporate them as a covariate in generalized linear>> regression model.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Two-sample t-tests or Wilcoxon rank-sum tests will be used as in>> primary analysis.

Statistical Test of Hypothesis	p-Value	.73
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo (Pre and Post), Calcium Gluconate + Magnesium Sulfate (Pre), Placebo (Post)
	Comments	Two-sample t-tests or Wilcoxon rank-sum tests will be used>> to compare the AUC of CIPN sensory subscale between each of the two schedules of>> Ca/Mg infusions vs placebo arms at the 2.5% significance level. If the CIPN sensory>> subscales are observed to be unbalanced, we will adjust for the baseline CIPN sensory>> subscale scores from the AUC or incorporate them as a covariate in generalized linear>> regression model.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Two-sample t-tests or Wilcoxon rank-sum tests will be used as in>> primary analysis.

Statistical Test of Hypothesis	p-Value	.29
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

2. Secondary Outcome

Title	Area Under the Curve (AUC) of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire of Chemotherapy-induced Peripheral Neuropathy (EORTC QLQ-CIPN20) Autonomic Neuropathy Subscale Scores
Description	The oxaliplatin-induced autonomic neuropathy as repeatedly measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire of Chemotherapy-induced peripheral neuropathy (EORTC QLQ-CIPN20) autonomic subscale during the chemotherapy. This is a multivariate repeated measurement of CIPN with possibly variable cycles for every patient. The CIPN autonomic subscale will be calculated by standard scoring algorithm and converted to 0-100 scale, where higher scores represent a higher quality of life. Rather than choosing the CIPN20 autonomic subscale at a fixed cycle of chemotherapy, we will adopt a summary measure, area under the curve (AUC) of CIPN20 autonomic subscale as the endpoint. This AUC will be prorated by the number of chemotherapy cycles patients received.
Time Frame	Up to 18 months

Outcome Measure Data

Analysis Population Description
All patients with Baseline and more than one cycle of EORTC CIPN-20 Autonomic data.

Arm/Group Title	Calcium Gluconate + Magnesium Sulfate (Pre and Post)	Placebo (Pre and Post)	Calcium Gluconate + Magnesium Sulfate (Pre), Placebo (Post)
Arm/Group Description	Patients receive calcium gluconate and magnesium sulfate IV over 30 minutes immediately before and after oxaliplatin administration (part of FOLFOX chemotherapy comprising leucovorin calcium, fluorouracil, and oxaliplatin).> >> > >> calcium gluconate: Given IV> >> > >> magnesium sulfate: Given IV> >> > >> oxaliplatin	Patients receive placebo IV over 30 minutes immediately before and after oxaliplatin administration (part of FOLFOX chemotherapy).> >> > >> placebo: Given IV> >> > >> oxaliplatin	Patients receive calcium gluconate and magnesium sulfate IV over 30 minutes immediately before and placebo IV over 30 minutes immediately after oxaliplatin administration (part of FOLFOX chemotherapy).> >> > >> calcium gluconate: Given IV> >> > >> magnesium sulfate: Given IV> >> > >> placebo: Given IV> >> > >> oxaliplatin
Measure Participants	108	102	111
Mean (Standard Deviation) [score on a scale]	89.8 (12.5)	86.7 (14.3)	84.5 (15.1)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Calcium Gluconate + Magnesium Sulfate (Pre and Post), Placebo (Pre and Post)
	Comments	We will not adjust p-values (or significance level) for multiple>> comparisons among the numerous hypothesis testings of secondary endpoints due to the>> exploratory nature of these secondary analyses. The significance results from secondary>> analyses will be interpreted cautiously in a hypothesis-generating fashion.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Two-sample t-tests or Wilcoxon rank-sum tests will be used as in>> primary analysis.

Statistical Test of Hypothesis	p-Value	.054
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo (Pre and Post), Calcium Gluconate + Magnesium Sulfate (Pre), Placebo (Post)
	Comments	We will not adjust p-values (or significance level) for multiple>> comparisons among the numerous hypothesis testings of secondary endpoints due to the>> exploratory nature of these secondary analyses. The significance results from secondary>> analyses will be interpreted cautiously in a hypothesis-generating fashion.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Two-sample t-tests or Wilcoxon rank-sum tests will be used as in>> primary analysis.

Statistical Test of Hypothesis	p-Value	.27
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

3. Secondary Outcome

Title	Area Under the Curve (AUC) of European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire of Chemotherapy-induced Peripheral Neuropathy (EORTC QLQ-CIPN20) Motor Neuropathy Subscale Scores
Description	The oxaliplatin-induced motor neuropathy as repeatedly measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire of Chemotherapy-induced peripheral neuropathy (EORTC QLQ-CIPN20) motor neuropathy subscale during the chemotherapy. This is a multivariate repeated measurement of CIPN with possibly variable cycles for every patient. The CIPN motor neuropathy subscale will be calculated by standard scoring algorithm and converted to 0-100 scale, where higher scores represent a higher quality of life. Rather than choosing the CIPN20 motor neuropathy subscale at a fixed cycle of chemotherapy, we will adopt a summary measure, area under the curve (AUC) of CIPN20 motor neuropathy subscale as the endpoint. This AUC will be prorated by the number of chemotherapy cycles patients received.
Time Frame	Up to 18 Months

Outcome Measure Data

Analysis Population Description
All patients with at least baseline and more than 1 cycle of Motor Neuropathy data.

