Combination Chemotherapy With or Without Radiation Therapy in Treating Patients With Hodgkin's Lymphoma

• Sponsor: Eastern Cooperative Oncology Group (Other)
• Overall Status: Completed
• CT.gov ID: NCT00003389
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 854
• Locations: 539
• Arms: 2
• Duration (Months): 205
• Patients Per Site: 1.6
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer cells. Combining more than one drug with radiation therapy may kill more cancer cells. It is not yet known which combination chemotherapy regimen is most effective in treating Hodgkin's lymphoma.

PURPOSE: This randomized phase III trial is studying two different combination chemotherapy regimens and comparing how well they work, with or without radiation therapy, in treating patients with Hodgkin's lymphoma.

Condition or Disease	Intervention/Treatment	Phase
Lymphoma	Drug: Doxorubicin; Drug: Bleomycin; Drug: Vinblastine; Drug: Dacarbazine; Drug: Vincristine; Drug: Mechlorethamine; Drug: Etoposide; Drug: Prednisone; Drug: Cyclophosphamide; Radiation: Radiotherapy	Phase 3

Detailed Description

OBJECTIVES:

• Compare the failure-free survival of patients with locally extensive or advanced Hodgkin's lymphoma treated with doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD) vs doxorubicin, vinblastine, vincristine, bleomycin, mechlorethamine, etoposide, and prednisone (Stanford V) with or without radiotherapy.

• Compare the overall survival and freedom from progression in these patients at 5 and 10 years after treatment with these regimens.

• Compare pulmonary function, incidence of second cancers, reproductive function, and deaths from causes other than Hodgkin's lymphoma in patients treated with these regimens.

OUTLINE: This is a randomized study. Patients are stratified according to number of adverse risk factors (0-2 vs 3-7), disease characteristics (locally extensive vs advanced) and time of entry (before addendum 6 vs. after addendum 6). Patients are randomized to 1 of 2 treatment arms.

• Arm A (ABVD): Patients receive doxorubicin (25 mg/m²), bleomycin (10 u/m²), vinblastine (6 mg/m²), and dacarbazine (375 mg/m²) IV on days 1 and 15. Courses repeat every 28 days. Patients are restaged after 4 courses. Patients who are in complete remission receive 2 additional courses. Patients with a partial response or less are evaluated after 6 courses, and if there is an ongoing response, patients may receive 2 additional courses for a total of 8. If no ongoing response is observed, patients are removed from the study. All patients with massive mediastinal disease, regardless of stage, receive radiotherapy 2-3 weeks after completion of chemotherapy.

• Arm B (Stanford V): Patients receive Stanford V chemotherapy comprising doxorubicin (25 mg/m²) and vinblastine (6 mg/m²) IV on day 1 of weeks 1, 3, 5, 7, 9, and 11; vincristine (1.4 mg/m²) and bleomycin (5 u/m²) IV on day 1 of weeks 2, 4, 6, 8, 10, and 12; mechlorethamine (6 mg/m²) IV on day 1 of weeks 1, 5, and 9 (if mechlorethamine is unavailable, may substitute with cyclophosphamide [375 mg/m²] IV); etoposide (60 mg/m²) IV on days 1 and 2 of weeks 3, 7, and 11; and oral prednisone (40 mg/m²) every other day of weeks 1-9 followed by a taper. All patients with bulky disease receive radiotherapy 2-3 weeks after completion of chemotherapy.

Patients are followed every 2 months for 1 year, every 3 months for 1 year, every 4 months for 1 year, every 6 months for 2 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 850 patients will be accrued for this study within 4.3 years.

Study Design

• Study Type: Interventional
• Actual Enrollment: 854 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Randomized Phase III Trial of ABVD Versus Stanford V (+/-) Radiation Therapy in Locally Extensive and Advanced Stage Hodgkin's Disease
• Study Start Date: Apr 1, 1999
• Actual Primary Completion Date: Sep 1, 2011
• Actual Study Completion Date: May 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm A (ABVD) Arm A (ABVD): Patients receive doxorubicin (25 mg/m²), bleomycin (10 u/m²), vinblastine (6 mg/m²), and dacarbazine (375 mg/m²) intravenously (IV) on days 1 and 15. Courses repeat every 28 days. Patients are restaged after 4 courses. Patients who are in complete remission receive 2 additional courses. Patients with a partial response or less are evaluated after 6 courses, and if there is an ongoing response, patients may receive 2 additional courses for a total of 8. If no ongoing response is observed, patients are removed from the study. All patients with massive mediastinal disease, regardless of stage, receive radiotherapy 2-3 weeks after completion of chemotherapy.	Drug: Doxorubicin; given IV; Other Names: Adriamycin Rubex Adriamycin RDF Adriamycin PFS hydroxydaunorubicin hydroxydaunomycin ADR ; Drug: Bleomycin; given IV; Other Names: Blenoxane BLM Bleo ; Drug: Vinblastine; given IV; Other Names: Velban vinblastine sulfate vincaleukoblastine VLB Velsar Alkaban AQ ; Drug: Dacarbazine; given IV; Other Names: DTIC DTIC-Dome DIC imidazole carboxamide dimethyl triazeno imidazole carboxamide ; Radiation: Radiotherapy
Active Comparator: Arm B (Stanford V) Arm B (Stanford V): Patients receive Stanford V chemotherapy comprising doxorubicin (25 mg/m²) and vinblastine (6 mg/m²) IV on day 1 of weeks 1, 3, 5, 7, 9, and 11; vincristine (1.4 mg/m²) and bleomycin (5 u/m²) IV on day 1 of weeks 2, 4, 6, 8, 10, and 12; mechlorethamine (6 mg/m²) IV on day 1 of weeks 1, 5, and 9 (if mechlorethamine is unavailable, may substitute with cyclophosphamide [375 mg/m²] IV); etoposide (60 mg/m²) IV on days 1 and 2 of weeks 3, 7, and 11; and oral prednisone (40 mg/m²) every other day of weeks 1-9 followed by a taper. All patients with bulky disease receive radiotherapy 2-3 weeks after completion of chemotherapy.	Drug: Doxorubicin; given IV; Other Names: Adriamycin Rubex Adriamycin RDF Adriamycin PFS hydroxydaunorubicin hydroxydaunomycin ADR ; Drug: Bleomycin; given IV; Other Names: Blenoxane BLM Bleo ; Drug: Vinblastine; given IV; Other Names: Velban vinblastine sulfate vincaleukoblastine VLB Velsar Alkaban AQ ; Drug: Vincristine; given IV; Other Names: Oncovin Vincasar PFS vincristine sulfate VCR leurocristine LCR ; Drug: Mechlorethamine; given IV; Other Names: Mustargen nitrogen mustard ; Drug: Etoposide; given IV; Other Names: VP-16 VePesid VP-16-213 EPEG epipodophyllotoxin ; Drug: Prednisone; taken orally; Other Names: Deltasone Orasone Medicorten Panasol-S Liquid-Pred ; Drug: Cyclophosphamide; given IV; Other Names: Cytoxan Neosar CTX CPM ; Radiation: Radiotherapy

