Doxorubicin Hydrochloride, Cisplatin, and Paclitaxel or Carboplatin and Paclitaxel in Treating Patients With Stage III-IV or Recurrent Endometrial Cancer

• Sponsor: GOG Foundation (Other)
• Overall Status: Completed
• CT.gov ID: NCT00063999
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 1,381
• Locations: 650
• Arms: 2
• Actual Duration (Months): 208.4
• Patients Per Site: 2.1
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

This randomized phase III trial compares how well two different combination chemotherapy regimens (doxorubicin hydrochloride, cisplatin, and paclitaxel versus carboplatin and paclitaxel) work in treating patients with endometrial cancer that is stage III-IV or has come back (recurrent). Drugs used in chemotherapy such as doxorubicin hydrochloride, cisplatin, paclitaxel, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known which combination chemotherapy regimen is more effective in treating endometrial cancer.

Condition or Disease	Intervention/Treatment	Phase
Recurrent Uterine Corpus Carcinoma; Stage IIIA Uterine Corpus Cancer AJCC v7; Stage IIIB Uterine Corpus Cancer AJCC v7; Stage IIIC Uterine Corpus Cancer AJCC v7; Stage IVA Uterine Corpus Cancer AJCC v7; Stage IVB Uterine Corpus Cancer AJCC v7	Drug: Carboplatin; Drug: Cisplatin; Drug: Doxorubicin Hydrochloride; Biological: Filgrastim; Other: Laboratory Biomarker Analysis; Drug: Paclitaxel; Biological: Pegfilgrastim; Other: Quality-of-Life Assessment	Phase 3

Detailed Description

PRIMARY OBJECTIVES:

1. To determine if the combination of carboplatin and paclitaxel (TC) chemotherapy is therapeutically equivalent to the combination of doxorubicin (doxorubicin hydrochloride), cisplatin and paclitaxel (TAP) chemotherapy with regards to survival.

2. To determine if estrogen/progesterone receptor status provides prognostic information in patients treated with chemotherapy.

3. To assess whether combination TC chemotherapy is superior to combination TAP chemotherapy with regards to toxicity profile, specifically neurotoxicity and infection.

4. To measure differences in patient-reported neurotoxicity and quality of life (QOL) among the regimens.

OUTLINE: Patients are randomized to 1 of 2 treatment arms. Patients with left ventricular ejection fraction < 50% at randomization who are initially randomized to Arm I are immediately crossed over to Arm II.

ARM I: Patients receive doxorubicin hydrochloride intravenously (IV) over approximately 15-30 minutes on day 1, cisplatin IV over 60-90 minutes on day 1, paclitaxel IV over 3 hours on day 2, and filgrastim subcutaneously (SC) on days 3-12 or pegfilgrastim SC on day 3.

ARM II: Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30-60 minutes on day 1.

In both arms, treatment repeats every 21 days for 7 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

Study Design

• Study Type: Interventional
• Actual Enrollment: 1381 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Randomized Phase III Trial of Doxorubicin/Cisplatin/Paclitaxel and G-CSF Versus Carboplatin/Paclitaxel in Patients With Stage III &Amp; IV or Recurrent Endometrial Cancer
• Actual Study Start Date: Aug 25, 2003
• Actual Primary Completion Date: Jun 29, 2013
• Actual Study Completion Date: Jan 5, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Arm I (doxorubicin hydrochloride, cisplatin, paclitaxel) Patients receive doxorubicin hydrochloride IV over approximately 15-30 minutes on day 1, cisplatin IV over 60-90 minutes on day 1, paclitaxel IV over 3 hours on day 2, and filgrastim SC on days 3-12 or pegfilgrastim SC on day 3. Treatment repeats every 21 days for 7 courses in the absence of disease progression or unacceptable toxicity.	Drug: Cisplatin; Given IV; Other Names: Abiplatin Blastolem Briplatin CDDP Cis-diammine-dichloroplatinum Cis-diamminedichloridoplatinum Cis-diamminedichloro Platinum (II) Cis-diamminedichloroplatinum Cis-dichloroammine Platinum (II) Cis-platinous Diamine Dichloride Cis-platinum Cis-platinum II Cis-platinum II Diamine Dichloride Cismaplat Cisplatina Cisplatinum Cisplatyl Citoplatino Citosin Cysplatyna DDP Lederplatin Metaplatin Neoplatin Peyrone's Chloride Peyrone's Salt Placis Plastistil Platamine Platiblastin Platiblastin-S Platinex Platinol Platinol- AQ Platinol-AQ Platinol-AQ VHA Plus Platinoxan Platinum Platinum Diamminodichloride Platiran Platistin Platosin ; Drug: Doxorubicin Hydrochloride; Given IV; Other Names: 5,12-Naphthacenedione, 10-[(3-amino-2,3,6-trideoxy-alpha-L-lyxo-hexopyranosyl)oxy]-7,8, 9,10-tetrahydro-6,8,11-trihydroxy-8-(hydroxyacetyl)-1-methoxy-, hydrochloride, (8S-cis)- (9CI) ADM Adriacin Adriamycin Adriamycin Hydrochloride Adriamycin PFS Adriamycin RDF ADRIAMYCIN, HYDROCHLORIDE Adriamycine Adriblastina Adriblastine Adrimedac Chloridrato de Doxorrubicina DOX DOXO-CELL Doxolem Doxorubicin.HCl Doxorubin Farmiblastina FI 106 FI-106 hydroxydaunorubicin Rubex ; Biological: Filgrastim; Given SC; Other Names: FILGRASTIM, LICENSE HOLDER UNSPECIFIED G-CSF Neupogen r-metHuG-CSF Recombinant Methionyl Human Granulocyte Colony Stimulating Factor rG-CSF Tevagrastim ; Other: Laboratory Biomarker Analysis; Correlative studies; Drug: Paclitaxel; Given IV; Other Names: Anzatax Asotax Bristaxol Praxel Taxol Taxol Konzentrat ; Biological: Pegfilgrastim; Given SC; Other Names: Filgrastim SD-01 filgrastim-SD/01 Fulphila HSP-130 Jinyouli Neulasta Neulastim Pegfilgrastim Biosimilar HSP-130 SD-01 SD-01 sustained duration G-CSF ; Other: Quality-of-Life Assessment; Ancillary studies; Other Names: Quality of Life Assessment
Experimental: Arm II (paclitaxel, carboplatin) Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for 7 courses in the absence of disease progression or unacceptable toxicity.	Drug: Carboplatin; Given IV; Other Names: Blastocarb Carboplat Carboplatin Hexal Carboplatino Carbosin Carbosol Carbotec CBDCA Displata Ercar JM-8 Nealorin Novoplatinum Paraplatin Paraplatin AQ Paraplatine Platinwas Ribocarbo ; Other: Laboratory Biomarker Analysis; Correlative studies; Drug: Paclitaxel; Given IV; Other Names: Anzatax Asotax Bristaxol Praxel Taxol Taxol Konzentrat ; Other: Quality-of-Life Assessment; Ancillary studies; Other Names: Quality of Life Assessment

Outcome Measures

Primary Outcome Measures

1. Number of Participants Alive at Time of Last Follow-up. [Patients were assessed during treatment. Following completion of treatment, follow up was assessed every 3 months for 2 years, then every 6 months for 3 years and annually after for a maximum of 10 years.]

   The time alive in months from study entry to last contact or death.

Secondary Outcome Measures

1. Patient-reported Neurotoxicity (Ntx) as Measured by the FACT/GOG-Ntx Subscale (Short) [Baseline, 6 weeks post treatment start, 15 weeks post treatment start and 26 weeks post treatment start]

   The FACT/GOG-Ntx subscale (short version) contains 4 items measuring sensory neuropathy. Each item is scored using a 5-point Likert scale (0=not at all; 1= a little bit; 2=somewhat; 3=quite a bit; 4=very much). For east item, reversal was performed prior to score calculation so that a large score suggests less symptom. according to the FACIT measurement system, the subscale score was calculated as the summation of the individual item scores if more than 50% of subscale items were answered. When unanswered items existed, a subscale score was prorated by multiplying the mean of the answered item scores by the number of items in the subscale. The Ntx subscale score ranges 0-16 with a large subscale score suggests less symptom or better QOL (Quality of Life).

2. Patient Reported Quality of Life as Measured With the Combination of Physical Well-being (PWB) Subscale and Functional Well-being (FWB) Subscale From the FACT-G [Pre-treatment, 6 weeks post starting treatment (prior to cycle 3), 15 weeks post starting treatment (prior to cycle 6), 26 weeks post starting treatment]

   The FACT-G contains 4 subscales: Physical Well Being (7 items), Social Well Being (7 items), Emotional Well Being (6 items), Functional Well Being (7 items). The combination (14 items) of the physical well-being (PWB) and functional well-being (FWB) subscales was used to measure the HRQOL (Health Related Quality of Life). Each item is scored using a 5-point Likert scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). for each negative item, reversal was performed prior to score calculation so that a large score suggests better QOL. A subscale score was calculated as the summation of the individual item scores if more than 50% of subscale items were answered. When unanswered items existed, a subscale score was prorated by multiplying the mean of the answred item scores by the number of items in the subscale. The QOL was measured with the summation of the PWB and FWBsubscale score and ranges 0-56 with a large score suggests better QOL.

3. Number of Participants Alive at Time of Last Follow-up by Estrogen or Progesterone Receptor Status (Positive or Negative) [Patients were assessed during treatment. Following completion of treatment, follow up was assessed every 3 months for 2 years, then every 6 months for 3 years and annually thereafter, for a maximum of 10 years.]

   The time alive in months from study entry to last contact or death.

4. Number of Participants With Indicated Severity of CTCAE v2 Graded Neurotoxicity and Infection [Assessed throughout the treatment period and for 30 days after discontinuation of treatment.]