Arm/Group Title	Calcium Gluconate + Magnesium Sulfate (Pre and Post)	Placebo (Pre and Post)	Calcium Gluconate + Magnesium Sulfate (Pre), Placebo (Post)
Arm/Group Description	Patients receive calcium gluconate and magnesium sulfate IV over 30 minutes immediately before and after oxaliplatin administration (part of FOLFOX chemotherapy comprising leucovorin calcium, fluorouracil, and oxaliplatin).>> >> calcium gluconate: Given IV>> >> magnesium sulfate: Given IV>> >> oxaliplatin	Patients receive placebo IV over 30 minutes immediately before and after oxaliplatin administration (part of FOLFOX chemotherapy).>> >> placebo: Given IV>> >> oxaliplatin	Patients receive calcium gluconate and magnesium sulfate IV over 30 minutes immediately before and placebo IV over 30 minutes immediately after oxaliplatin administration (part of FOLFOX chemotherapy).>> >> calcium gluconate: Given IV>> >> magnesium sulfate: Given IV>> >> placebo: Given IV>> >> oxaliplatin
Measure Participants	110	106	110
Mean (Standard Deviation) [AUC QLQ-CIPN20 Motor Neuropathy Score]	94.1 (7.9)	93.3 (8.0)	91.6 (10.5)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Calcium Gluconate + Magnesium Sulfate (Pre and Post), Placebo (Pre and Post)
	Comments	We will not adjust p-values (or significance level) for multiple>> comparisons among the numerous hypothesis testings of secondary endpoints due to the>> exploratory nature of these secondary analyses. The significance results from secondary>> analyses will be interpreted cautiously in a hypothesis-generating fashion.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Two-sample t-tests or Wilcoxon rank-sum tests will be used as in>> primary analysis.

Statistical Test of Hypothesis	p-Value	.29
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo (Pre and Post), Calcium Gluconate + Magnesium Sulfate (Pre), Placebo (Post)
	Comments	We will not adjust p-values (or significance level) for multiple>> comparisons among the numerous hypothesis testings of secondary endpoints due to the>> exploratory nature of these secondary analyses. The significance results from secondary>> analyses will be interpreted cautiously in a hypothesis-generating fashion.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Two-sample t-tests or Wilcoxon rank-sum tests will be used as in>> primary analysis.

Statistical Test of Hypothesis	p-Value	.25
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

4. Secondary Outcome

Title	Percentage of Patients Experiencing Grade 2+ and Grade 3+ Chronic Cumulative Neurotoxicity.
Description	Grades are determined by the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE version 4.0) and oxaliplatin-specific neurotoxicity scale, during and after chemotherapy. Higher grades symbolize greater severity of the adverse event.
Time Frame	Up to 18 months

Outcome Measure Data

Analysis Population Description
All patients that under went at least one cycle of treatment and were analyzed for chronic cumulative neurotoxicity (NCI CTCAE version 4.0 and oxaliplatin-specific neurotoxicity scale) during and after chemotherapy

Arm/Group Title	Calcium Gluconate + Magnesium Sulfate (Pre and Post)	Placebo (Pre and Post)	Calcium Gluconate + Magnesium Sulfate (Pre), Placebo (Post)
Arm/Group Description	Patients receive calcium gluconate and magnesium sulfate IV over 30 minutes immediately before and after oxaliplatin administration (part of FOLFOX chemotherapy comprising leucovorin calcium, fluorouracil, and oxaliplatin).	Patients receive placebo IV over 30 minutes immediately before and after oxaliplatin administration (part of FOLFOX chemotherapy).	Patients receive calcium gluconate and magnesium sulfate IV over 30 minutes immediately before and placebo IV over 30 minutes immediately after oxaliplatin administration (part of FOLFOX chemotherapy).
Measure Participants	118	119	116
grade 2+	42.7	44.8	46.1
grade 3+	7.7	7.8	7.8

5. Secondary Outcome

Title	Time to Onset of Grade 2+ and Grade 3+ Chronic Cumulative Neurotoxicity and the Duration of the Chronic Cumulative Neurotoxicity During and After Chemotherapy
Description	Time to onset of grade 2+ and grade 3+ chronic cumulative neurotoxicity, the duration of the chronic cumulative neurotoxicity during and after the adjuvant oxaliplatin-based chemotherapy. Grades are determined by the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE version 4.0) and oxaliplatin-specific neurotoxicity scale, during and after chemotherapy. Higher grades symbolize greater severity of the adverse event.
Time Frame	Up to 18 months

Outcome Measure Data

Analysis Population Description
[Not Specified]