Outcome Measures

Primary Outcome Measures

1. Failure-free Survival at 5 Years [Assessed every 2 months if patient is < 1 year from study entry, every 3 months for the second year, every 4 months for the third year, every 6 months for years 4 and 5]

   Failure-free survival is defined as the time from randomization to the earlier of progression/relapse or death. The 5-year failure-free survival is the probability a patient is failure-free and survives 5 years. Progression is defined as an increase in size of 25% of the sum of the products of the pretreatment measurements or appearance of new lesions. Significant enlargement of the liver or spleen is evidence of progression. A significant increase in size is defined as > 2.0 cm in distance between costal margin and the inferior margin of either organ. Relapse is defined as the re-appearance of any clinical evidence of Hodgkin's disease in a patient who has had a complete response. Relapse for partial responders is defined as progressive disease relative to disease status during the partial remission.

Secondary Outcome Measures

1. 5-year Overall Survival [Assessed every 2 months if patient is < 1 year from study entry, every 3 months for the second year, every 4 months for the third year, every 6 months for years 4 and 5, and yearly for 5 years]

   Overall survival is defined as the time from randomization to death or last known alive. The 5-year survival rate is the probability a patient survives 5 years.

2. Incidence of Second Cancers [Assessed every 2 months if patient is < 1 year from study entry, every 3 months for the second year, every 4 months for the third year, every 6 months for years 4 and 5, and yearly for 5 years]

   Number of patients who developed second primary cancers

Eligibility Criteria

Criteria

• Ages Eligible for Study: 16 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion criteria:

• Histologically proven previously untreated classical Hodgkin's lymphoma

• The following stages are eligible:

• Locally extensive: Stage I-IIA/B with massive mediastinal adenopathy

• Advanced: Stage III or IV

• Measurable or evaluable disease

• Age of 16 and over

• ECOG Performance status 0-2

• Disease-free of prior invasive malignancies for >5 years with the exception of curatively-treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix

• White blood cell (WBC) at least 4,000/mm³, (unless documented bone marrow involvement)

• Platelet count at least 100,000/mm³ (unless documented bone marrow involvement)

• Bilirubin no greater than 5.0 mg/dL

• Creatinine no greater than 2.0 mg/dL

• Ejection fraction determination recommended if over age 50 and/or have a history of cardiac disease

• Fertile patients must use effective contraception

• Prior corticosteroids allowed

• Prior surgery allowed

Exclusion criteria:

• Pregnant or nursing

• Prior radiotherapy

• Prior chemotherapy

• Human immunodeficiency virus (HIV) positive

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mobile Infirmary Medical Center	Mobile	Alabama	United States	36652-2144
2	CCOP - Western Regional, Arizona	Phoenix	Arizona	United States	85006
3	St. Joseph's Hospital and Medical Center	Phoenix	Arizona	United States	85013
4	Arizona Cancer Center at University of Arizona Health Sciences Center	Tucson	Arizona	United States	85724-5024
5	Alta Bates Comprehensive Cancer Center	Berkeley	California	United States	94704
6	Peninsula Medical Center	Burlingame	California	United States	94010
7	Eden Medical Center	Castro Valley	California	United States	94546
8	Mount Diablo Regional Cancer Center	Concord	California	United States	94524-4110
9	North Bay Cancer Center	Fairfield	California	United States	94533
10	Kaiser Permanente - Fremont	Fremont	California	United States	94538
11	Marin Cancer Institute at Marin General Hospital	Greenbrae	California	United States	94904
12	Sutter Health - Western Division Cancer Research Group	Greenbrae	California	United States	94904
13	Kaiser Permanente Medical Center - Hayward	Hayward	California	United States	94545
14	Saint Rose Hospital	Hayward	California	United States	94545
15	Moores UCSD Cancer Center	La Jolla	California	United States	92093-0658
16	Memorial Medical Center Cancer Services	Modesto	California	United States	95355
17	Highland General Hospital at St. George's University School of Medicine	Oakland	California	United States	94602
18	Alta Bates Summit Medical Center - Summit Campus	Oakland	California	United States	94609
19	CCOP - Bay Area Tumor Institute	Oakland	California	United States	94609
20	Kaiser Permanente Medical Center - Oakland	Oakland	California	United States	94611
21	Valley Care Medical Center	Pleasanton	California	United States	94588
22	Kaiser Permanente Medical Center - Redwood City	Redwood City	California	United States	94063
23	Kaiser Permanente Medical Center - Richmond	Richmond	California	United States	94801
24	Kaiser Permanente Medical Center - Roseville	Roseville	California	United States	95661
25	Sutter Cancer Center at Roseville Medical Center	Roseville	California	United States	95661
26	Sutter Cancer Center	Sacramento	California	United States	95816
27	University of California Davis Cancer Center	Sacramento	California	United States	95817
28	South Sacramento Kaiser-Permanente Medical Center	Sacramento	California	United States	95823
29	Kaiser Permanente Medical Center - Sacramento	Sacramento	California	United States	95825
30	Salinas Valley Memorial Hospital	Salinas	California	United States	93901
31	Kaiser Permanente Medical Office -Vandever Medical Office	San Diego	California	United States	92120
32	Veterans Affairs Medical Center - San Diego	San Diego	California	United States	92161
33	Kaiser Permanente Medical Center - San Francisco Geary Campus	San Francisco	California	United States	94115
34	California Pacific Medical Center - California Campus	San Francisco	California	United States	94118
35	Kaiser Permanente Medical Center - Santa Teresa	San Jose	California	United States	95119
36	J.C. Robinson, M.D. Regional Cancer Center	San Pablo	California	United States	94806
37	Kaiser Foundation Hospital - San Rafael	San Rafael	California	United States	94903
38	Kaiser Permanente Medical Center - Santa Clara Kiely Campus	Santa Clara	California	United States	95051
39	Kaiser Permanente Medical Center - Santa Rosa	Santa Rosa	California	United States	95403
40	Kaiser Permanente Medical Center - South San Francisco	South San Francisco	California	United States	94080
41	Kaiser Permanente Medical Facility - Stockton	Stockton	California	United States	95210
42	Kaiser Permanente Medical Center - Vallejo	Vallejo	California	United States	94589
43	Sutter Solano Medical Center	Vallejo	California	United States	94589
44	Kaiser Permanente Medical Center - Walnut Creek	Walnut Creek	California	United States	94596
45	John Muir/Mt. Diablo Comprehensive Cancer Center	Walnut Creek	California	United States	94598
46	Aurora Presbyterian Hospital	Aurora	Colorado	United States	80012
47	Boulder Community Hospital	Boulder	Colorado	United States	80301-9019
48	Memorial Hospital	Colorado Springs	Colorado	United States	80909
49	Penrose Cancer Center at Penrose Hospital	Colorado Springs	Colorado	United States	80933
50	Porter Adventist Hospital	Denver	Colorado	United States	80210
51	Presbyterian - St. Luke's Medical Center	Denver	Colorado	United States	80218
52	St. Joseph Hospital	Denver	Colorado	United States	80218
53	Rose Medical Center	Denver	Colorado	United States	80220
54	CCOP - Colorado Cancer Research Program, Incorporated	Denver	Colorado	United States	80224-2522
55	Swedish Medical Center	Englewood	Colorado	United States	80110
56	Front Range Cancer Specialists	Fort Collins	Colorado	United States	80524
57	Poudre Valley Hospital	Fort Collins	Colorado	United States	80524
58	Sky Ridge Medical Center	Lone Tree	Colorado	United States	80124
59	Hope Cancer Care Center at Longmont United Hospital	Longmont	Colorado	United States	80502
60	St. Mary-Corwin Regional Medical Center	Pueblo	Colorado	United States	81004