   Maximum grade of physician assessed neurotoxicity and infection

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients must have primary stage III or stage IV or recurrent endometrial carcinoma whose potential for cure by radiation therapy or surgery alone or in combination is very poor; pathological confirmation and estrogen receptor (ER)/progesterone receptor (PR) status of the primary tumor is mandatory; however, the results do not need to be available prior to registration

• Patients may not have received prior cytotoxic chemotherapy, including chemotherapy used for radiation sensitization; patients may have received prior radiation therapy, hormonal therapy, or therapy with biologic agents, but such therapies must be discontinued prior to entry on this study

• Patients in whom both radiation and chemotherapy is planned must receive radiation prior to entry on this study; at least four weeks should have elapsed since completion of radiation therapy (RT) involving the whole pelvis or over 50% of the spine

• Platelets >= 100,000/mcl

• Granulocytes (absolute neutrophil count [ANC]) >= 1,500/mcl

• Creatinine =< upper limit of normal (ULN) (Common Toxicity Criteria [CTC] grade 0) or calculated creatinine clearance (Jeliffe Formula) >= 60 ml/min

• Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =< 3 x upper limits of normal

• Bilirubin =< institutional upper limits of normal

• Patients must have a Gynecologic Oncology Group (GOG) performance status of 0, 1, or 2

• Patients must have met the pre-entry requirements

• Patients must have signed an approved informed consent and authorization permitting release of personal health information

Exclusion Criteria:

• Patients with a concomitant malignancy other than non-melanoma skin cancer; with the exception of non-melanoma skin cancer, patients with a prior invasive malignancy who have been disease-free for < 5 years or who received prior chemotherapy for that malignancy

• Patients in whom pathological confirmation and estrogen receptor (ER)/progesterone receptor (PR) status of the tumor is not obtainable

• Patients for whom radiation therapy is planned during or after study chemotherapy prior to demonstrated progression

• Patients with concomitant medical illness such as serious uncontrolled infection, uncontrolled angina, or serious peripheral neuropathy, which, in the opinion of the treating physician, make the treatments prescribed on this study unreasonably hazardous for the patient

• Patients with third degree or complete heart block are not eligible unless a pacemaker is in place; patients on medications which alter cardiac conduction, such as digitalis, beta-blockers, or calcium channel blockers, or who have other conduction abnormalities or cardiac dysfunction may be placed on study at the discretion of the investigator

• Patients with history of myocardial infarct within 6 months before enrollment, New York Heart Association (NYHA) class II or greater heart failure or symptoms suspicious for congestive heart failure are not eligible unless a left ventricular ejection fraction in the past 6 months is documented to be 50% or greater; patients who have had a left ventricular ejection fraction (LVEF) (performed for any reason) of less than 50% in the past 6 months are ineligible

• Patients whose circumstances will not permit study completion or adequate follow-up

• Patients who are sensitive to E. coli-derived drug preparations

• Patients with uterine carcinosarcoma or other non-epithelial uterine malignancies