Arm/Group Title	Calcium Gluconate + Magnesium Sulfate (Pre and Post)	Placebo (Pre and Post)	Calcium Gluconate + Magnesium Sulfate (Pre), Placebo (Post)
Arm/Group Description	Patients receive calcium gluconate and magnesium sulfate IV over 30 minutes immediately before and after oxaliplatin administration (part of FOLFOX chemotherapy comprising leucovorin calcium, fluorouracil, and oxaliplatin).	Patients receive placebo IV over 30 minutes immediately before and after oxaliplatin administration (part of FOLFOX chemotherapy).	Patients receive calcium gluconate and magnesium sulfate IV over 30 minutes immediately before and placebo IV over 30 minutes immediately after oxaliplatin administration (part of FOLFOX chemotherapy).
Measure Participants	109	108	105
Time to Grade 2 Neuropathy	171	173	171
Time to Grade 3 Neuropathy	NA	208	NA

6. Secondary Outcome

Title	Cumulative Oxaliplatin Doses That Can be Administered Without Dose-limiting Chronic Neurotoxicity
Description	A patient has a dose-limiting chronic neurotoxicity when they discontinue oxaliplatin-based chemotherapy because of neurotoxicity.
Time Frame	Up to 18 months

Outcome Measure Data

Analysis Population Description
All patients that discontinued treatment.

Arm/Group Title	Calcium Gluconate + Magnesium Sulfate (Pre and Post)	Placebo (Pre and Post)	Calcium Gluconate + Magnesium Sulfate (Pre), Placebo (Post)
Arm/Group Description	Patients receive calcium gluconate and magnesium sulfate IV over 30 minutes immediately before and after oxaliplatin administration (part of FOLFOX chemotherapy comprising leucovorin calcium, fluorouracil, and oxaliplatin).	Patients receive placebo IV over 30 minutes immediately before and after oxaliplatin administration (part of FOLFOX chemotherapy).	Patients receive calcium gluconate and magnesium sulfate IV over 30 minutes immediately before and placebo IV over 30 minutes immediately after oxaliplatin administration (part of FOLFOX chemotherapy).
Measure Participants	34	32	28
Mean (Standard Deviation) [Doses]	8.1 (3)	8.4 (2.5)	8.0 (2.6)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Calcium Gluconate + Magnesium Sulfate (Pre and Post), Placebo (Pre and Post)
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Kruskal Wallis Analysis

Statistical Test of Hypothesis	p-Value	.89
	Comments
	Method	Kruskal-Wallis
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo (Pre and Post), Calcium Gluconate + Magnesium Sulfate (Pre), Placebo (Post)
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Kruskal Wallis Analysis

Statistical Test of Hypothesis	p-Value	.496
	Comments
	Method	Kruskal-Wallis
	Comments

7. Secondary Outcome

Title	Percentage of Patients Discontinuing Oxaliplatin-based Chemotherapy Because of Neurotoxicity
Description
Time Frame	Up to 18 months

Outcome Measure Data

Analysis Population Description
All patients that received treatment.

Arm/Group Title	Calcium Gluconate + Magnesium Sulfate (Pre and Post)	Placebo (Pre and Post)	Calcium Gluconate + Magnesium Sulfate (Pre), Placebo (Post)
Arm/Group Description	Patients receive calcium gluconate and magnesium sulfate IV over 30 minutes immediately before and after oxaliplatin administration (part of FOLFOX chemotherapy comprising leucovorin calcium, fluorouracil, and oxaliplatin). >> calcium gluconate: Given IV >> magnesium sulfate: Given IV >> oxaliplatin	Patients receive placebo IV over 30 minutes immediately before and after oxaliplatin administration (part of FOLFOX chemotherapy).	Patients receive calcium gluconate and magnesium sulfate IV over 30 minutes immediately before and placebo IV over 30 minutes immediately after oxaliplatin administration (part of FOLFOX chemotherapy).
Measure Participants	118	119	116
Number [percentage of patients]	34.7	27.7	30.5

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Calcium Gluconate + Magnesium Sulfate (Pre and Post), Placebo (Pre and Post)
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Chi-Squared Analysis

Statistical Test of Hypothesis	p-Value	.52
	Comments
	Method	Chi-squared
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo (Pre and Post), Calcium Gluconate + Magnesium Sulfate (Pre), Placebo (Post)
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Chi-Squared Analysis

Statistical Test of Hypothesis	p-Value	.66
	Comments
	Method	Chi-squared
	Comments

8. Secondary Outcome

Title	Percentage of Patients With Acute Neuropathy Associated With Oxaliplatin
Description	This is the percent of patients who scored >=50 in all sequences of all cycles by arm for side effect Q1: Sensitivity to touching cold. This is a> repeated measurement of CIPN with possibly variable cycles for every patient. The CIPN subscale will be calculated by standard scoring algorithm and converted to 0-100 scale. Where 0 is no sensitivity and 100 is as bad as it can be.
Time Frame	Up to 18 months

Outcome Measure Data

Analysis Population Description
[Not Specified]