61	North Suburban Medical Center	Thornton	Colorado	United States	80229
62	Beebe Medical Center	Lewes	Delaware	United States	19958
63	CCOP - Christiana Care Health Services	Newark	Delaware	United States	19713
64	St. Francis Hospital	Wilmington	Delaware	United States	19805
65	Lombardi Comprehensive Cancer Center at Georgetown University Medical Center	Washington, D.C.	District of Columbia	United States	20007
66	Walter Reed Army Medical Center	Washington, D.C.	District of Columbia	United States	20307-5001
67	Michael & Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital	Fort Lauderdale	Florida	United States	33308
68	Broward General Medical Center Cancer Center	Fort Lauderdale	Florida	United States	33316
69	Memorial Cancer Institute at Memorial Regional Hospital	Hollywood	Florida	United States	33021
70	Mayo Clinic - Jacksonville	Jacksonville	Florida	United States	32224
71	Ella Milbank Foshay Cancer Center at Jupiter Medical Center	Jupiter	Florida	United States	33458
72	CCOP - Mount Sinai Medical Center	Miami Beach	Florida	United States	33140
73	University of Miami Sylvester Comprehensive Cancer Center	Miami	Florida	United States	33136
74	M.D. Anderson Cancer Center - Orlando	Orlando	Florida	United States	32806
75	Piedmont Hospital	Atlanta	Georgia	United States	30309
76	Winship Cancer Institute of Emory University	Atlanta	Georgia	United States	30322
77	Northside Hospital Cancer Center	Atlanta	Georgia	United States	30342-1611
78	Saint Joseph's Hospital of Atlanta	Atlanta	Georgia	United States	30342-1701
79	CCOP - Atlanta Regional	Atlanta	Georgia	United States	30342
80	WellStar Cobb Hospital	Austell	Georgia	United States	30106
81	Charles B. Eberhart Cancer Center at DeKalb Medical Center	Decatur	Georgia	United States	30033
82	Veterans Affairs Medical Center - Atlanta (Decatur)	Decatur	Georgia	United States	30033
83	Gwinnett Medical Center	Lawrenceville	Georgia	United States	30045
84	Kennestone Cancer Center at Wellstar Kennestone Hospital	Marietta	Georgia	United States	30060
85	Southern Regional Medical Center	Riverdale	Georgia	United States	30274-2600
86	Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center	Savannah	Georgia	United States	31403-3089
87	Tripler Army Medical Center	Honolulu	Hawaii	United States	96859
88	Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center	Boise	Idaho	United States	83706
89	St. Luke's Mountain States Tumor Institute - Boise	Boise	Idaho	United States	83712
90	Saint Anthony's Hospital at Saint Anthony's Health Center	Alton	Illinois	United States	62002
91	Rush-Copley Cancer Care Center	Aurora	Illinois	United States	60507
92	St. Joseph Medical Center	Bloomington	Illinois	United States	61701
93	Graham Hospital	Canton	Illinois	United States	61520
94	Memorial Hospital	Carthage	Illinois	United States	62321
95	Robert H. Lurie Comprehensive Cancer Center at Northwestern University	Chicago	Illinois	United States	60611-3013
96	Hematology and Oncology Associates	Chicago	Illinois	United States	60611
97	Veterans Affairs Medical Center - Lakeside Chicago	Chicago	Illinois	United States	60611
98	Rush University Medical Center	Chicago	Illinois	United States	60612
99	Mercy Hospital and Medical Center	Chicago	Illinois	United States	60616
100	Swedish Covenant Hospital	Chicago	Illinois	United States	60625
101	University of Chicago Cancer Research Center	Chicago	Illinois	United States	60637-1470
102	Decatur Memorial Hospital Cancer Care Institute	Decatur	Illinois	United States	62526
103	Eureka Community Hospital	Eureka	Illinois	United States	61530
104	Evanston Northwestern Health Care - Evanston Hospital	Evanston	Illinois	United States	60201-1781
105	Galesburg Clinic	Galesburg	Illinois	United States	61401
106	Galesburg Cottage Hospital	Galesburg	Illinois	United States	61401
107	InterCommunity Cancer Center of Western Illinois	Galesburg	Illinois	United States	61401
108	Ingalls Cancer Care Center at Ingalls Memorial Hospital	Harvey	Illinois	United States	60426
109	Mason District Hospital	Havana	Illinois	United States	62644
110	Hinsdale Hematology Oncology Associates	Hinsdale	Illinois	United States	60521
111	Hopedale Medical Complex	Hopedale	Illinois	United States	61747
112	Midwest Center for Hematology/Oncology	Joliet	Illinois	United States	60432
113	Joliet Oncology-Hematology Associates, Limited - West	Joliet	Illinois	United States	60435
114	Kewanee Hospital	Kewanee	Illinois	United States	61443
115	North Shore Oncology and Hematology Associates, Limited - Libertyville	Libertyville	Illinois	United States	60048
116	McDonough District Hospital	Macomb	Illinois	United States	61455
117	Cardinal Bernardin Cancer Center at Loyola University Medical Center	Maywood	Illinois	United States	60153
118	Trinity Medical Center - East	Moline	Illinois	United States	61265
119		Moline	Illinois	United States	61265
120	Good Samaritan Regional Health Center	Mount Vernon	Illinois	United States	62864
121	Edward Hospital Cancer Center	Naperville	Illinois	United States	60540
122	Hematology Oncology Consultants - Naperville	Naperville	Illinois	United States	60540
123	Northwest Medical Specialist, PC	Niles	Illinois	United States	60714