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama at Birmingham Cancer Center	Birmingham	Alabama	United States	35233
2	Clearview Cancer Institute	Huntsville	Alabama	United States	35805
3	Mobile Infirmary Medical Center	Mobile	Alabama	United States	36607
4	Providence Hospital	Mobile	Alabama	United States	36608
5	Providence Alaska Medical Center	Anchorage	Alaska	United States	99508
6	Mayo Clinic in Arizona	Scottsdale	Arizona	United States	85259
7	Highlands Oncology Group PA - Fayetteville	Fayetteville	Arkansas	United States	72703
8	Washington Regional Medical Center - Fayetteville	Fayetteville	Arkansas	United States	72703
9	University of Arkansas for Medical Sciences	Little Rock	Arkansas	United States	72205
10	Providence Saint Joseph Medical Center/Disney Family Cancer Center	Burbank	California	United States	91505
11	John Muir Medical Center-Concord Campus	Concord	California	United States	94520
12	City of Hope Comprehensive Cancer Center	Duarte	California	United States	91010
13	Kaiser Permanente-Fremont	Fremont	California	United States	94538
14	Saint Jude Medical Center	Fullerton	California	United States	92835
15	Marin Cancer Care Inc	Greenbrae	California	United States	94904
16	Long Beach Memorial Medical Center-Todd Cancer Institute	Long Beach	California	United States	90806
17	Kaiser Permanente Los Angeles Medical Center	Los Angeles	California	United States	90027
18	USC / Norris Comprehensive Cancer Center	Los Angeles	California	United States	90033
19	Cedars Sinai Medical Center	Los Angeles	California	United States	90048
20	UCLA / Jonsson Comprehensive Cancer Center	Los Angeles	California	United States	90095
21	Community Hospital of Los Gatos	Los Gatos	California	United States	95032
22	Doctors Medical Center	Modesto	California	United States	95350
23	Memorial Medical Center	Modesto	California	United States	95355
24	Kaiser Permanente-Oakland	Oakland	California	United States	94611
25	UC Irvine Health/Chao Family Comprehensive Cancer Center	Orange	California	United States	92868
26	Stanford Cancer Institute Palo Alto	Palo Alto	California	United States	94304
27	Kaiser Permanente-Redwood City	Redwood City	California	United States	94063
28	Kaiser Permanente-Richmond	Richmond	California	United States	94801
29	Kaiser Permanente-Roseville	Roseville	California	United States	95661
30	Sutter Roseville Medical Center	Roseville	California	United States	95661
31	Sutter Medical Center Sacramento	Sacramento	California	United States	95816
32	University of California Davis Comprehensive Cancer Center	Sacramento	California	United States	95817
33	Kaiser Permanente-South Sacramento	Sacramento	California	United States	95823
34	Kaiser Permanente - Sacramento	Sacramento	California	United States	95825
35	Salinas Valley Memorial	Salinas	California	United States	93901
36	University of California San Diego	San Diego	California	United States	92103
37	Alvarado Hospital Medical Center	San Diego	California	United States	92120
38	Zuckerberg San Francisco General Hospital	San Francisco	California	United States	94110
39	Kaiser Permanente-San Francisco	San Francisco	California	United States	94115
40	UCSF Medical Center-Mount Zion	San Francisco	California	United States	94115
41	Kaiser Permanente-Santa Teresa-San Jose	San Jose	California	United States	95119
42	Kaiser Permanente San Leandro	San Leandro	California	United States	94577
43	Kaiser Permanente-San Rafael	San Rafael	California	United States	94903
44	Cancer Center of Santa Barbara	Santa Barbara	California	United States	93105
45	Ridley-Tree Cancer Center	Santa Barbara	California	United States	93105
46	Sansum Clinic Inc	Santa Barbara	California	United States	93105
47	Kaiser Permanente Medical Center - Santa Clara	Santa Clara	California	United States	95051
48	Kaiser Permanente-Santa Rosa	Santa Rosa	California	United States	95403
49	Ridley-Tree Cancer Center-Solvang	Solvang	California	United States	93463
50	Kaiser Permanente-South San Francisco	South San Francisco	California	United States	94080
51	Kaiser Permanente-Stockton	Stockton	California	United States	95210
52	Olive View-University of California Los Angeles Medical Center	Sylmar	California	United States	91342
53	Kaiser Permanente-Vallejo	Vallejo	California	United States	94589
54	Kaiser Permanente-Walnut Creek	Walnut Creek	California	United States	94596
55	John Muir Medical Center-Walnut Creek	Walnut Creek	California	United States	94598
56	Colorado Gynecologic Oncology Group	Aurora	Colorado	United States	80010
57	University of Colorado	Denver	Colorado	United States	80217-3364
58	Rocky Mountain Gynecologic Oncology PC	Englewood	Colorado	United States	80110
59	Poudre Valley Hospital	Fort Collins	Colorado	United States	80524
60	Hartford Hospital	Hartford	Connecticut	United States	06102
61	Smilow Cancer Hospital Care Center at Saint Francis	Hartford	Connecticut	United States	06105
62	The Hospital of Central Connecticut	New Britain	Connecticut	United States	06050
63	Yale University	New Haven	Connecticut	United States	06520
64	Beebe Medical Center	Lewes	Delaware	United States	19958
65	Christiana Care Health System-Christiana Hospital	Newark	Delaware	United States	19718
66	TidalHealth Nanticoke / Allen Cancer Center	Seaford	Delaware	United States	19973
67	Saint Francis Hospital - Wilmington	Wilmington	Delaware	United States	19805
68	MedStar Washington Hospital Center	Washington	District of Columbia	United States	20010
69	Morton Plant Hospital	Clearwater	Florida	United States	33756
70	Broward Health Medical Center	Fort Lauderdale	Florida	United States	33316
71	Florida Gynecologic Oncology	Fort Myers	Florida	United States	33905
72	Saint Vincent's Medical Center	Jacksonville	Florida	United States	32204
73	Mayo Clinic in Florida	Jacksonville	Florida	United States	32224-9980
74	Jupiter Medical Center	Jupiter	Florida	United States	33458
75	Mercy Hospital	Miami	Florida	United States	33133
76	University of Miami Miller School of Medicine-Sylvester Cancer Center	Miami	Florida	United States	33136
77	AdventHealth Orlando	Orlando	Florida	United States	32803
78	Orlando Health Cancer Institute	Orlando	Florida	United States	32806
79	Bayfront Outpatient Health Clinic	Saint Petersburg	Florida	United States	33701
80	Sarasota Memorial Hospital	Sarasota	Florida	United States	34239
81	Moffitt Cancer Center	Tampa	Florida	United States	33612
82	Florida Cancer Specialists-West Palm Beach	West Palm Beach	Florida	United States	33401
83	Southeastern Gynecologic Oncology LLP	Atlanta	Georgia	United States	30033
84	Piedmont Hospital	Atlanta	Georgia	United States	30309
85	Atlanta Regional CCOP	Atlanta	Georgia	United States	30342
86	Emory Saint Joseph's Hospital	Atlanta	Georgia	United States	30342
87	Northside Hospital	Atlanta	Georgia	United States	30342
88	Augusta University Medical Center	Augusta	Georgia	United States	30912
89	WellStar Cobb Hospital	Austell	Georgia	United States	30106
90	John B Amos Cancer Center	Columbus	Georgia	United States	31904
91	Dekalb Medical Center	Decatur	Georgia	United States	30033
92	Northeast Georgia Medical Center-Gainesville	Gainesville	Georgia	United States	30501
93	Northside Hospital - Gwinnett	Lawrenceville	Georgia	United States	30046
94	Central Georgia Gynecologic Oncology	Macon	Georgia	United States	31201
95	Wellstar Kennestone Hospital	Marietta	Georgia	United States	30060
96	Southern Regional Medical Center	Riverdale	Georgia	United States	30274
97	Harbin Clinic Medical Oncology and Clinical Research	Rome	Georgia	United States	30165
98	Memorial Health University Medical Center	Savannah	Georgia	United States	31404
99	Pali Momi Medical Center	'Aiea	Hawaii	United States	96701
100	Hawaii Cancer Care Inc - Waterfront Plaza	Honolulu	Hawaii	United States	96813
101	Queen's Medical Center	Honolulu	Hawaii	United States	96813
102	Straub Clinic and Hospital	Honolulu	Hawaii	United States	96813
103	University of Hawaii Cancer Center	Honolulu	Hawaii	United States	96813
104	Queen's Cancer Center - Kuakini	Honolulu	Hawaii	United States	96817
105	The Cancer Center of Hawaii-Liliha	Honolulu	Hawaii	United States	96817
106	Kapiolani Medical Center for Women and Children	Honolulu	Hawaii	United States	96826
107	Pacific Cancer Institute of Maui	Wailuku	Hawaii	United States	96793
108	Saint Anthony's Health	Alton	Illinois	United States	62002
109	Northwest Community Hospital	Arlington Heights	Illinois	United States	60005
110	Rush - Copley Medical Center	Aurora	Illinois	United States	60504
111	Saint Joseph Medical Center	Bloomington	Illinois	United States	61701
112	Graham Hospital Association	Canton	Illinois	United States	61520
113	Memorial Hospital	Carthage	Illinois	United States	62321
114	Mount Sinai Hospital Medical Center	Chicago	Illinois	United States	60608
115	Northwestern University	Chicago	Illinois	United States	60611
116	Rush University Medical Center	Chicago	Illinois	United States	60612
117	University of Illinois	Chicago	Illinois	United States	60612
118	Swedish Covenant Hospital	Chicago	Illinois	United States	60625
119	University of Chicago Comprehensive Cancer Center	Chicago	Illinois	United States	60637
120	Decatur Memorial Hospital	Decatur	Illinois	United States	62526
121	Heartland Cancer Research NCORP	Decatur	Illinois	United States	62526
122	Eureka Hospital	Eureka	Illinois	United States	61530
123	NorthShore University HealthSystem-Evanston Hospital	Evanston	Illinois	United States	60201
124	Saint Francis Hospital	Evanston	Illinois	United States	60202
125	Galesburg Cottage Hospital	Galesburg	Illinois	United States	61401
126	Illinois CancerCare-Galesburg	Galesburg	Illinois	United States	61401
127	Western Illinois Cancer Treatment Center	Galesburg	Illinois	United States	61401
128	Ingalls Memorial Hospital	Harvey	Illinois	United States	60426
129	Mason District Hospital	Havana	Illinois	United States	62644
130	Hinsdale Hematology Oncology Associates Incorporated	Hinsdale	Illinois	United States	60521
131	Hopedale Medical Complex - Hospital	Hopedale	Illinois	United States	61747
132	Duly Health and Care Joliet	Joliet	Illinois	United States	60435
133	Presence Saint Mary's Hospital	Kankakee	Illinois	United States	60901
134	Kewanee Hospital	Kewanee	Illinois	United States	61443
135	Mcdonough District Hospital	Macomb	Illinois	United States	61455
136	Loyola University Medical Center	Maywood	Illinois	United States	60153
137	Good Samaritan Regional Health Center	Mount Vernon	Illinois	United States	62864
138	Bromenn Regional Medical Center	Normal	Illinois	United States	61761
139	Carle Cancer Institute Normal	Normal	Illinois	United States	61761
140	Franciscan St. James Health-Olympia Fields Campus	Olympia Fields	Illinois	United States	60461
141	Illinois CancerCare-Ottawa Clinic	Ottawa	Illinois	United States	61350
142	Ottawa Regional Hospital and Healthcare Center	Ottawa	Illinois	United States	61350
143	Chicago Gynecologic Oncology SC	Palatine	Illinois	United States	60067
144	Advocate Lutheran General Hospital	Park Ridge	Illinois	United States	60068
145	OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center	Pekin	Illinois	United States	61554
146	Pekin Hospital	Pekin	Illinois	United States	61554
147	Proctor Hospital	Peoria	Illinois	United States	61614
148	Illinois CancerCare-Peoria	Peoria	Illinois	United States	61615
149	Methodist Medical Center of Illinois	Peoria	Illinois	United States	61636
150	OSF Saint Francis Medical Center	Peoria	Illinois	United States	61637
151	Illinois Valley Hospital	Peru	Illinois	United States	61354
152	Valley Radiation Oncology	Peru	Illinois	United States	61354
153	Perry Memorial Hospital	Princeton	Illinois	United States	61356
154	Swedish American Hospital	Rockford	Illinois	United States	61104
155	OSF Saint Anthony Medical Center	Rockford	Illinois	United States	61108
156	Sarah Culbertson Memorial Hospital	Rushville	Illinois	United States	62681
157	Saint Margaret's Hospital	Spring Valley	Illinois	United States	61362
158	Memorial Medical Center	Springfield	Illinois	United States	62781
159	Carle Cancer Center	Urbana	Illinois	United States	61801
160	Franciscan Saint Francis Health-Beech Grove	Beech Grove	Indiana	United States	46107
161	Elkhart General Hospital	Elkhart	Indiana	United States	46515
162	Fort Wayne Medical Oncology and Hematology Inc-Parkview	Fort Wayne	Indiana	United States	46845
163	Indiana University/Melvin and Bren Simon Cancer Center	Indianapolis	Indiana	United States	46202
164	Saint Vincent Hospital and Health Care Center	Indianapolis	Indiana	United States	46260
165	Community Howard Regional Health	Kokomo	Indiana	United States	46904