Arm/Group Title	Arm I	Arm II	Arm III
Arm/Group Description	Patients receive calcium gluconate and magnesium sulfate IV over 30 minutes immediately before and after oxaliplatin administration (part of FOLFOX chemotherapy comprising leucovorin calcium, fluorouracil, and oxaliplatin).> >> > >> calcium gluconate: Given IV> >> > >> magnesium sulfate: Given IV> >> > >> oxaliplatin	Patients receive placebo IV over 30 minutes immediately before and after oxaliplatin administration (part of FOLFOX chemotherapy).> >> > >> placebo: Given IV> >> > >> oxaliplatin	Patients receive calcium gluconate and magnesium sulfate IV over 30 minutes immediately before and placebo IV over 30 minutes immediately after oxaliplatin administration (part of FOLFOX chemotherapy).> >> > >> calcium gluconate: Given IV> >> > >> magnesium sulfate: Given IV> >> > >> placebo: Given IV> >> > >> oxaliplatin
Measure Participants	110	106	110
Cycle 1	10	13	14
Cycle 2	24	27	28
Cycle 3	32	33	32
Cycle 4	34	37	36
Cycle 5	34	33	39
Cycle 6	31	37	33
Cycle 7	35	34	34
Cycle 8	32	34	33
Cycle 9	34	37	32
Cycle 10	29	39	30
Cycle 11	28	39	33
Cycle 12	27	45	32

9. Secondary Outcome

Title	Incidence of Calcium Gluconate and Magnesium Sulfate-induced Adverse Events as Measured by CTCAE Version 4.0
Description
Time Frame	Up to 18 months

Outcome Measure Data

Analysis Population Description
[Not Specified]

Arm/Group Title	Arm I	Arm II	Arm III
Arm/Group Description	Patients receive calcium gluconate and magnesium sulfate IV over 30 minutes immediately before and after oxaliplatin administration (part of FOLFOX chemotherapy comprising leucovorin calcium, fluorouracil, and oxaliplatin).>> >> calcium gluconate: Given IV>> >> magnesium sulfate: Given IV>> >> oxaliplatin	Patients receive placebo IV over 30 minutes immediately before and after oxaliplatin administration (part of FOLFOX chemotherapy).>> >> placebo: Given IV>> >> oxaliplatin	Patients receive calcium gluconate and magnesium sulfate IV over 30 minutes immediately before and placebo IV over 30 minutes immediately after oxaliplatin administration (part of FOLFOX chemotherapy).>> >> calcium gluconate: Given IV>> >> magnesium sulfate: Given IV>> >> placebo: Given IV>> >> oxaliplatin
Measure Participants	118	119	116
Number [Number of reported Adverse Events]	290	259	296

10. Secondary Outcome

Title	Area Under the Curve (AUC) of Patient-reported Quality of Life (QOL) as Measured by the Supplemental QOL Questionnaire
Description	This is a multivariate repeated measurement of CIPN with possibly variable cycles for every patient. The supplemental quality of life (QOL) subscale will be calculated by standard scoring algorithm and converted to 0-100 scale, where higher scores represent a higher quality of life. Rather than choosing the subscale at a fixed cycle of chemotherapy, we will adopt a summary measure, area under the curve (AUC) . This AUC will be prorated by the number of chemotherapy cycles patients received.
Time Frame	Up to 18 months

Outcome Measure Data

Analysis Population Description
All patients that had at least one cycle of treatment and submitted a patient-reported quality of life (QOL) as measured by the supplemental QOL questionnaire

Arm/Group Title	Arm I	Arm II	Arm III
Arm/Group Description	Patients receive calcium gluconate and magnesium sulfate IV over 30 minutes immediately before and after oxaliplatin administration (part of FOLFOX chemotherapy comprising leucovorin calcium, fluorouracil, and oxaliplatin).> >> > >> calcium gluconate: Given IV> >> > >> magnesium sulfate: Given IV> >> > >> oxaliplatin	Patients receive placebo IV over 30 minutes immediately before and after oxaliplatin administration (part of FOLFOX chemotherapy).> >> > >> placebo: Given IV> >> > >> oxaliplatin	Patients receive calcium gluconate and magnesium sulfate IV over 30 minutes immediately before and placebo IV over 30 minutes immediately after oxaliplatin administration (part of FOLFOX chemotherapy).> >> > >> calcium gluconate: Given IV> >> > >> magnesium sulfate: Given IV> >> > >> placebo: Given IV> >> > >> oxaliplatin
Measure Participants	111	112	108
Diarrhea	86.7 (15.5)	86.2 (15.7)	84.5 (16)
Constipation	90.1 (13.0)	88.8 (13.4)	88.0 (18.8)
Stomach Cramping	92.8 (11.4)	90.6 (12.6)	89.4 (15.6)
Bowel Problems	89.1 (13.4)	88.5 (14.4)	84.6 (19.0)
Swallowing	91.2 (10.0)	87.6 (13.8)	86.7 (14.1)
Numbness in finger and toes	83.4 (14.8)	81.8 (15.7)	80.0 (17.3)
Tingling in finger and toes	78.9 (16.5)	76.5 (17.3)	76.3 (17.6)

Adverse Events

	Calcium Gluconate + Magnesium Sulfate (Pre and Post)		Placebo (Pre and Post)		Calcium Gluconate + Magnesium Sulfate (Pre), Placebo (Post)
Time Frame	3 years
Adverse Event Reporting Description	This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 for adverse event monitoring and reporting. The CTCAE version 4.0 can be accessed from the CTEP home page (http://ctep.cancer.gov).