124	BroMenn Regional Medical Center	Normal	Illinois	United States	61761
125	Community Cancer Center	Normal	Illinois	United States	61761
126	Community Hospital of Ottawa	Ottawa	Illinois	United States	61350
127	Oncology Hematology Associates of Central Illinois, PC - Ottawa	Ottawa	Illinois	United States	61350
128	Cancer Treatment Center at Pekin Hospital	Pekin	Illinois	United States	61554
129	Proctor Hospital	Peoria	Illinois	United States	61614
130	CCOP - Illinois Oncology Research Association	Peoria	Illinois	United States	61615
131	Oncology Hematology Associates of Central Illinois, PC - Peoria	Peoria	Illinois	United States	61615
132	Methodist Medical Center of Illinois	Peoria	Illinois	United States	61636
133	OSF St. Francis Medical Center	Peoria	Illinois	United States	61637
134	Illinois Valley Community Hospital	Peru	Illinois	United States	61354
135	Perry Memorial Hospital	Princeton	Illinois	United States	61356
136	Swedish-American Regional Cancer Center	Rockford	Illinois	United States	61104-2315
137	Hematology Oncology Associates - Skokie	Skokie	Illinois	United States	60076
138	Hematology/Oncology of the North Shore at Gross Point Medical Center	Skokie	Illinois	United States	60076
139	Midwest Cancer Research Group, Incorporated	Skokie	Illinois	United States	60077
140	St. Margaret's Hospital	Spring Valley	Illinois	United States	61362
141	Valley Cancer Center	Spring Valley	Illinois	United States	61362
142	Carle Cancer Center at Carle Foundation Hospital	Urbana	Illinois	United States	61801
143	CCOP - Carle Cancer Center	Urbana	Illinois	United States	61801
144	St. Francis Hospital and Health Centers - Beech Grove Campus	Beech Grove	Indiana	United States	46107
145	Elkhart General Hospital	Elkhart	Indiana	United States	46515
146	Fort Wayne Medical Oncology and Hematology	Fort Wayne	Indiana	United States	46815
147	Howard Community Hospital at Howard Regional Health System	Kokomo	Indiana	United States	46904
148	Center for Cancer Therapy at LaPorte Hospital and Health Services	La Porte	Indiana	United States	46350
149	Saint Anthony Memorial Health Centers	Michigan City	Indiana	United States	46360
150	Medical Consultants, P. C. at Ball Cancer Center	Muncie	Indiana	United States	47303
151	Reid Hospital & Health Care Services, Incorporated	Richmond	Indiana	United States	47374
152	CCOP - Northern Indiana CR Consortium	South Bend	Indiana	United States	46601
153	Memorial Hospital of South Bend	South Bend	Indiana	United States	46601
154	Saint Joseph Regional Medical Center	South Bend	Indiana	United States	46617
155	McFarland Clinic, P. C.	Ames	Iowa	United States	50010
156		Bettendorf	Iowa	United States	52722
157	St. Luke's Hospital	Cedar Rapids	Iowa	United States	52402
158	Cedar Rapids Oncology Associates	Cedar Rapids	Iowa	United States	52403
159	Mercy Regional Cancer Center at Mercy Medical Center	Cedar Rapids	Iowa	United States	52403
160	Genesis Regional Cancer Center at Genesis Medical Center	Davenport	Iowa	United States	52803
161	Genesis Medical Center - West Campus	Davenport	Iowa	United States	52804
162	Mercy Capitol Hospital	Des Moines	Iowa	United States	50307
163	CCOP - Iowa Oncology Research Association	Des Moines	Iowa	United States	50309
164	John Stoddard Cancer Center at Iowa Methodist Medical Center	Des Moines	Iowa	United States	50309
165	Medical Oncology and Hematology Associates at John Stoddard Cancer Center	Des Moines	Iowa	United States	50309
166	Medical Oncology and Hematology Associates at Mercy Cancer Center	Des Moines	Iowa	United States	50314
167	Mercy Cancer Center at Mercy Medical Center - Des Moines	Des Moines	Iowa	United States	50314
168	John Stoddard Cancer Center at Iowa Lutheran Hospital	Des Moines	Iowa	United States	50316-2301
169	Holden Comprehensive Cancer Center at University of Iowa	Iowa City	Iowa	United States	52242
170	Burgess Health Center	Onawa	Iowa	United States	51040
171	Siouxland Hematology-Oncology Associates	Sioux City	Iowa	United States	51101
172	Siouxland Regional Cancer Center	Sioux City	Iowa	United States	51101
173	Mercy Medical Center - Sioux City	Sioux City	Iowa	United States	51104
174	St. Luke's Regional Medical Center	Sioux City	Iowa	United States	51104
175	Medical Oncology and Hematology Associates - West Des Moines	West Des Moines	Iowa	United States	50266
176	Cancer Center of Kansas, P.A. - Chanute	Chanute	Kansas	United States	66720
177	Cancer Center of Kansas, PA - Dodge City	Dodge City	Kansas	United States	67801
178	Cancer Center of Kansas, P.A. - El Dorado	El Dorado	Kansas	United States	67042
179	Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center	Kansas City	Kansas	United States	66160-7357
180	Cancer Center of Kansas, P.A. - Kingman	Kingman	Kansas	United States	67068
181	Southwest Medical Center	Liberal	Kansas	United States	67901
182	Cancer Center of Kansas, P.A. - Newton	Newton	Kansas	United States	67114
183	Cancer Center of Kansas, P.A. - Parsons	Parsons	Kansas	United States	67357
184	Cancer Center of Kansas, P.A. - Pratt	Pratt	Kansas	United States	67124
185	Cancer Center of Kansas, P.A. - Salina	Salina	Kansas	United States	67042
186	Salina Regional Health Center	Salina	Kansas	United States	67401