166	IU Health La Porte Hospital	La Porte	Indiana	United States	46350
167	Franciscan Saint Anthony Health-Michigan City	Michigan City	Indiana	United States	46360
168	Saint Joseph Regional Medical Center-Mishawaka	Mishawaka	Indiana	United States	46545
169	Reid Health	Richmond	Indiana	United States	47374
170	Memorial Hospital of South Bend	South Bend	Indiana	United States	46601
171	Michiana Hematology Oncology PC-South Bend	South Bend	Indiana	United States	46601
172	South Bend Clinic	South Bend	Indiana	United States	46617
173	Northern Indiana Cancer Research Consortium	South Bend	Indiana	United States	46628
174	McFarland Clinic PC - Ames	Ames	Iowa	United States	50010
175	University of Iowa Healthcare Cancer Services Quad Cities	Bettendorf	Iowa	United States	52722
176	Saint Luke's Hospital	Cedar Rapids	Iowa	United States	52402
177	Mercy Hospital	Cedar Rapids	Iowa	United States	52403
178	Oncology Associates at Mercy Medical Center	Cedar Rapids	Iowa	United States	52403
179	Medical Oncology and Hematology Associates-West Des Moines	Clive	Iowa	United States	50325
180	Genesis Medical Center - East Campus	Davenport	Iowa	United States	52803
181	Genesis Cancer Care Institute	Davenport	Iowa	United States	52804
182	Mercy Capitol	Des Moines	Iowa	United States	50307
183	Iowa Methodist Medical Center	Des Moines	Iowa	United States	50309
184	Iowa-Wide Oncology Research Coalition NCORP	Des Moines	Iowa	United States	50309
185	Medical Oncology and Hematology Associates-Des Moines	Des Moines	Iowa	United States	50309
186	Medical Oncology and Hematology Associates-Laurel	Des Moines	Iowa	United States	50314
187	Mercy Medical Center - Des Moines	Des Moines	Iowa	United States	50314
188	Iowa Lutheran Hospital	Des Moines	Iowa	United States	50316
189	University of Iowa/Holden Comprehensive Cancer Center	Iowa City	Iowa	United States	52242
190	Mercy Medical Center - North Iowa	Mason City	Iowa	United States	50401
191	Siouxland Regional Cancer Center	Sioux City	Iowa	United States	51101
192	Mercy Medical Center-Sioux City	Sioux City	Iowa	United States	51102
193	Saint Luke's Regional Medical Center	Sioux City	Iowa	United States	51104
194	Cancer Center of Kansas - Chanute	Chanute	Kansas	United States	66720
195	Cancer Center of Kansas - Dodge City	Dodge City	Kansas	United States	67801
196	Cancer Center of Kansas - El Dorado	El Dorado	Kansas	United States	67042
197	Cancer Center of Kansas-Independence	Independence	Kansas	United States	67301
198	Providence Medical Center	Kansas City	Kansas	United States	66112
199	University of Kansas Cancer Center	Kansas City	Kansas	United States	66160
200	Cancer Center of Kansas-Kingman	Kingman	Kansas	United States	67068
201	Lawrence Memorial Hospital	Lawrence	Kansas	United States	66044
202	Southwest Medical Center	Liberal	Kansas	United States	67901
203	Cancer Center of Kansas - Newton	Newton	Kansas	United States	67114
204	Menorah Medical Center	Overland Park	Kansas	United States	66209
205	Radiation Oncology Practice Corporation Southwest	Overland Park	Kansas	United States	66210
206	Cancer Center of Kansas - Parsons	Parsons	Kansas	United States	67357
207	Ascension Via Christi - Pittsburg	Pittsburg	Kansas	United States	66762
208	Cancer Center of Kansas - Pratt	Pratt	Kansas	United States	67124
209	Cancer Center of Kansas - Salina	Salina	Kansas	United States	67401
210	Advent Health - Shawnee Mission Medical Center	Shawnee Mission	Kansas	United States	66204
211	Cotton O'Neil Cancer Center / Stormont Vail Health	Topeka	Kansas	United States	66606
212	University of Kansas Health System Saint Francis Campus	Topeka	Kansas	United States	66606
213	Cancer Center of Kansas - Wellington	Wellington	Kansas	United States	67152
214	Associates In Womens Health	Wichita	Kansas	United States	67208
215	Cancer Center of Kansas-Wichita Medical Arts Tower	Wichita	Kansas	United States	67208
216	Ascension Via Christi Hospitals Wichita	Wichita	Kansas	United States	67214
217	Cancer Center of Kansas - Wichita	Wichita	Kansas	United States	67214
218	Wichita NCI Community Oncology Research Program	Wichita	Kansas	United States	67214
219	Cancer Center of Kansas - Winfield	Winfield	Kansas	United States	67156
220	Saint Elizabeth Medical Center South	Edgewood	Kentucky	United States	41017
221	University of Kentucky/Markey Cancer Center	Lexington	Kentucky	United States	40536
222	Norton Hospital Pavilion and Medical Campus	Louisville	Kentucky	United States	40202
223	The James Graham Brown Cancer Center at University of Louisville	Louisville	Kentucky	United States	40202
224	Baton Rouge General Medical Center	Baton Rouge	Louisiana	United States	70806
225	Mary Bird Perkins Cancer Center	Baton Rouge	Louisiana	United States	70809
226	Woman's Hospital	Baton Rouge	Louisiana	United States	70817
227	Louisiana State University Health Science Center	New Orleans	Louisiana	United States	70112
228	Tulane University Health Sciences Center	New Orleans	Louisiana	United States	70112
229	University Medical Center New Orleans	New Orleans	Louisiana	United States	70112
230	Ochsner Medical Center Jefferson	New Orleans	Louisiana	United States	70121
231	Maine Medical Center-Bramhall Campus	Portland	Maine	United States	04102
232	University of Maryland/Greenebaum Cancer Center	Baltimore	Maryland	United States	21201
233	Greater Baltimore Medical Center	Baltimore	Maryland	United States	21204
234	MedStar Franklin Square Medical Center/Weinberg Cancer Institute	Baltimore	Maryland	United States	21237
235	Johns Hopkins University/Sidney Kimmel Cancer Center	Baltimore	Maryland	United States	21287
236	University of Maryland Shore Medical Center at Easton	Easton	Maryland	United States	21601
237	Christiana Care - Union Hospital	Elkton	Maryland	United States	21921
238	Kaiser Permanente - Largo Medical Center	Largo	Maryland	United States	20774
239	Kaiser Permanente - Towson Medical Center	Lutherville	Maryland	United States	21093
240	Kaiser Permanente - Shady Grove Medical Center	Rockville	Maryland	United States	20850
241	TidalHealth Peninsula Regional	Salisbury	Maryland	United States	21801
242	Tufts Medical Center	Boston	Massachusetts	United States	02111
243	Massachusetts General Hospital Cancer Center	Boston	Massachusetts	United States	02114
244	Brigham and Women's Hospital	Boston	Massachusetts	United States	02115
245	Dana-Farber Cancer Institute	Boston	Massachusetts	United States	02215
246	Dana Farber Community Cancer Care-Quincy	Quincy	Massachusetts	United States	02169
247	Baystate Medical Center	Springfield	Massachusetts	United States	01199
248	UMass Memorial Medical Center - University Campus	Worcester	Massachusetts	United States	01655
249	Bixby Medical Center	Adrian	Michigan	United States	49221
250	Hickman Cancer Center	Adrian	Michigan	United States	49221
251	Michigan Cancer Research Consortium NCORP	Ann Arbor	Michigan	United States	48106
252	Saint Joseph Mercy Hospital	Ann Arbor	Michigan	United States	48106
253	University of Michigan Comprehensive Cancer Center	Ann Arbor	Michigan	United States	48109
254	Bronson Battle Creek	Battle Creek	Michigan	United States	49017
255	Spectrum Health Big Rapids Hospital	Big Rapids	Michigan	United States	49307
256	Beaumont Hospital - Dearborn	Dearborn	Michigan	United States	48124
257	Wayne State University/Karmanos Cancer Institute	Detroit	Michigan	United States	48201
258	Henry Ford Hospital	Detroit	Michigan	United States	48202
259	Ascension Saint John Hospital	Detroit	Michigan	United States	48236
260	Green Bay Oncology - Escanaba	Escanaba	Michigan	United States	49829
261	Hurley Medical Center	Flint	Michigan	United States	48503
262	Genesys Regional Medical Center-West Flint Campus	Flint	Michigan	United States	48532
263	Cancer Research Consortium of West Michigan NCORP	Grand Rapids	Michigan	United States	49503
264	Mercy Health Saint Mary's	Grand Rapids	Michigan	United States	49503
265	Spectrum Health at Butterworth Campus	Grand Rapids	Michigan	United States	49503
266	Spectrum Health-Blodgett Campus	Grand Rapids	Michigan	United States	49506
267	Holland Community Hospital	Holland	Michigan	United States	49423
268	Green Bay Oncology - Iron Mountain	Iron Mountain	Michigan	United States	49801
269	Allegiance Health	Jackson	Michigan	United States	49201
270	Bronson Methodist Hospital	Kalamazoo	Michigan	United States	49007
271	West Michigan Cancer Center	Kalamazoo	Michigan	United States	49007
272	Kalamazoo Center for Medical Studies	Kalamazoo	Michigan	United States	49008
273	Borgess Medical Center	Kalamazoo	Michigan	United States	49048
274	Sparrow Hospital	Lansing	Michigan	United States	48912
275	Saint Mary Mercy Hospital	Livonia	Michigan	United States	48154
276	Mercy Memorial Hospital	Monroe	Michigan	United States	48162
277	Toledo Clinic Cancer Centers-Monroe	Monroe	Michigan	United States	48162
278	Mercy Health Partners-Hackley Campus	Muskegon	Michigan	United States	49442
279	Mercy Health Mercy Campus	Muskegon	Michigan	United States	49444
280	McLaren Cancer Institute-Northern Michigan	Petoskey	Michigan	United States	49770
281	Saint Joseph Mercy Oakland	Pontiac	Michigan	United States	48341
282	Lake Huron Medical Center	Port Huron	Michigan	United States	48060
283	William Beaumont Hospital-Royal Oak	Royal Oak	Michigan	United States	48073
284	Ascension Saint Mary's Hospital	Saginaw	Michigan	United States	48601
285	Lakeland Medical Center Saint Joseph	Saint Joseph	Michigan	United States	49085
286	Ascension Providence Hospitals - Southfield	Southfield	Michigan	United States	48075
287	Munson Medical Center	Traverse City	Michigan	United States	49684
288	Saint John Macomb-Oakland Hospital	Warren	Michigan	United States	48093
289	Metro Health Hospital	Wyoming	Michigan	United States	49519
290	Sanford Joe Lueken Cancer Center	Bemidji	Minnesota	United States	56601
291	Fairview Ridges Hospital	Burnsville	Minnesota	United States	55337
292	Mercy Hospital	Coon Rapids	Minnesota	United States	55433
293	Essentia Health Cancer Center	Duluth	Minnesota	United States	55805
294	Essentia Health Saint Mary's Medical Center	Duluth	Minnesota	United States	55805
295	Miller-Dwan Hospital	Duluth	Minnesota	United States	55805
296	Fairview Southdale Hospital	Edina	Minnesota	United States	55435
297	Unity Hospital	Fridley	Minnesota	United States	55432
298	Minnesota Oncology Hematology PA-Maplewood	Maplewood	Minnesota	United States	55109
299	Abbott-Northwestern Hospital	Minneapolis	Minnesota	United States	55407
300	University of Minnesota/Masonic Cancer Center	Minneapolis	Minnesota	United States	55455
301	North Memorial Medical Health Center	Robbinsdale	Minnesota	United States	55422
302	Mayo Clinic in Rochester	Rochester	Minnesota	United States	55905
303	Metro Minnesota Community Oncology Research Consortium	Saint Louis Park	Minnesota	United States	55416
304	Park Nicollet Clinic - Saint Louis Park	Saint Louis Park	Minnesota	United States	55416
305	United Hospital	Saint Paul	Minnesota	United States	55102
306	Saint Francis Regional Medical Center	Shakopee	Minnesota	United States	55379
307	Ridgeview Medical Center	Waconia	Minnesota	United States	55387
308	Minnesota Oncology Hematology PA-Woodbury	Woodbury	Minnesota	United States	55125
309	Saint Dominic-Jackson Memorial Hospital	Jackson	Mississippi	United States	39216
310	University of Mississippi Medical Center	Jackson	Mississippi	United States	39216
311	Keesler Medical Center	Keesler Air Force Base	Mississippi	United States	39534
312	Singing River Hospital	Pascagoula	Mississippi	United States	39581
313	Southeast Missouri Hospital	Cape Girardeau	Missouri	United States	63701
314	Saint Francis Medical Center	Cape Girardeau	Missouri	United States	63703
315	University of Missouri - Ellis Fischel	Columbia	Missouri	United States	65212
316	Centerpoint Medical Center LLC	Independence	Missouri	United States	64057
317	Freeman Health System	Joplin	Missouri	United States	64804
318	Truman Medical Centers	Kansas City	Missouri	United States	64108
319	Saint Luke's Hospital of Kansas City	Kansas City	Missouri	United States	64111
320	Radiation Oncology Practice Corporation South	Kansas City	Missouri	United States	64114
321	Saint Joseph Health Center	Kansas City	Missouri	United States	64114
322	North Kansas City Hospital	Kansas City	Missouri	United States	64116
323	Research Medical Center	Kansas City	Missouri	United States	64132
324	Radiation Oncology Practice Corporation - North	Kansas City	Missouri	United States	64154
325	Liberty Radiation Oncology Center	Liberty	Missouri	United States	64068
326	Heartland Regional Medical Center	Saint Joseph	Missouri	United States	64506