Arm/Group Title	Calcium Gluconate + Magnesium Sulfate (Pre and Post)		Placebo (Pre and Post)		Calcium Gluconate + Magnesium Sulfate (Pre), Placebo (Post)
Arm/Group Description	oxaliplatin		oxaliplatin		oxaliplatin
All Cause Mortality
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Calcium Gluconate + Magnesium Sulfate (Pre and Post)		Placebo (Pre and Post)		Calcium Gluconate + Magnesium Sulfate (Pre), Placebo (Post)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	13/117 (11.1%)		9/119 (7.6%)		8/116 (6.9%)
Blood and lymphatic system disorders
Febrile neutropenia	1/117 (0.9%)	1	1/119 (0.8%)	1	0/116 (0%)	0
Cardiac disorders
Atrial flutter	0/117 (0%)	0	0/119 (0%)	0	1/116 (0.9%)	1
Gastrointestinal disorders
Abdominal pain	0/117 (0%)	0	0/119 (0%)	0	1/116 (0.9%)	1
Constipation	0/117 (0%)	0	0/119 (0%)	0	1/116 (0.9%)	1
Diarrhea	9/117 (7.7%)	13	3/119 (2.5%)	3	3/116 (2.6%)	3
Nausea	3/117 (2.6%)	5	0/119 (0%)	0	3/116 (2.6%)	6
Small intestinal obstruction	0/117 (0%)	0	0/119 (0%)	0	1/116 (0.9%)	1
Vomiting	1/117 (0.9%)	1	0/119 (0%)	0	1/116 (0.9%)	1
General disorders
Fatigue	0/117 (0%)	0	0/119 (0%)	0	1/116 (0.9%)	1
Fever	1/117 (0.9%)	2	0/119 (0%)	0	0/116 (0%)	0
Infections and infestations
Abdominal infection	1/117 (0.9%)	1	0/119 (0%)	0	0/116 (0%)	0
Bronchial infection	0/117 (0%)	0	1/119 (0.8%)	1	0/116 (0%)	0
Urinary tract infection	1/117 (0.9%)	1	0/119 (0%)	0	0/116 (0%)	0
Injury, poisoning and procedural complications
Infusion related reaction	2/117 (1.7%)	2	0/119 (0%)	0	0/116 (0%)	0
Investigations
Alkaline phosphatase increased	0/117 (0%)	0	1/119 (0.8%)	1	0/116 (0%)	0
Neutrophil count decreased	0/117 (0%)	0	3/119 (2.5%)	4	1/116 (0.9%)	1
Platelet count decreased	1/117 (0.9%)	1	0/119 (0%)	0	0/116 (0%)	0
Metabolism and nutrition disorders
Hypokalemia	0/117 (0%)	0	0/119 (0%)	0	1/116 (0.9%)	1
Nervous system disorders
Peripheral sensory neuropathy	0/117 (0%)	0	1/119 (0.8%)	1	0/116 (0%)	0
Transient ischemic attacks	0/117 (0%)	0	1/119 (0.8%)	1	0/116 (0%)	0
Psychiatric disorders
Anxiety	0/117 (0%)	0	1/119 (0.8%)	5	0/116 (0%)	0
Respiratory, thoracic and mediastinal disorders
Pneumonitis	0/117 (0%)	0	1/119 (0.8%)	1	0/116 (0%)	0
Other (Not Including Serious) Adverse Events
	Calcium Gluconate + Magnesium Sulfate (Pre and Post)		Placebo (Pre and Post)		Calcium Gluconate + Magnesium Sulfate (Pre), Placebo (Post)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	107/117 (91.5%)		108/119 (90.8%)		105/116 (90.5%)
Blood and lymphatic system disorders
Anemia	1/117 (0.9%)	4	2/119 (1.7%)	7	4/116 (3.4%)	6
Disseminated intravascular coagulation	0/117 (0%)	0	1/119 (0.8%)	1	0/116 (0%)	0
Febrile neutropenia	2/117 (1.7%)	3	4/119 (3.4%)	4	4/116 (3.4%)	4
Thrombotic thrombocytopenic purpura	0/117 (0%)	0	0/119 (0%)	0	2/116 (1.7%)	2
Cardiac disorders
Acute coronary syndrome	0/117 (0%)	0	0/119 (0%)	0	1/116 (0.9%)	1
Atrial fibrillation	0/117 (0%)	0	0/119 (0%)	0	1/116 (0.9%)	1
Sick sinus syndrome	0/117 (0%)	0	1/119 (0.8%)	3	0/116 (0%)	0
Supraventricular tachycardia	0/117 (0%)	0	0/119 (0%)	0	1/116 (0.9%)	1
Ventricular tachycardia	1/117 (0.9%)	1	0/119 (0%)	0	0/116 (0%)	0
Ear and labyrinth disorders
Vertigo	0/117 (0%)	0	0/119 (0%)	0	1/116 (0.9%)	1
Eye disorders
Blurred vision	1/117 (0.9%)	1	0/119 (0%)	0	0/116 (0%)	0
Cataract	1/117 (0.9%)	2	0/119 (0%)	0	0/116 (0%)	0
Eye disorders - Other, specify	0/117 (0%)	0	0/119 (0%)	0	1/116 (0.9%)	1
Gastrointestinal disorders
Abdominal pain	2/117 (1.7%)	3	3/119 (2.5%)	14	2/116 (1.7%)	4
Colitis	0/117 (0%)	0	1/119 (0.8%)	1	0/116 (0%)	0
Colonic obstruction	1/117 (0.9%)	1	0/119 (0%)	0	0/116 (0%)	0
Constipation	3/117 (2.6%)	5	4/119 (3.4%)	8	4/116 (3.4%)	6
Diarrhea	80/117 (68.4%)	315	73/119 (61.3%)	325	77/116 (66.4%)	363