187	Stormont-Vail Cancer Center	Topeka	Kansas	United States	66604
188	St. Francis Comprehensive Cancer Center	Topeka	Kansas	United States	66606
189	Cancer Center of Kansas, P.A. - Wellington	Wellington	Kansas	United States	67152
190	Associates in Womens Health, P.A. - North Review	Wichita	Kansas	United States	67203
191	Cancer Center of Kansas, P.A. - Medical Arts Tower	Wichita	Kansas	United States	67208
192	Cancer Center of Kansas, P.A. - Wichita	Wichita	Kansas	United States	67214
193	CCOP - Wichita	Wichita	Kansas	United States	67214
194	Via Christi Cancer Center at Via Christi Regional Medical Center	Wichita	Kansas	United States	67214
195	Wesley Medical Center	Wichita	Kansas	United States	67214
196	Cancer Center of Kansas, P.A. - Winfield	Winfield	Kansas	United States	67156
197	James Graham Brown Cancer Center at University of Louisville	Louisville	Kentucky	United States	40202
198	Pennington Cancer Center at Baton Rouge General	Baton Rouge	Louisiana	United States	70806
199	Mary Bird Perkins Cancer Center - Baton Rouge	Baton Rouge	Louisiana	United States	70809
200	Ochsner Clinic of Baton Rouge	Baton Rouge	Louisiana	United States	708169990
201	Terrebonne General Medical Center	Houma	Louisiana	United States	70360
202	Louisiana State University Health Sciences Center - Monroe	Monroe	Louisiana	United States	71210
203	MBCCOP - LSU Health Sciences Center	New Orleans	Louisiana	United States	70112
204	Medical Center of Louisiana - New Orleans	New Orleans	Louisiana	United States	70112
205	CCOP - Ochsner	New Orleans	Louisiana	United States	70121
206	Ochsner Cancer Institute at Ochsner Clinic Foundation	New Orleans	Louisiana	United States	70121
207	Veterans Affairs Medical Center - Shreveport	Shreveport	Louisiana	United States	71101
208	Feist-Weiller Cancer Center at Louisiana State University Health Sciences	Shreveport	Louisiana	United States	71130-3932
209	CancerCare of Maine at Eastern Maine Medial Center	Bangor	Maine	United States	04401
210	Greenebaum Cancer Center at University of Maryland Medical Center	Baltimore	Maryland	United States	21201
211	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Baltimore	Maryland	United States	21231-2410
212	Union Hospital Cancer Center at Union Hospital	Elkton	Maryland	United States	21921
213	Sturdy Memorial Hospital	Attleboro	Massachusetts	United States	02703
214	Tufts - New England Medical Center	Boston	Massachusetts	United States	02111
215	Cancer Research Center at Boston Medical Center	Boston	Massachusetts	United States	02118
216	Franklin Medical Center	Greenfield	Massachusetts	United States	01301
217	Baystate Regional Cancer Program at D'Amour Center for Cancer Care	Springfield	Massachusetts	United States	01199
218	Hickman Cancer Center at Bixby Medical Center	Adrian	Michigan	United States	49221
219	St. Joseph Mercy Cancer Center at St. Joseph Mercy Hospital	Ann Arbor	Michigan	United States	48106-0995
220	CCOP - Michigan Cancer Research Consortium	Ann Arbor	Michigan	United States	48106
221	University of Michigan Comprehensive Cancer Center	Ann Arbor	Michigan	United States	48109-0942
222	Battle Creek Health System Cancer Care Center	Battle Creek	Michigan	United States	49017
223	Bay Regional Medical Center	Bay City	Michigan	United States	48708
224	Mecosta County Medical Center	Big Rapids	Michigan	United States	49307
225	Oakwood Cancer Center at Oakwood Hospital and Medical Center	Dearborn	Michigan	United States	48123-2500
226	Josephine Ford Cancer Center at Henry Ford Hospital	Detroit	Michigan	United States	48202
227	Green Bay Oncology, Limited - Escanaba	Escanaba	Michigan	United States	49431
228	Genesys Hurley Cancer Institute	Flint	Michigan	United States	48503
229	Hurley Medical Center	Flint	Michigan	United States	48503
230	CCOP - Grand Rapids	Grand Rapids	Michigan	United States	49503
231	Lacks Cancer Center at Saint Mary's Mercy Medical Center	Grand Rapids	Michigan	United States	49503
232	Spectrum Health Cancer Care - Butterworth Campus	Grand Rapids	Michigan	United States	49503
233	Metropolitan Hospital	Grand Rapids	Michigan	United States	49506
234	Van Elslander Cancer Center at St. John Hospital and Medical Center	Grosse Pointe Woods	Michigan	United States	48236
235	Holland Community Hospital	Holland	Michigan	United States	49423
236	Green Bay Oncology, Limited - Iron Mountain	Iron Mountain	Michigan	United States	49801
237	Foote Hospital	Jackson	Michigan	United States	49201
238	Borgess Medical Center	Kalamazoo	Michigan	United States	49001
239	West Michigan Cancer Center	Kalamazoo	Michigan	United States	49007-3731
240	Bronson Methodist Hospital	Kalamazoo	Michigan	United States	49007
241	Haematology-Oncology Associates of Ohio and Michigan, P.C.	Lambertville	Michigan	United States	48144
242	Sparrow Regional Cancer Center	Lansing	Michigan	United States	48909
243	Breslin Cancer Center at Ingham Regional Medical Center	Lansing	Michigan	United States	48910
244	Upper Michigan Cancer Center at Marquette General Hospital	Marquette	Michigan	United States	49855
245	Community Cancer Center of Monroe	Monroe	Michigan	United States	48162
246	Mercy Memorial Hospital System	Monroe	Michigan	United States	48162