327	SSM Health Saint Louis University Hospital	Saint Louis	Missouri	United States	63104
328	Saint Louis Cancer and Breast Institute-South City	Saint Louis	Missouri	United States	63109
329	Washington University School of Medicine	Saint Louis	Missouri	United States	63110
330	Saint Mary's Hospital	Saint Louis	Missouri	United States	63117
331	Missouri Baptist Medical Center	Saint Louis	Missouri	United States	63131
332	Center for Cancer Care and Research	Saint Louis	Missouri	United States	63141
333	Mercy Hospital Saint Louis	Saint Louis	Missouri	United States	63141
334	Saint Louis-Cape Girardeau CCOP	Saint Louis	Missouri	United States	63141
335	Cancer Research for the Ozarks NCORP	Springfield	Missouri	United States	65804
336	Mercy Hospital Springfield	Springfield	Missouri	United States	65804
337	CoxHealth South Hospital	Springfield	Missouri	United States	65807
338	Billings Clinic Cancer Center	Billings	Montana	United States	59101
339	Northern Rockies Radiation Oncology Center	Billings	Montana	United States	59101
340	Saint Vincent Healthcare	Billings	Montana	United States	59101
341	Montana Cancer Consortium NCORP	Billings	Montana	United States	59102
342	Saint Vincent Frontier Cancer Center	Billings	Montana	United States	59102
343	Deaconess Medical Center	Billings	Montana	United States	59107
344	Bozeman Deaconess Hospital	Bozeman	Montana	United States	59715
345	Internal Medicine of Bozeman	Bozeman	Montana	United States	59715
346	Saint James Community Hospital and Cancer Treatment Center	Butte	Montana	United States	59701
347	Benefis Healthcare- Sletten Cancer Institute	Great Falls	Montana	United States	59405
348	Berdeaux, Donald MD (UIA Investigator)	Great Falls	Montana	United States	59405
349	Great Falls Clinic	Great Falls	Montana	United States	59405
350	Northern Montana Hospital	Havre	Montana	United States	59501
351	Saint Peter's Community Hospital	Helena	Montana	United States	59601
352	Glacier Oncology PLLC	Kalispell	Montana	United States	59901
353	Kalispell Medical Oncology	Kalispell	Montana	United States	59901
354	Kalispell Regional Medical Center	Kalispell	Montana	United States	59901
355	Eastern Montana Cancer Center	Miles City	Montana	United States	59301
356	Montana Cancer Specialists	Missoula	Montana	United States	59802
357	Saint Patrick Hospital - Community Hospital	Missoula	Montana	United States	59802
358	Community Medical Hospital	Missoula	Montana	United States	59804
359	Guardian Oncology and Center for Wellness	Missoula	Montana	United States	59804
360	CHI Health Good Samaritan	Kearney	Nebraska	United States	68847
361	Bryan LGH Medical Center West	Lincoln	Nebraska	United States	68502
362	Bryan LGH Medical Center East	Lincoln	Nebraska	United States	68506
363	Nebraska Cancer Research Center	Lincoln	Nebraska	United States	68510
364	Saint Elizabeth Regional Medical Center	Lincoln	Nebraska	United States	68510
365	Nebraska Methodist Hospital	Omaha	Nebraska	United States	68114
366	Alegent Health Immanuel Medical Center	Omaha	Nebraska	United States	68122
367	Alegent Health Bergan Mercy Medical Center	Omaha	Nebraska	United States	68124
368	Creighton University Medical Center	Omaha	Nebraska	United States	68131
369	University of Nebraska Medical Center	Omaha	Nebraska	United States	68198
370	University Medical Center of Southern Nevada	Las Vegas	Nevada	United States	89102
371	Nevada Cancer Research Foundation NCORP	Las Vegas	Nevada	United States	89169
372	Center of Hope at Renown Medical Center	Reno	Nevada	United States	89502
373	Renown Regional Medical Center	Reno	Nevada	United States	89502
374	Women's Cancer Center at Washoe	Reno	Nevada	United States	89502
375	Saint Mary's Regional Medical Center	Reno	Nevada	United States	89503
376	Dartmouth Hitchcock Medical Center	Lebanon	New Hampshire	United States	03756
377	Cooper Hospital University Medical Center	Camden	New Jersey	United States	08103
378	Hunterdon Medical Center	Flemington	New Jersey	United States	08822
379	Saint Barnabas Medical Center	Livingston	New Jersey	United States	07039
380	Mountainside Hospital	Montclair	New Jersey	United States	07042
381	Morristown Medical Center	Morristown	New Jersey	United States	07960
382	Virtua Memorial	Mount Holly	New Jersey	United States	08060
383	Inspira Medical Center Mullica Hill	Mullica Hill	New Jersey	United States	08062
384	Jersey Shore Medical Center	Neptune	New Jersey	United States	07753
385	Rutgers Cancer Institute of New Jersey	New Brunswick	New Jersey	United States	08903
386	Rutgers New Jersey Medical School	Newark	New Jersey	United States	07101
387	AtlantiCare Regional Medical Center -Main Campus	Pomona	New Jersey	United States	08240
388	Riverview Medical Center/Booker Cancer Center	Red Bank	New Jersey	United States	07701
389	Sparta Cancer Treatment Center	Sparta	New Jersey	United States	07871
390	Overlook Hospital	Summit	New Jersey	United States	07902
391	Inspira Medical Center Vineland	Vineland	New Jersey	United States	08360
392	Virtua Voorhees	Voorhees	New Jersey	United States	08043
393	University of New Mexico Cancer Center	Albuquerque	New Mexico	United States	87102
394	Southwest Gynecologic Oncology Associates Inc	Albuquerque	New Mexico	United States	87106
395	New York Oncology Hematology PC - Albany Medical Center	Albany	New York	United States	12208
396	Women's Cancer Care Associates LLC	Albany	New York	United States	12208
397	New York Oncology Hematology PC - Amsterdam	Amsterdam	New York	United States	12010
398	Island Gynecologic Oncology	Brightwaters	New York	United States	11718
399	Montefiore Medical Center-Einstein Campus	Bronx	New York	United States	10461
400	Montefiore Medical Center-Wakefield Campus	Bronx	New York	United States	10466
401	Montefiore Medical Center - Moses Campus	Bronx	New York	United States	10467
402	State University of New York Downstate Medical Center	Brooklyn	New York	United States	11203
403	Roswell Park Cancer Institute	Buffalo	New York	United States	14263
404	New York Oncology Hematology PC - Clifton Park	Clifton Park	New York	United States	12065
405	New York Oncology Hematology PC-Hudson	Hudson	New York	United States	12534
406	Northwell Health NCORP	Lake Success	New York	United States	11042
407	North Shore University Hospital	Manhasset	New York	United States	11030
408	Long Island Jewish Medical Center	New Hyde Park	New York	United States	11040
409	Laura and Isaac Perlmutter Cancer Center at NYU Langone	New York	New York	United States	10016
410	Mount Sinai Hospital	New York	New York	United States	10029
411	NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center	New York	New York	United States	10032
412	Memorial Sloan Kettering Cancer Center	New York	New York	United States	10065
413	South Nassau Communities	Oceanside	New York	United States	11572
414	Stony Brook University Medical Center	Stony Brook	New York	United States	11794
415	Good Samaritan Hospital Medical Center	West Islip	New York	United States	11795
416	Randolph Hospital	Asheboro	North Carolina	United States	27203
417	Hope Women's Cancer Centers-Asheville	Asheville	North Carolina	United States	28816
418	Cone Health Cancer Center at Alamance Regional	Burlington	North Carolina	United States	27215
419	UNC Lineberger Comprehensive Cancer Center	Chapel Hill	North Carolina	United States	27599
420	Carolinas Medical Center/Levine Cancer Institute	Charlotte	North Carolina	United States	28203
421	Novant Health Presbyterian Medical Center	Charlotte	North Carolina	United States	28204
422	Duke University Medical Center	Durham	North Carolina	United States	27710
423	Moorehead Memorial Hospital	Eden	North Carolina	United States	27288
424	Wayne Memorial Hospital	Goldsboro	North Carolina	United States	27534
425	Wayne Radiation Oncology	Goldsboro	North Carolina	United States	27534
426	Cone Health Cancer Center	Greensboro	North Carolina	United States	27403
427	Gynecologic Oncology Network	Greenville	North Carolina	United States	27834
428	Vidant Medical Center	Greenville	North Carolina	United States	27834
429	Vidant Oncology-Kinston	Kinston	North Carolina	United States	28501
430	FirstHealth of the Carolinas-Moore Regional Hospital	Pinehurst	North Carolina	United States	28374
431	Annie Penn Memorial Hospital	Reidsville	North Carolina	United States	27320
432	Wilson Medical Center	Wilson	North Carolina	United States	27893
433	Novant Health Oncology Specialists	Winston-Salem	North Carolina	United States	27103
434	Wake Forest University Health Sciences	Winston-Salem	North Carolina	United States	27157
435	Mid Dakota Clinic	Bismarck	North Dakota	United States	58501
436	Saint Alexius Medical Center	Bismarck	North Dakota	United States	58501
437	Sanford Bismarck Medical Center	Bismarck	North Dakota	United States	58501
438	Sanford Broadway Medical Center	Fargo	North Dakota	United States	58122
439	Summa Health System - Akron Campus	Akron	Ohio	United States	44304
440	Cleveland Clinic Akron General	Akron	Ohio	United States	44307
441	Saint Elizabeth Boardman Hospital	Boardman	Ohio	United States	44512
442	Toledo Clinic Cancer Centers-Bowling Green	Bowling Green	Ohio	United States	43402
443	Cleveland Clinic Mercy Hospital	Canton	Ohio	United States	44708
444	Aultman Health Foundation	Canton	Ohio	United States	44710
445	University of Cincinnati Cancer Center-UC Medical Center	Cincinnati	Ohio	United States	45219
446	Good Samaritan Hospital - Cincinnati	Cincinnati	Ohio	United States	45220
447	Case Western Reserve University	Cleveland	Ohio	United States	44106
448	MetroHealth Medical Center	Cleveland	Ohio	United States	44109
449	Cleveland Clinic Cancer Center/Fairview Hospital	Cleveland	Ohio	United States	44111
450	Cleveland Clinic Foundation	Cleveland	Ohio	United States	44195
451	North Coast Cancer Care-Clyde	Clyde	Ohio	United States	43410
452	Ohio State University Comprehensive Cancer Center	Columbus	Ohio	United States	43210
453	Riverside Methodist Hospital	Columbus	Ohio	United States	43214
454	Mount Carmel Health Center West	Columbus	Ohio	United States	43222
455	Grandview Hospital	Dayton	Ohio	United States	45405
456	Good Samaritan Hospital - Dayton	Dayton	Ohio	United States	45406
457	Miami Valley Hospital	Dayton	Ohio	United States	45409
458	Miami Valley Hospital North	Dayton	Ohio	United States	45415
459	Dayton Veterans Affairs Medical Center	Dayton	Ohio	United States	45428
460	Dayton NCI Community Oncology Research Program	Dayton	Ohio	United States	45459
461	Hematology Oncology Center Incorporated	Elyria	Ohio	United States	44035
462	Blanchard Valley Hospital	Findlay	Ohio	United States	45840
463	Atrium Medical Center-Middletown Regional Hospital	Franklin	Ohio	United States	45005-1066
464	Fremont Memorial Hospital	Fremont	Ohio	United States	43420
465	Kettering Medical Center	Kettering	Ohio	United States	45429
466	Saint Rita's Medical Center	Lima	Ohio	United States	45801
467	Lima Memorial Hospital	Lima	Ohio	United States	45804
468	Saint Luke's Hospital	Maumee	Ohio	United States	43537
469	Toledo Clinic Cancer Centers-Maumee	Maumee	Ohio	United States	43537
470	Toledo Radiation Oncology at Northwest Ohio Onocolgy Center	Maumee	Ohio	United States	43537
471	Hillcrest Hospital Cancer Center	Mayfield Heights	Ohio	United States	44124
472	UH Seidman Cancer Center at Lake Health Mentor Campus	Mentor	Ohio	United States	44060
473	Saint Charles Hospital	Oregon	Ohio	United States	43616
474	Toledo Clinic Cancer Centers-Oregon	Oregon	Ohio	United States	43616
475	UH Seidman Cancer Center at Salem Regional Medical Center	Salem	Ohio	United States	44460
476	Firelands Regional Medical Center	Sandusky	Ohio	United States	44870
477	North Coast Cancer Care	Sandusky	Ohio	United States	44870
478	ProMedica Flower Hospital	Sylvania	Ohio	United States	43560
479	Mercy Hospital of Tiffin	Tiffin	Ohio	United States	44883
480	ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital	Toledo	Ohio	United States	43606
481	Saint Vincent Mercy Medical Center	Toledo	Ohio	United States	43608
482	University of Toledo	Toledo	Ohio	United States	43614
483	Toledo Community Hospital Oncology Program CCOP	Toledo	Ohio	United States	43617
484	Mercy Health - Saint Anne Hospital	Toledo	Ohio	United States	43623
485	Toledo Clinic Cancer Centers-Toledo	Toledo	Ohio	United States	43623
486	Upper Valley Medical Center	Troy	Ohio	United States	45373
487	Saint Joseph Warren Hospital	Warren	Ohio	United States	44484
488	Fulton County Health Center	Wauseon	Ohio	United States	43567
489	Clinton Memorial Hospital	Wilmington	Ohio	United States	45177
490	Cancer Treatment Center	Wooster	Ohio	United States	44691
491	Wright-Patterson Medical Center	Wright-Patterson Air Force Base	Ohio	United States	45433