Dysphagia	0/117 (0%)	0	1/119 (0.8%)	1	0/116 (0%)	0
Enterocolitis	1/117 (0.9%)	1	0/119 (0%)	0	1/116 (0.9%)	1
Esophagitis	0/117 (0%)	0	0/119 (0%)	0	1/116 (0.9%)	1
Flatulence	0/117 (0%)	0	0/119 (0%)	0	1/116 (0.9%)	1
Gastritis	0/117 (0%)	0	1/119 (0.8%)	1	0/116 (0%)	0
Gastroesophageal reflux disease	0/117 (0%)	0	1/119 (0.8%)	1	0/116 (0%)	0
Gastrointestinal disorders - Oth spec	0/117 (0%)	0	0/119 (0%)	0	1/116 (0.9%)	1
Gastrointestinal pain	0/117 (0%)	0	1/119 (0.8%)	1	0/116 (0%)	0
Hemorrhoidal hemorrhage	0/117 (0%)	0	0/119 (0%)	0	1/116 (0.9%)	1
Ileal obstruction	0/117 (0%)	0	1/119 (0.8%)	1	0/116 (0%)	0
Lower gastrointestinal hemorrhage	1/117 (0.9%)	1	0/119 (0%)	0	0/116 (0%)	0
Mucositis oral	2/117 (1.7%)	2	5/119 (4.2%)	5	4/116 (3.4%)	5
Nausea	86/117 (73.5%)	351	78/119 (65.5%)	346	78/116 (67.2%)	377
Pancreatitis	1/117 (0.9%)	1	0/119 (0%)	0	0/116 (0%)	0
Rectal mucositis	0/117 (0%)	0	1/119 (0.8%)	1	0/116 (0%)	0
Rectal pain	1/117 (0.9%)	1	0/119 (0%)	0	0/116 (0%)	0
Small intestinal obstruction	1/117 (0.9%)	1	0/119 (0%)	0	1/116 (0.9%)	1
Typhlitis	0/117 (0%)	0	1/119 (0.8%)	1	0/116 (0%)	0
Vomiting	42/117 (35.9%)	70	30/119 (25.2%)	55	33/116 (28.4%)	84
General disorders
Fatigue	9/117 (7.7%)	22	13/119 (10.9%)	32	13/116 (11.2%)	30
Fever	1/117 (0.9%)	1	0/119 (0%)	0	0/116 (0%)	0
Non-cardiac chest pain	1/117 (0.9%)	1	0/119 (0%)	0	0/116 (0%)	0
Pain	0/117 (0%)	0	2/119 (1.7%)	2	0/116 (0%)	0
Immune system disorders
Allergic reaction	0/117 (0%)	0	1/119 (0.8%)	1	0/116 (0%)	0
Infections and infestations
Abdominal infection	1/117 (0.9%)	2	1/119 (0.8%)	1	0/116 (0%)	0
Anorectal infection	1/117 (0.9%)	1	0/119 (0%)	0	0/116 (0%)	0
Bladder infection	1/117 (0.9%)	1	1/119 (0.8%)	1	0/116 (0%)	0
Bronchial infection	0/117 (0%)	0	1/119 (0.8%)	1	0/116 (0%)	0
Bronchitis(unknown ANC)	1/117 (0.9%)	1	0/119 (0%)	0	0/116 (0%)	0
Catheter related infection	0/117 (0%)	0	0/119 (0%)	0	1/116 (0.9%)	1
Enterocolitis infectious	0/117 (0%)	0	0/119 (0%)	0	1/116 (0.9%)	1
Infections and infestations - Oth spec	1/117 (0.9%)	2	0/119 (0%)	0	0/116 (0%)	0
Lung infection	0/117 (0%)	0	1/119 (0.8%)	1	0/116 (0%)	0
Mucosal infection	0/117 (0%)	0	0/119 (0%)	0	1/116 (0.9%)	1
Otitis media	1/117 (0.9%)	1	0/119 (0%)	0	0/116 (0%)	0
Sepsis	0/117 (0%)	0	1/119 (0.8%)	1	0/116 (0%)	0
Skin infection	0/117 (0%)	0	0/119 (0%)	0	1/116 (0.9%)	1
Soft tissue infection	0/117 (0%)	0	1/119 (0.8%)	1	0/116 (0%)	0
Upper respiratory infection	1/117 (0.9%)	1	1/119 (0.8%)	1	0/116 (0%)	0
Urinary tract infection	0/117 (0%)	0	4/119 (3.4%)	5	0/116 (0%)	0
Wound infection	1/117 (0.9%)	1	0/119 (0%)	0	0/116 (0%)	0
Injury, poisoning and procedural complications
Infusion related reaction	1/117 (0.9%)	1	2/119 (1.7%)	2	1/116 (0.9%)	1
Investigations
Alanine aminotransferase increased	2/117 (1.7%)	2	1/119 (0.8%)	1	1/116 (0.9%)	1
Alkaline phosphatase increased	1/117 (0.9%)	2	2/119 (1.7%)	9	0/116 (0%)	0
Aspartate aminotransferase increased	2/117 (1.7%)	2	1/119 (0.8%)	2	0/116 (0%)	0
Creatinine increased	1/117 (0.9%)	1	0/119 (0%)	0	0/116 (0%)	0
Hemoglobin increased	1/117 (0.9%)	1	0/119 (0%)	0	0/116 (0%)	0
INR increased	1/117 (0.9%)	9	1/119 (0.8%)	1	0/116 (0%)	0
Lipase increased	1/117 (0.9%)	1	0/119 (0%)	0	0/116 (0%)	0
Lymphocyte count decreased	2/117 (1.7%)	2	2/119 (1.7%)	3	2/116 (1.7%)	2
Neutrophil count decreased	28/117 (23.9%)	54	28/119 (23.5%)	51	32/116 (27.6%)	67
Platelet count decreased	8/117 (6.8%)	18	8/119 (6.7%)	15	8/116 (6.9%)	16
Weight gain	1/117 (0.9%)	2	0/119 (0%)	0	0/116 (0%)	0
White blood cell decreased	13/117 (11.1%)	20	10/119 (8.4%)	17	14/116 (12.1%)	21
Metabolism and nutrition disorders
Anorexia	2/117 (1.7%)	2	2/119 (1.7%)	2	1/116 (0.9%)	1