247	Hackley Hospital	Muskegon	Michigan	United States	49443
248	Northern Michigan Hospital	Petoskey	Michigan	United States	49770
249	William Beaumont Hospital - Royal Oak Campus	Royal Oak	Michigan	United States	48073
250	Seton Cancer Institute - Saginaw	Saginaw	Michigan	United States	48601
251	Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph	Saint Joseph	Michigan	United States	49085
252	Providence Cancer Institute at Providence Hospital - Southfield Campus	Southfield	Michigan	United States	48075
253	Munson Medical Center	Traverse City	Michigan	United States	49684
254	St. John Macomb Hospital	Warren	Michigan	United States	48093
255		Alexandria	Minnesota	United States	56308
256	MeritCare Clinic - Bemidji	Bemidji	Minnesota	United States	56601
257	Brainerd Medical Center	Brainerd	Minnesota	United States	56401
258	St. Joseph's Medical Center	Brainerd	Minnesota	United States	56401
259	Fairview Ridges Hospital	Burnsville	Minnesota	United States	55337
260	Mercy and Unity Cancer Center at Mercy Hospital	Coon Rapids	Minnesota	United States	55433
261	Fairview Southdale Hospital	Edina	Minnesota	United States	55435
262		Fergus Falls	Minnesota	United States	56537
263	Mercy and Unity Cancer Center at Unity Hospital	Fridley	Minnesota	United States	55432
264	Virginia Piper Cancer Institute at Abbott-Northwestern Hospital	Minneapolis	Minnesota	United States	55407
265	Chippewa County - Montevideo Hospital	Montevideo	Minnesota	United States	56265
266	Hubert H. Humphrey Cancer Center at North Memorial Medical Center	Robbinsdale	Minnesota	United States	55422-2900
267	Mayo Clinic Cancer Center	Rochester	Minnesota	United States	55905
268	CentraCare Clinic - River Campus	Saint Cloud	Minnesota	United States	56303
269	Coborn Cancer Center	Saint Cloud	Minnesota	United States	56303
270	CCOP - Metro-Minnesota	Saint Louis Park	Minnesota	United States	55416
271	Park Nicollet Health Services	Saint Louis Park	Minnesota	United States	55416
272	United Hospital	Saint Paul	Minnesota	United States	55102
273	Ridgeview Medical Center	Waconia	Minnesota	United States	55387
274	Hattiesburg Clinic, P.A.	Hattiesburg	Mississippi	United States	39401
275	University of Mississippi Medical Center	Jackson	Mississippi	United States	39216-4505
276	Saint Francis Medical Center	Cape Girardeau	Missouri	United States	63701
277	Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital	Cape Girardeau	Missouri	United States	63701
278	Ellis Fischel Cancer Center at University of Missouri - Columbia	Columbia	Missouri	United States	65203
279	Siteman Cancer Center at Barnes-Jewish Hospital	Saint Louis	Missouri	United States	63110
280	CCOP - St. Louis-Cape Girardeau	Saint Louis	Missouri	United States	63141
281	David C. Pratt Cancer Center at St. John's Mercy	Saint Louis	Missouri	United States	63141
282	CCOP - Cancer Research for the Ozarks	Springfield	Missouri	United States	65802
283	St. John's Regional Health Center	Springfield	Missouri	United States	65804
284	Hulston Cancer Center at Cox Medical Center South	Springfield	Missouri	United States	65807
285	CCOP - Montana Cancer Consortium	Billings	Montana	United States	59101
286	Hematology-Oncology Centers of the Northern Rockies - Billings	Billings	Montana	United States	59101
287	Northern Rockies Radiation Oncology Center	Billings	Montana	United States	59101
288	St. Vincent Healthcare	Billings	Montana	United States	59101
289	Deaconess Billings Clinic Cancer Center	Billings	Montana	United States	59107-5100
290	Deaconess Billings Clinic - Downtown	Billings	Montana	United States	59107-7000
291	Bozeman Deaconess Hospital	Bozeman	Montana	United States	59715
292	Internal Medicine Associates of Bozeman	Bozeman	Montana	United States	59715
293	St. James Community Hospital	Butte	Montana	United States	59701
294	Big Sky Oncology	Great Falls	Montana	United States	59405
295	Great Falls Clinic	Great Falls	Montana	United States	59405
296	Sletten Regional Cancer Institute	Great Falls	Montana	United States	59405
297	St. Peter's Hospital	Helena	Montana	United States	59601
298	Glacier Oncology, PLLC	Kalispell	Montana	United States	59901
299	Kalispell Medical Oncology	Kalispell	Montana	United States	59901
300	Kalispell Regional Medical Center	Kalispell	Montana	United States	59901
301	Community Medical Center	Missoula	Montana	United States	59801
302	Montana Cancer Specialists at Montana Cancer Center	Missoula	Montana	United States	59807-7877
303	Montana Cancer Center at St. Patrick Hospital and Health Sciences Center	Missoula	Montana	United States	59807
304	Saint Francis Cancer Treatment Center at Saint Francis Memorial Health Center	Grand Island	Nebraska	United States	68803
305	Bryan LGH Medical Center West	Lincoln	Nebraska	United States	68502
306	St. Elizabeth Regional Medical Center	Lincoln	Nebraska	United States	68510
307	Great Plains Regional Medical Center	North Platte	Nebraska	United States	69101-6598
308	Immanuel Medical Center	Omaha	Nebraska	United States	68122
309	Bergan Mercy Medical Center	Omaha	Nebraska	United States	68124
310	Creighton University Medical Center	Omaha	Nebraska	United States	68131-2197
311	UNMC Eppley Cancer Center at the University of Nebraska Medical Center	Omaha	Nebraska	United States	68198-6805