492	Greene Memorial Hospital	Xenia	Ohio	United States	45385
493	Saint Elizabeth Youngstown Hospital	Youngstown	Ohio	United States	44501
494	University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma	United States	73104
495	Oklahoma Cancer Specialists and Research Institute-Tulsa	Tulsa	Oklahoma	United States	74146
496	Three Rivers Community Hospital	Grants Pass	Oregon	United States	97527
497	Asante Health System	Medford	Oregon	United States	97504
498	Providence Medford Medical Center	Medford	Oregon	United States	97504
499	Rogue Valley Medical Center	Medford	Oregon	United States	97504
500	Legacy Good Samaritan Hospital and Medical Center	Portland	Oregon	United States	97210
501	Compass Oncology Rose Quarter	Portland	Oregon	United States	97227
502	Kaiser Permanente Northwest	Portland	Oregon	United States	97227
503	Oregon Health and Science University	Portland	Oregon	United States	97239
504	Jefferson Abington Hospital	Abington	Pennsylvania	United States	19001
505	Lehigh Valley Hospital-Cedar Crest	Allentown	Pennsylvania	United States	18103
506	Saint Luke's University Hospital-Bethlehem Campus	Bethlehem	Pennsylvania	United States	18015
507	Bryn Mawr Hospital	Bryn Mawr	Pennsylvania	United States	19010
508	Marion Community Hospital	Carbondale	Pennsylvania	United States	18407
509	Mercy Fitzgerald Hospital	Darby	Pennsylvania	United States	19023-1291
510	Oncology Hematology Associates of Northern Pennsylvania	DuBois	Pennsylvania	United States	15801
511	Pocono Medical Center	East Stroudsburg	Pennsylvania	United States	18301
512	Ephrata Cancer Center	Ephrata	Pennsylvania	United States	17522
513	Penn State Milton S Hershey Medical Center	Hershey	Pennsylvania	United States	17033-0850
514	Riddle Memorial Hospital	Media	Pennsylvania	United States	19063
515	Paoli Memorial Hospital	Paoli	Pennsylvania	United States	19301
516	Drexel University School of Medicine	Philadelphia	Pennsylvania	United States	19102
517	University of Pennsylvania/Abramson Cancer Center	Philadelphia	Pennsylvania	United States	19104
518	Pennsylvania Hospital	Philadelphia	Pennsylvania	United States	19107
519	Thomas Jefferson University Hospital	Philadelphia	Pennsylvania	United States	19107
520	Fox Chase Cancer Center	Philadelphia	Pennsylvania	United States	19111
521	Jefferson Torresdale Hospital	Philadelphia	Pennsylvania	United States	19114
522	Temple University Hospital	Philadelphia	Pennsylvania	United States	19140
523	Einstein Medical Center Philadelphia	Philadelphia	Pennsylvania	United States	19141
524	UPMC-Magee Womens Hospital	Pittsburgh	Pennsylvania	United States	15213
525	West Penn Hospital	Pittsburgh	Pennsylvania	United States	15224
526	Guthrie Medical Group PC-Robert Packer Hospital	Sayre	Pennsylvania	United States	18840
527	Mercy Hospital	Scranton	Pennsylvania	United States	18501
528	Hematology and Oncology Associates of North East Pennsylvania	Scranton	Pennsylvania	United States	18508
529	Moses Taylor Hospital	Scranton	Pennsylvania	United States	18510
530	Scranton Hematology Oncology	Scranton	Pennsylvania	United States	18510
531	Associates In Hematology Oncology PC-Upland	Upland	Pennsylvania	United States	19013
532	Reading Hospital	West Reading	Pennsylvania	United States	19611
533	Lankenau Medical Center	Wynnewood	Pennsylvania	United States	19096
534	Main Line Health NCORP	Wynnewood	Pennsylvania	United States	19096
535	Women and Infants Hospital	Providence	Rhode Island	United States	02905
536	Medical University of South Carolina	Charleston	South Carolina	United States	29425
537	Prisma Health Richland Hospital	Columbia	South Carolina	United States	29203
538	University of South Carolina School of Medicine	Columbia	South Carolina	United States	29208
539	South Carolina Oncology Associates PA	Columbia	South Carolina	United States	29210
540	Black Hills Obstetrics and Gynecology	Rapid City	South Dakota	United States	57701
541	Sanford Cancer Center Oncology Clinic	Sioux Falls	South Dakota	United States	57104
542	Sanford USD Medical Center - Sioux Falls	Sioux Falls	South Dakota	United States	57117-5134
543	Chattanooga's Program in Women's Oncology	Chattanooga	Tennessee	United States	37403
544	East Tennessee State University	Johnson City	Tennessee	United States	37614-0054
545	Southeast Gynecologic Oncology Associates	Knoxville	Tennessee	United States	37917
546	East Tennessee Baptist Hospital-Mercy Health Partners	Knoxville	Tennessee	United States	37920
547	Knoxville Gynecologic Cancer Specialists PC	Knoxville	Tennessee	United States	37920
548	Baptist Memorial Hospital and Cancer Center-Memphis	Memphis	Tennessee	United States	38120
549	University of Tennessee Health Science Center	Memphis	Tennessee	United States	38163
550	Meharry Medical College	Nashville	Tennessee	United States	37208
551	Vanderbilt University/Ingram Cancer Center	Nashville	Tennessee	United States	37232
552	The Don and Sybil Harrington Cancer Center	Amarillo	Texas	United States	79106
553	Parkland Memorial Hospital	Dallas	Texas	United States	75235
554	Clements University Hospital	Dallas	Texas	United States	75390
555	UT Southwestern/Simmons Cancer Center-Dallas	Dallas	Texas	United States	75390
556	Brooke Army Medical Center	Fort Sam Houston	Texas	United States	78234
557	University of Texas Medical Branch	Galveston	Texas	United States	77555-0565
558	Houston Methodist Hospital	Houston	Texas	United States	77030
559	M D Anderson Cancer Center	Houston	Texas	United States	77030
560	Texas Tech University Health Sciences Center-Lubbock	Lubbock	Texas	United States	79430
561	Scott and White Memorial Hospital	Temple	Texas	United States	76508
562	American Fork Hospital / Huntsman Intermountain Cancer Center	American Fork	Utah	United States	84003
563	Sandra L Maxwell Cancer Center	Cedar City	Utah	United States	84720
564	Logan Regional Hospital	Logan	Utah	United States	84321
565	Cottonwood Hospital Medical Center	Murray	Utah	United States	84107
566	Intermountain Medical Center	Murray	Utah	United States	84107
567	McKay-Dee Hospital Center	Ogden	Utah	United States	84403
568	Utah Valley Regional Medical Center	Provo	Utah	United States	84604
569	Dixie Medical Center Regional Cancer Center	Saint George	Utah	United States	84770
570	Intermountain Health Care	Salt Lake City	Utah	United States	84103
571	Utah Cancer Specialists-Salt Lake City	Salt Lake City	Utah	United States	84106
572	Huntsman Cancer Institute/University of Utah	Salt Lake City	Utah	United States	84112
573	LDS Hospital	Salt Lake City	Utah	United States	84143
574	University of Vermont Medical Center	Burlington	Vermont	United States	05401
575	Northern Virginia Pelvic Surgery Associates	Annandale	Virginia	United States	22003
576	University of Virginia Cancer Center	Charlottesville	Virginia	United States	22908
577	Danville Regional Medical Center	Danville	Virginia	United States	24541
578	Kaiser Permanente - Fair Oaks Medical Center	Fairfax	Virginia	United States	22033
579	Southside Community Hospital	Farmville	Virginia	United States	23901
580	Fredericksburg Oncology Inc	Fredericksburg	Virginia	United States	22401
581	Peninsula Cancer Institute-Gloucester	Gloucester	Virginia	United States	23061
582	Virginia Oncology Associates-Hampton	Hampton	Virginia	United States	23666
583	Rappahannock General Hospital	Kilmarnock	Virginia	United States	22482
584	Peninsula Cancer Institute-Newport News	Newport News	Virginia	United States	23601
585	Bon Secours Mary Immaculate Hospital	Newport News	Virginia	United States	23602
586	Virginia Oncology Associates - Lake Wright	Norfolk	Virginia	United States	23502
587	Bon Secours Saint Mary's Hospital	Richmond	Virginia	United States	23226
588	Richmond Radiation Oncology Center	Richmond	Virginia	United States	23228
589	Virginia Commonwealth University/Massey Cancer Center	Richmond	Virginia	United States	23298
590	Oncology and Hematology Associates of Southwest Virginia	Roanoke	Virginia	United States	24014
591	Carilion Clinic Gynecological Oncology	Roanoke	Virginia	United States	24016
592	VCU Community Memorial Health Center	South Hill	Virginia	United States	23970
593	Peninsula Cancer Institute-Williamsburg	Williamsburg	Virginia	United States	23185
594	Fred Hutchinson Cancer Research Center	Seattle	Washington	United States	98109
595	University of Washington Medical Center - Montlake	Seattle	Washington	United States	98195
596	MultiCare Tacoma General Hospital	Tacoma	Washington	United States	98405
597	Northwest Medical Specialties PLLC	Tacoma	Washington	United States	98405
598	PeaceHealth Southwest Medical Center	Vancouver	Washington	United States	98664
599	HSHS Sacred Heart Hospital	Eau Claire	Wisconsin	United States	54701
600	Marshfield Clinic Cancer Center at Sacred Heart	Eau Claire	Wisconsin	United States	54701
601	Saint Agnes Hospital/Agnesian Cancer Center	Fond Du Lac	Wisconsin	United States	54935
602	Green Bay Oncology at Saint Vincent Hospital	Green Bay	Wisconsin	United States	54301-3526
603	Saint Vincent Hospital Cancer Center Green Bay	Green Bay	Wisconsin	United States	54301
604	Green Bay Oncology Limited at Saint Mary's Hospital	Green Bay	Wisconsin	United States	54303
605	Saint Vincent Hospital Cancer Center at Saint Mary's	Green Bay	Wisconsin	United States	54303
606	Gundersen Lutheran Medical Center	La Crosse	Wisconsin	United States	54601
607	University of Wisconsin Hospital and Clinics	Madison	Wisconsin	United States	53792
608	Holy Family Memorial Hospital	Manitowoc	Wisconsin	United States	54221
609	Bay Area Medical Center	Marinette	Wisconsin	United States	54143
610	Marshfield Medical Center-Marshfield	Marshfield	Wisconsin	United States	54449
611	Marshfield Medical Center	Marshfield	Wisconsin	United States	54449
612	Ascension Columbia Saint Mary's Hospital Ozaukee	Mequon	Wisconsin	United States	53097
613	Ascension Columbia Saint Mary's Hospital - Milwaukee	Milwaukee	Wisconsin	United States	53211
614	Aurora Saint Luke's Medical Center	Milwaukee	Wisconsin	United States	53215
615	Medical College of Wisconsin	Milwaukee	Wisconsin	United States	53226
616	Marshfield Clinic-Minocqua Center	Minocqua	Wisconsin	United States	54548
617	ProHealth Oconomowoc Memorial Hospital	Oconomowoc	Wisconsin	United States	53066
618	Saint Vincent Hospital Cancer Center at Oconto Falls	Oconto Falls	Wisconsin	United States	54154
619	Ascension All Saints Hospital	Racine	Wisconsin	United States	53405
620	Ascension Saint Mary's Hospital	Rhinelander	Wisconsin	United States	54501
621	Marshfield Medical Center-Rice Lake	Rice Lake	Wisconsin	United States	54868
622	Vince Lombardi Cancer Clinic-Sheboygan	Sheboygan	Wisconsin	United States	53081
623	Vince Lombardi Cancer Clinic - Slinger	Slinger	Wisconsin	United States	53086
624	Ascension Saint Michael's Hospital	Stevens Point	Wisconsin	United States	54481
625	Green Bay Oncology - Sturgeon Bay	Sturgeon Bay	Wisconsin	United States	54235
626	ProHealth Waukesha Memorial Hospital	Waukesha	Wisconsin	United States	53188
627	Marshfield Clinic-Wausau Center	Wausau	Wisconsin	United States	54401
628	Aurora West Allis Medical Center	West Allis	Wisconsin	United States	53227
629	Marshfield Medical Center - Weston	Weston	Wisconsin	United States	54476
630	Marshfield Clinic - Wisconsin Rapids Center	Wisconsin Rapids	Wisconsin	United States	54494
631	Welch Cancer Center	Sheridan	Wyoming	United States	82801
632	McGill University Health Centre at Royal Victoria Hospital	Montreal	Quebec	Canada	H3A 1A1
633	Montreal General Hospital	Montreal	Quebec	Canada	H3G 1A4
634	Saint Mary's Hospital	Montreal	Quebec	Canada	H3T 1M5
635	CHU de Quebec-L'Hotel-Dieu de Quebec (HDQ)	Quebec City	Quebec	Canada	G1R 2J6
636	Tohoku University School of Medicine	Sendai	Aoba-ku	Japan	980-8574
637	Kure National Hospital	Kure	Hiroshima	Japan	737
638	Hokkaido University Hospital	Sapporo	Hokkaido	Japan	060-8648
639	Iwate Medical University Hospital	Shiwa-gun	Iwate	Japan	028-3695
640	Kagoshima City Hospital	Kagoshima City	Kagoshima	Japan	890-8760
641	Jikei University Aoto Hospital	Katsushika-ku	Tokyo	Japan	125-8506
642	Keio University	Shinjuku-ku	Tokyo	Japan	160-8582
643	Hiroshima University Hospital	Hiroshima City		Japan	734-8551
644	National Hospital Organization-Kobe Medical Center	Kobe		Japan	654-0155
645	Shikoku Cancer Center	Matsuyama		Japan	791-0280
646	National Kyushu Cancer Center	Minami-ku		Japan	811 1395
647	Jikei University School of Medicine	Minato-ku, Tokyo		Japan	105-8461
648	Saitama Medical University International Medical Center	Saitama		Japan	350-1298
649	National Cancer Center Hospital	Tokyo		Japan	104 0045
650	Tottori University	Tottori		Japan	680-8550