Dehydration	2/117 (1.7%)	2	5/119 (4.2%)	5	3/116 (2.6%)	3
Hyperglycemia	3/117 (2.6%)	5	2/119 (1.7%)	2	1/116 (0.9%)	2
Hyperkalemia	0/117 (0%)	0	0/119 (0%)	0	2/116 (1.7%)	2
Hypernatremia	0/117 (0%)	0	0/119 (0%)	0	1/116 (0.9%)	1
Hypertriglyceridemia	0/117 (0%)	0	0/119 (0%)	0	1/116 (0.9%)	3
Hypoalbuminemia	0/117 (0%)	0	1/119 (0.8%)	1	1/116 (0.9%)	1
Hypocalcemia	0/117 (0%)	0	0/119 (0%)	0	2/116 (1.7%)	2
Hypoglycemia	0/117 (0%)	0	1/119 (0.8%)	1	0/116 (0%)	0
Hypokalemia	3/117 (2.6%)	3	4/119 (3.4%)	4	2/116 (1.7%)	3
Hyponatremia	1/117 (0.9%)	5	1/119 (0.8%)	1	1/116 (0.9%)	1
Hypophosphatemia	0/117 (0%)	0	2/119 (1.7%)	2	0/116 (0%)	0
Musculoskeletal and connective tissue disorders
Arthralgia	0/117 (0%)	0	1/119 (0.8%)	1	0/116 (0%)	0
Generalized muscle weakness	2/117 (1.7%)	3	0/119 (0%)	0	0/116 (0%)	0
Joint range of motion decreased	1/117 (0.9%)	2	0/119 (0%)	0	0/116 (0%)	0
Neck pain	0/117 (0%)	0	1/119 (0.8%)	1	0/116 (0%)	0
Pain in extremity	0/117 (0%)	0	1/119 (0.8%)	1	1/116 (0.9%)	1
Nervous system disorders
Ataxia	1/117 (0.9%)	1	0/119 (0%)	0	0/116 (0%)	0
Cognitive disturbance	1/117 (0.9%)	1	0/119 (0%)	0	0/116 (0%)	0
Dizziness	2/117 (1.7%)	3	0/119 (0%)	0	1/116 (0.9%)	1
Dysesthesia	0/117 (0%)	0	0/119 (0%)	0	1/116 (0.9%)	1
Dysgeusia	1/117 (0.9%)	1	0/119 (0%)	0	0/116 (0%)	0
Headache	0/117 (0%)	0	1/119 (0.8%)	1	0/116 (0%)	0
Paresthesia	0/117 (0%)	0	2/119 (1.7%)	3	1/116 (0.9%)	1
Peripheral motor neuropathy	2/117 (1.7%)	2	2/119 (1.7%)	3	2/116 (1.7%)	2
Peripheral sensory neuropathy	14/117 (12%)	33	12/119 (10.1%)	23	10/116 (8.6%)	18
Stroke	0/117 (0%)	0	1/119 (0.8%)	1	0/116 (0%)	0
Tremor	1/117 (0.9%)	2	0/119 (0%)	0	0/116 (0%)	0
Psychiatric disorders
Anxiety	1/117 (0.9%)	2	1/119 (0.8%)	2	0/116 (0%)	0
Depression	0/117 (0%)	0	0/119 (0%)	0	1/116 (0.9%)	1
Insomnia	1/117 (0.9%)	1	2/119 (1.7%)	2	1/116 (0.9%)	4
Renal and urinary disorders
Chronic kidney disease	1/117 (0.9%)	2	0/119 (0%)	0	0/116 (0%)	0
Hematuria	0/117 (0%)	0	2/119 (1.7%)	2	0/116 (0%)	0
Proteinuria	0/117 (0%)	0	1/119 (0.8%)	1	0/116 (0%)	0
Renal and urinary disorders - Oth spec	0/117 (0%)	0	0/119 (0%)	0	1/116 (0.9%)	2
Respiratory, thoracic and mediastinal disorders
Bronchial stricture	0/117 (0%)	0	1/119 (0.8%)	1	0/116 (0%)	0
Cough	1/117 (0.9%)	1	1/119 (0.8%)	1	0/116 (0%)	0
Dyspnea	0/117 (0%)	0	2/119 (1.7%)	2	0/116 (0%)	0
Laryngopharyngeal dysesthesia	0/117 (0%)	0	0/119 (0%)	0	2/116 (1.7%)	2
Pharyngeal mucositis	0/117 (0%)	0	1/119 (0.8%)	1	0/116 (0%)	0
Pneumonitis	0/117 (0%)	0	0/119 (0%)	0	1/116 (0.9%)	1
Productive cough	0/117 (0%)	0	1/119 (0.8%)	1	0/116 (0%)	0
Respiratory failure	1/117 (0.9%)	1	0/119 (0%)	0	0/116 (0%)	0
Wheezing	0/117 (0%)	0	1/119 (0.8%)	1	0/116 (0%)	0
Skin and subcutaneous tissue disorders
Alopecia	0/117 (0%)	0	0/119 (0%)	0	1/116 (0.9%)	1
Palmar-plantar erythrodysesthesia syndrm	1/117 (0.9%)	3	0/119 (0%)	0	2/116 (1.7%)	3
Pruritus	0/117 (0%)	0	1/119 (0.8%)	1	0/116 (0%)	0
Skin and subcut tissue disord - Oth spec	1/117 (0.9%)	2	1/119 (0.8%)	1	0/116 (0%)	0
Surgical and medical procedures
Surgical and medical proced - Oth spec	1/117 (0.9%)	2	0/119 (0%)	0	0/116 (0%)	0
Vascular disorders
Flushing	0/117 (0%)	0	1/119 (0.8%)	1	0/116 (0%)	0
Hot flashes	0/117 (0%)	0	1/119 (0.8%)	3	0/116 (0%)	0
Hypertension	2/117 (1.7%)	8	3/119 (2.5%)	4	2/116 (1.7%)	9
Hypotension	2/117 (1.7%)	2	3/119 (2.5%)	3	2/116 (1.7%)	2
Superficial thrombophlebitis	1/117 (0.9%)	1	0/119 (0%)	0	0/116 (0%)	0
Thromboembolic event	4/117 (3.4%)	14	3/119 (2.5%)	4	5/116 (4.3%)	10
Vascular disorders - Other, specify	0/117 (0%)	0	1/119 (0.8%)	1	0/116 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Name/Title	Charles Loprinzi, M.D.
Organization	Mayo Clinic
Phone	(507) 284-3731
Email	cloprinzi@mayo.edu