Sponsors and Collaborators

• GOG Foundation
• National Cancer Institute (NCI)

Investigators

• Principal Investigator: David S Miller, NRG Oncology

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: GOG Foundation
• ClinicalTrials.gov Identifier: NCT00063999
• Other Study ID Numbers: GOG-0209; NCI-2009-00584; CDR0000305940; GOG-0209; GOG-0209; U10CA180868; U10CA027469
• First Posted: Jul 9, 2003
• Last Update Posted: Oct 19, 2021
• Last Verified: Sep 1, 2021

• Additional relevant MeSH terms: Endometrial Neoplasms; Recurrence; Paclitaxel; Cisplatin; Carboplatin; Doxorubicin; Liposomal doxorubicin; Albumin-Bound Paclitaxel; Lenograstim

Study Results

Participant Flow

Recruitment Details	GOG 0209 accrued 1381 patients from August 2003 to April 2009. 1312 of these patients were eligible.

Arm/Group Title	Doxorubicin, Cisplatin, Paclitaxel	Paclitaxel, Carboplatin
Arm/Group Description	Patients receive doxorubicin IV over approximately 15-30 minutes on day 1, cisplatin IV over 60-90 minutes on day 1, paclitaxel IV over 3 hours on day 2, and filgrastim SC on days 3-12 or pegfilgrastim SC on day 3. Treatment repeats every 21 days for 7 courses in the absence of disease progression or unacceptable toxicity.	Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for 7 courses in the absence of disease progression or unacceptable toxicity.
Period Title: Overall Study
STARTED	692	689
COMPLETED	647	665
NOT COMPLETED	45	24

Baseline Characteristics

Arm/Group Title	Arm I (Doxorubicin Hydrochloride, Cisplatin, Paclitaxel)	Arm II (Paclitaxel, Carboplatin)	Total
Arm/Group Description	Patients receive doxorubicin hydrochloride IV over approximately 15-30 minutes on day 1, cisplatin IV over 60-90 minutes on day 1, paclitaxel IV over 3 hours on day 2, and filgrastim SC on days 3-12 or pegfilgrastim SC on day 3. Treatment repeats every 21 days for 7 courses in the absence of disease progression or unacceptable toxicity.	Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for 7 courses in the absence of disease progression or unacceptable toxicity.	Total of all reporting groups
Overall Participants	647	665	1312
Age, Customized (Count of Participants)
<40 years	19 2.9%	18 2.7%	37 2.8%
40 -49 years	67 10.4%	70 10.5%	137 10.4%
50-59 years	192 29.7%	219 32.9%	411 31.3%
60-60 years	256 39.6%	244 36.7%	500 38.1%
>=70 years	113 17.5%	114 17.1%	227 17.3%
Sex: Female, Male (Count of Participants)
Female	647 100%	665 100%	1312 100%
Male	0 0%	0 0%	0 0%

Outcome Measures

1. Primary Outcome

Title	Number of Participants Alive at Time of Last Follow-up.
Description	The time alive in months from study entry to last contact or death.
Time Frame	Patients were assessed during treatment. Following completion of treatment, follow up was assessed every 3 months for 2 years, then every 6 months for 3 years and annually after for a maximum of 10 years.

Outcome Measure Data

Analysis Population Description

Eligible and treated patients. Data are reported from the second interim analysis.

Arm/Group Title	Arm I (Doxorubicin, Cisplatin, Paclitaxel)	Arm II (Paclitaxel, Carboplatin)
Arm/Group Description	Patients receive doxorubicin IV over approximately 15-30 minutes on day 1, cisplatin IV over 60-90 minutes on day 1, paclitaxel IV over 3 hours on day 2, and filgrastim SC on days 3-12 or pegfilgrastim SC on day 3. Treatment repeats every 21 days for 7 courses in the absence of disease progression or unacceptable toxicity.	Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for 7 courses in the absence of disease progression or unacceptable toxicity.
Measure Participants	647	665
Alive	376 58.1%	385 57.9%
Dead	271 41.9%	280 42.1%

2. Secondary Outcome

Title	Patient-reported Neurotoxicity (Ntx) as Measured by the FACT/GOG-Ntx Subscale (Short)
Description	The FACT/GOG-Ntx subscale (short version) contains 4 items measuring sensory neuropathy. Each item is scored using a 5-point Likert scale (0=not at all; 1= a little bit; 2=somewhat; 3=quite a bit; 4=very much). For east item, reversal was performed prior to score calculation so that a large score suggests less symptom. according to the FACIT measurement system, the subscale score was calculated as the summation of the individual item scores if more than 50% of subscale items were answered. When unanswered items existed, a subscale score was prorated by multiplying the mean of the answered item scores by the number of items in the subscale. The Ntx subscale score ranges 0-16 with a large subscale score suggests less symptom or better QOL (Quality of Life).
Time Frame	Baseline, 6 weeks post treatment start, 15 weeks post treatment start and 26 weeks post treatment start

Outcome Measure Data

Analysis Population Description

Eligible and evaluable and enrolled prior to 3/26/2006

Arm/Group Title	Doxorubicin, Cisplatin, Paclitaxel	Paclitaxel, Carboplatin
Arm/Group Description	Patients receive doxorubicin IV over approximately 15-30 minutes on day 1, cisplatin IV over 60-90 minutes on day 1, paclitaxel IV over 3 hours on day 2, and filgrastim SC on days 3-12 or pegfilgrastim SC on day 3. Treatment repeats every 21 days for 7 courses in the absence of disease progression or unacceptable toxicity.	Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for 7 courses in the absence of disease progression or unacceptable toxicity.
Measure Participants	228	246
Baseline	14.9 (0.15)	14.9 (0.14)
6 Weeks	13.5 (0.28)	11.3 (0.27)
15 Weeks	11.1 (0.37)	11.2 (0.34)
26 Weeks	9.5 (0.41)	10.9 (0.36)

3. Secondary Outcome

Title	Patient Reported Quality of Life as Measured With the Combination of Physical Well-being (PWB) Subscale and Functional Well-being (FWB) Subscale From the FACT-G
Description	The FACT-G contains 4 subscales: Physical Well Being (7 items), Social Well Being (7 items), Emotional Well Being (6 items), Functional Well Being (7 items). The combination (14 items) of the physical well-being (PWB) and functional well-being (FWB) subscales was used to measure the HRQOL (Health Related Quality of Life). Each item is scored using a 5-point Likert scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). for each negative item, reversal was performed prior to score calculation so that a large score suggests better QOL. A subscale score was calculated as the summation of the individual item scores if more than 50% of subscale items were answered. When unanswered items existed, a subscale score was prorated by multiplying the mean of the answred item scores by the number of items in the subscale. The QOL was measured with the summation of the PWB and FWBsubscale score and ranges 0-56 with a large score suggests better QOL.
Time Frame	Pre-treatment, 6 weeks post starting treatment (prior to cycle 3), 15 weeks post starting treatment (prior to cycle 6), 26 weeks post starting treatment

Outcome Measure Data

Analysis Population Description

Eligible and evaluable and enrolled prior to 3/26/2006

Arm/Group Title	Arm I (Doxorubicin, Cisplatin, Paclitaxel)	Arm II (Paclitaxel, Carboplatin)
Arm/Group Description	Patients receive doxorubicin IV over approximately 15-30 minutes on day 1, cisplatin IV over 60-90 minutes on day 1, paclitaxel IV over 3 hours on day 2, and filgrastim SC on days 3-12 or pegfilgrastim SC on day 3. Treatment repeats every 21 days for 7 courses in the absence of disease progression or unacceptable toxicity.	Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for 7 courses in the absence of disease progression or unacceptable toxicity.
Measure Participants	228	246
Baseline	39.4 (0.72)	37.9 (0.7)
6 weeks	35.5 (0.73)	37.5 (0.68)
15 weeks	35.3 (0.74)	36.5 (0.7)
26 weeks	39.8 (0.8)	38.5 (0.81)

4. Secondary Outcome

Title	Number of Participants Alive at Time of Last Follow-up by Estrogen or Progesterone Receptor Status (Positive or Negative)
Description	The time alive in months from study entry to last contact or death.
Time Frame	Patients were assessed during treatment. Following completion of treatment, follow up was assessed every 3 months for 2 years, then every 6 months for 3 years and annually thereafter, for a maximum of 10 years.

Outcome Measure Data

Analysis Population Description

Eligible patients with estrogen and progesterone receptor data.

Arm/Group Title	Estrogen Receptor Positive	Estrogen Receptor Negative	Progesterone Receptor Positive	Progesterone Receptor Negative
Arm/Group Description	Patients with estrogen receptor positive tumors	Patients with estrogen receptor negative tumors	Patients with progesterone receptor positive tumors	Patients with progesterone receptor negative tumors
Measure Participants	919	355	832	440
Alive	408 63.1%	90 13.5%	380 29%	117 NaN
Dead	511 79%	265 39.8%	452 34.5%	323 NaN

5. Secondary Outcome

Title	Number of Participants With Indicated Severity of CTCAE v2 Graded Neurotoxicity and Infection
Description	Maximum grade of physician assessed neurotoxicity and infection
Time Frame	Assessed throughout the treatment period and for 30 days after discontinuation of treatment.

Outcome Measure Data

Analysis Population Description

Eligible and treated patients

Arm/Group Title	Arm I (Doxorubicin Hydrochloride, Cisplatin, Paclitaxel)	Arm II (Paclitaxel, Carboplatin)
Arm/Group Description	Patients receive doxorubicin hydrochloride IV over approximately 15-30 minutes on day 1, cisplatin IV over 60-90 minutes on day 1, paclitaxel IV over 3 hours on day 2, and filgrastim SC on days 3-12 or pegfilgrastim SC on day 3. Treatment repeats every 21 days for 7 courses in the absence of disease progression or unacceptable toxicity.	Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for 7 courses in the absence of disease progression or unacceptable toxicity.
Measure Participants	640	664
Grade < 2 Sensory neuropathy	167 25.8%	130 19.5%
Grade 2 or Higher Sensory Neuropathy	473 73.1%	534 80.3%
Grade <3 infection with Neutrope	25 3.9%	29 4.4%
Grade 3 or Higher Infection with Neutropenia	615 95.1%	635 95.5%
Grade <3 infection without Neutropenia	22 3.4%	13 2%
Grade 3 or Higher Infection without Neutropenia	618 95.5%	651 97.9%