Responsible Party:

Alliance for Clinical Trials in Oncology

ClinicalTrials.gov Identifier:

NCT01099449

Other Study ID Numbers:

N08CB
NCCTG-N08CB
CDR0000669660
NCI-2011-02036

First Posted:

Apr 7, 2010

Last Update Posted:

May 23, 2019

Last Verified:

May 1, 2019

Calcium Gluconate and Magnesium Sulfate in Preventing Neurotoxicity in Patients With Colon Cancer or Rectal Cancer Receiving Oxaliplatin-Based Combination Chemotherapy

Study Details

Study Description

Brief Summary

Detailed Description

OBJECTIVES:

Study Design

Arms and Interventions

Outcome Measures

Primary Outcome Measures

Secondary Outcome Measures

Eligibility Criteria

Criteria

DISEASE CHARACTERISTICS:

PATIENT CHARACTERISTICS:

PRIOR CONCURRENT THERAPY:

Contacts and Locations

Locations

Sponsors and Collaborators

Investigators

Study Documents (Full-Text)

More Information

Publications

Study Results

Participant Flow

Baseline Characteristics

Outcome Measures

Outcome Measure Data

Statistical Analysis 1

Statistical Analysis 2

Outcome Measure Data

Statistical Analysis 1

Statistical Analysis 2

Outcome Measure Data

Statistical Analysis 1

Statistical Analysis 2

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Statistical Analysis 1

Statistical Analysis 2

Outcome Measure Data

Statistical Analysis 1

Statistical Analysis 2

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Adverse Events

All Cause Mortality

Serious Adverse Events

Other (Not Including Serious) Adverse Events

Limitations/Caveats

More Information

Certain Agreements

Results Point of Contact