Adverse Events

Time Frame	Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years.
Adverse Event Reporting Description	CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.
Arm/Group Title	Arm I (Doxorubicin, Cisplatin, Paclitaxel)		Arm II (Paclitaxel, Carboplatin)
Arm/Group Description	Patients receive doxorubicin IV over approximately 15-30 minutes on day 1, cisplatin IV over 60-90 minutes on day 1, paclitaxel IV over 3 hours on day 2, and filgrastim SC on days 3-12 or pegfilgrastim SC on day 3. Treatment repeats every 21 days for 7 courses in the absence of disease progression or unacceptable toxicity.		Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for 7 courses in the absence of disease progression or unacceptable toxicity.
All Cause Mortality
	Arm I (Doxorubicin, Cisplatin, Paclitaxel)		Arm II (Paclitaxel, Carboplatin)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	271/647 (41.9%)		280/665 (42.1%)
Serious Adverse Events
	Arm I (Doxorubicin, Cisplatin, Paclitaxel)		Arm II (Paclitaxel, Carboplatin)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	217/647 (33.5%)		156/665 (23.5%)
Blood and lymphatic system disorders
Hemoglobin	5/647 (0.8%)		10/665 (1.5%)
Hematologic-Other	0/647 (0%)		1/665 (0.2%)
Transfusion: Platelets	1/647 (0.2%)		0/665 (0%)
Transfusion: Prbcs	2/647 (0.3%)		1/665 (0.2%)
Platelets	4/647 (0.6%)		5/665 (0.8%)
Neutrophils/Granulocytes	16/647 (2.5%)		26/665 (3.9%)
Leukocytes	5/647 (0.8%)		0/665 (0%)
Lymphatics-Other	1/647 (0.2%)		0/665 (0%)
Cardiac disorders
Hypertension	1/647 (0.2%)		0/665 (0%)
Circulatory Or Cardiac-Other	1/647 (0.2%)		0/665 (0%)
Cardiac Left Ventricular Function	2/647 (0.3%)		1/665 (0.2%)
Hypotension	0/647 (0%)		2/665 (0.3%)
Sinus Tachycardia	1/647 (0.2%)		0/665 (0%)
Phlebitis	1/647 (0.2%)		0/665 (0%)
Vasovagal Episode	0/647 (0%)		1/665 (0.2%)
Supraventricular Arrhythmias	2/647 (0.3%)		1/665 (0.2%)
Thrombosis/Embolism	33/647 (5.1%)		16/665 (2.4%)
Cardiac-Ischemia/Infarction	3/647 (0.5%)		0/665 (0%)
Sinus Bradycardia	1/647 (0.2%)		0/665 (0%)
Eye disorders
Ocular-Other	0/647 (0%)		1/665 (0.2%)
Gastrointestinal disorders
Stomatitis/Pharyngitis	1/647 (0.2%)		0/665 (0%)
Gi-Other	5/647 (0.8%)		3/665 (0.5%)
Fistula-Intestinal	1/647 (0.2%)		1/665 (0.2%)
Duodenal Ulcer	0/647 (0%)		1/665 (0.2%)
Ileus	3/647 (0.5%)		3/665 (0.5%)
Gastritis	0/647 (0%)		1/665 (0.2%)
Mucositis Due To Radiation	0/647 (0%)		1/665 (0.2%)
Colitis	0/647 (0%)		2/665 (0.3%)
Fistula-Rectal/Anal	1/647 (0.2%)		1/665 (0.2%)
Dehydration	16/647 (2.5%)		9/665 (1.4%)
Constipation	2/647 (0.3%)		4/665 (0.6%)
Diarrhea (Without Colostomy)	9/647 (1.4%)		1/665 (0.2%)
Vomiting	13/647 (2%)		2/665 (0.3%)
Nausea	7/647 (1.1%)		3/665 (0.5%)
General disorders
Constitutional Symptoms-Other	1/647 (0.2%)		1/665 (0.2%)
Fever In The Absence Of Neutropenia	2/647 (0.3%)		1/665 (0.2%)
Fatigue	5/647 (0.8%)		1/665 (0.2%)
Chest Pain Non-Cardiac Or Non-Pleuritic	1/647 (0.2%)		4/665 (0.6%)
Rectal Or Perirectal Pain	0/647 (0%)		1/665 (0.2%)
Abdominal Pain Or Cramping	6/647 (0.9%)		4/665 (0.6%)
Pain-Other	0/647 (0%)		1/665 (0.2%)
Syndromes-Other	0/647 (0%)		1/665 (0.2%)
Hepatobiliary disorders
Hepatic-Other	0/647 (0%)		1/665 (0.2%)
Sgot	1/647 (0.2%)		1/665 (0.2%)
Immune system disorders
Allergic Reaction/Hypersensitivity	4/647 (0.6%)		3/665 (0.5%)
Infections and infestations
Infection, Other	3/647 (0.5%)		0/665 (0%)
Catheter-Related Infection	6/647 (0.9%)		1/665 (0.2%)
Infection With Unknown Anc	1/647 (0.2%)		1/665 (0.2%)
Infection Documented W Grd 3/4 Neutropn.	18/647 (2.8%)		9/665 (1.4%)
Infection Without Neutropenia	17/647 (2.6%)		8/665 (1.2%)
Febrile Neutropenia-Fuo Infect Not Docum	14/647 (2.2%)		14/665 (2.1%)
Metabolism and nutrition disorders
Hyponatremia	3/647 (0.5%)		0/665 (0%)
Hypocalcemia	2/647 (0.3%)		0/665 (0%)
Hyperglycemia	1/647 (0.2%)		2/665 (0.3%)
Hypokalemia	5/647 (0.8%)		2/665 (0.3%)
Hypomagnesmia	4/647 (0.6%)		0/665 (0%)
Musculoskeletal and connective tissue disorders
Muscle Weakness Not Due To Neuropathy	3/647 (0.5%)		1/665 (0.2%)
Nervous system disorders
Tremor	1/647 (0.2%)		0/665 (0%)
Neurologic-Other	1/647 (0.2%)		2/665 (0.3%)
Seizure(S)	1/647 (0.2%)		0/665 (0%)
Depressed Level Of Consciousness	0/647 (0%)		1/665 (0.2%)
Cns Cerebrovascular Ischemia	3/647 (0.5%)		1/665 (0.2%)
Confusion	0/647 (0%)		1/665 (0.2%)
Ataxia	0/647 (0%)		2/665 (0.3%)
Syncope	1/647 (0.2%)		1/665 (0.2%)
Mood Alteration-Anxiety Agitation	0/647 (0%)		1/665 (0.2%)
Mood Alteration-Depression	3/647 (0.5%)		0/665 (0%)
Neuropathy-Sensory	2/647 (0.3%)		1/665 (0.2%)
Neuropathy Motor	0/647 (0%)		2/665 (0.3%)
Renal and urinary disorders
Ureteral Obstruction	0/647 (0%)		3/665 (0.5%)
Fistula Or Gu Fistula	0/647 (0%)		1/665 (0.2%)
Renal Failure	0/647 (0%)		1/665 (0.2%)
Creatinine	4/647 (0.6%)		2/665 (0.3%)
Renal/Gu-Other	2/647 (0.3%)		1/665 (0.2%)
Respiratory, thoracic and mediastinal disorders
Pneumonitis/Pulmonary Infiltrates	1/647 (0.2%)		0/665 (0%)
Pleural Effusion (Non-Malignant)	0/647 (0%)		1/665 (0.2%)
Dyspnea	3/647 (0.5%)		4/665 (0.6%)
Pulmonary-Other	3/647 (0.5%)		1/665 (0.2%)
Pneumothorax	1/647 (0.2%)		1/665 (0.2%)
Hypoxia	0/647 (0%)		1/665 (0.2%)
Adult Respiratory Distress Syndrome	1/647 (0.2%)		0/665 (0%)
Skin and subcutaneous tissue disorders
Wound-Infectious	2/647 (0.3%)		3/665 (0.5%)
Skin-Other	1/647 (0.2%)		0/665 (0%)
Wound-Non-Infectious	1/647 (0.2%)		0/665 (0%)
Vascular disorders
Prothrombin Time	1/647 (0.2%)		0/665 (0%)
Melena/Gi Bleeding	3/647 (0.5%)		1/665 (0.2%)
Vaginal Bleeding	2/647 (0.3%)		1/665 (0.2%)
Rectal Bleeding/Hematochezia	1/647 (0.2%)		0/665 (0%)
Hemorrhage/Bleeding Without Grade 3 Or 4	1/647 (0.2%)		0/665 (0%)
Other (Not Including Serious) Adverse Events
	Arm I (Doxorubicin, Cisplatin, Paclitaxel)		Arm II (Paclitaxel, Carboplatin)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	631/647 (97.5%)		657/665 (98.8%)
Blood and lymphatic system disorders
Leukocytes	418/647 (64.6%)		556/665 (83.6%)
Neutrophils/Granulocytes	402/647 (62.1%)		590/665 (88.7%)
Platelets	244/647 (37.7%)		172/665 (25.9%)
Hemoglobin	445/647 (68.8%)		410/665 (61.7%)
Hematologic-Other	202/647 (31.2%)		156/665 (23.5%)
Blood and lymphatic system disorders	7/647 (1.1%)		3/665 (0.5%)
Cardiac disorders
Cardiac Left Ventricular Function	50/647 (7.7%)		0/665 (0%)
Cardiac disorders	55/647 (8.5%)		40/665 (6%)
Ear and labyrinth disorders
Ear and labyrinth disorders	26/647 (4%)		13/665 (2%)
Endocrine disorders
Endocrine disorders	11/647 (1.7%)		7/665 (1.1%)
Eye disorders
Eye disorders	46/647 (7.1%)		34/665 (5.1%)
Gastrointestinal disorders
All other GI	163/647 (25.2%)		125/665 (18.8%)
Nausea	218/647 (33.7%)		122/665 (18.3%)
Vomiting	165/647 (25.5%)		82/665 (12.3%)
Stomatitis/Pharyngitis	54/647 (8.3%)		17/665 (2.6%)
General disorders
Constitutional	37/647 (5.7%)		26/665 (3.9%)
Pain	91/647 (14.1%)		89/665 (13.4%)
myalgia	95/647 (14.7%)		97/665 (14.6%)
Hepatobiliary disorders
Hepatobiliary disorders	17/647 (2.6%)		17/665 (2.6%)
Immune system disorders
Allergic Reaction/Hypersensitivity	18/647 (2.8%)		29/665 (4.4%)
Infections and infestations
Infections and infestations	19/647 (2.9%)		8/665 (1.2%)
Febrile Neutropenia-Fuo Infect Not Docum	45/647 (7%)		37/665 (5.6%)
Infection Without Neutropenia	54/647 (8.3%)		25/665 (3.8%)
Metabolism and nutrition disorders
Metabolism and nutrition disorders	140/647 (21.6%)		96/665 (14.4%)
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorders	24/647 (3.7%)		20/665 (3%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (including cysts and polyps)	1/647 (0.2%)		3/665 (0.5%)
Nervous system disorders
Nervous system disorders	67/647 (10.4%)		47/665 (7.1%)
Neuropathy: sensory	163/647 (25.2%)		128/665 (19.2%)
Renal and urinary disorders
Renal and urinary disorders	15/647 (2.3%)		20/665 (3%)
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders	90/647 (13.9%)		82/665 (12.3%)
Skin and subcutaneous tissue disorders
Hair loss/alopecia (scalp or body)	473/647 (73.1%)		486/665 (73.1%)
Skin and subcutaneous tissue disorders	25/647 (3.9%)		12/665 (1.8%)
Vascular disorders
Vascular disorders	5/647 (0.8%)		4/665 (0.6%)
Vascular disorders	6/647 (0.9%)		7/665 (1.1%)

Limitations/Caveats

Eligibility for this study was expanded from measurable, stage 3 or stage 4 or recurrent disease to include non-measurable, stage 4 or recurrent disease and then to include non-measurable stage 3 disease.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.