312	University Medical Center of Southern Nevada	Las Vegas	Nevada	United States	89102
313	CCOP - Nevada Cancer Research Foundation	Las Vegas	Nevada	United States	89106
314	New Hampshire Oncology-Hematology, PA - Hooksett	Hooksett	New Hampshire	United States	03106
315	Kingsbury Center for Cancer Care at Cheshire Medical Center	Keene	New Hampshire	United States	03431
316	Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire	United States	03756-0002
317	Elliot Regional Cancer Center	Manchester	New Hampshire	United States	03103
318	Frisbie Memorial Hospital	Rochester	New Hampshire	United States	03867
319	Cancer Institute of New Jersey at Hamilton	Hamilton	New Jersey	United States	08690
320	St. Barnabas Medical Center	Livingston	New Jersey	United States	07039
321	Fox Chase Virtua Health Cancer Program - Marlton	Marlton	New Jersey	United States	08053
322	Mountainside Hospital Cancer Center	Montclair	New Jersey	United States	07042
323	Carol G. Simon Cancer Center at Morristown Memorial Hospital	Morristown	New Jersey	United States	07962
324	Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School	New Brunswick	New Jersey	United States	08903
325	Booker Cancer Center at Riverview Medical Center	Red Bank	New Jersey	United States	07701
326	Fox Chase Cancer Center at St. Francis Medical Center	Trenton	New Jersey	United States	08629
327	Cancer Institute of New Jersey at Cooper - Voorhees	Voorhees	New Jersey	United States	08043
328	Fox Chase Virtua Health Cancer Program at Virtua West Jersey	Voorhees	New Jersey	United States	08043
329	University of New Mexico Cancer Research and Treatment Center	Albuquerque	New Mexico	United States	87131-5636
330	Finger Lakes Hematology and Oncology	Clifton Springs	New York	United States	14432
331	Adirondack Cancer Care - Glens Falls	Glens Falls	New York	United States	12801
332	Charles R. Wood Cancer Center at Glens Falls Hospital	Glens Falls	New York	United States	12801
333	St. Vincent's Comprehensive Cancer Center - Manhattan	New York	New York	United States	10011
334	Memorial Sloan-Kettering Cancer Center	New York	New York	United States	10021
335	Oswego Hospital	Oswego	New York	United States	13126
336	Highland Hospital of Rochester	Rochester	New York	United States	14620
337	James P. Wilmot Cancer Center at University of Rochester Medical Center	Rochester	New York	United States	14642
338	CCOP - Hematology-Oncology Associates of Central New York	Syracuse	New York	United States	13057
339	SUNY Upstate Medical University Hospital	Syracuse	New York	United States	13210
340	Community General Hospital of Greater Syracuse	Syracuse	New York	United States	13215
341	Albert Einstein Cancer Center at Albert Einstein College of Medicine	The Bronx	New York	United States	10461
342	Our Lady of Mercy Medical Center Comprehensive Cancer Center	The Bronx	New York	United States	10466
343	Mission Hospitals - Memorial Campus	Asheville	North Carolina	United States	28801
344	Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill	Chapel Hill	North Carolina	United States	27599-7295
345	Blumenthal Cancer Center at Carolinas Medical Center	Charlotte	North Carolina	United States	28232-2861
346	Wayne Memorial Hospital, Incorporated	Goldsboro	North Carolina	United States	27534
347	Wayne Radiation Oncology	Goldsboro	North Carolina	United States	27534
348	Leo W. Jenkins Cancer Center at Pitt County Memorial Hospital	Greenville	North Carolina	United States	27835-6028
349	Lenoir Memorial Cancer Center	Kinston	North Carolina	United States	28501
350	Iredell Memorial Hospital	Statesville	North Carolina	United States	28677
351	Wilson Medical Center	Wilson	North Carolina	United States	27893-3428
352	Forsyth Regional Cancer Center at Forsyth Medical Center	Winston-Salem	North Carolina	United States	27103
353	Wake Forest University Comprehensive Cancer Center	Winston-Salem	North Carolina	United States	27157-1096
354	Bismarck Cancer Center	Bismarck	North Dakota	United States	58501
355	Cancer Care Center at Medcenter One Hospital	Bismarck	North Dakota	United States	58501
356	Mid Dakota Clinic, P. C.	Bismarck	North Dakota	United States	58501
357	St. Alexius Medical Center	Bismarck	North Dakota	United States	58502
358	CCOP - MeritCare Hospital	Fargo	North Dakota	United States	58122
359	MeritCare Medical Group	Fargo	North Dakota	United States	58122
360	McDowell Cancer Center at Akron General Medical Center	Akron	Ohio	United States	44307
361	Akron City Hospital	Akron	Ohio	United States	44309-2090
362	Wood County Oncology Center	Bowling Green	Ohio	United States	43402
363	Mercy Cancer Center at Mercy Medical Center	Canton	Ohio	United States	44708
364	Aultman Hospital Cancer Center at Aultman Health Foundation	Canton	Ohio	United States	44710-1799
365	Adena Regional Medical Center	Chillicothe	Ohio	United States	45601
366	Jewish Hospital Cancer Center	Cincinnati	Ohio	United States	45229
367	Charles M. Barrett Cancer Center at University Hospital	Cincinnati	Ohio	United States	45267
368	Case Comprehensive Cancer Center	Cleveland	Ohio	United States	44106
369	MetroHealth's Cancer Care Center at MetroHealth Medical Center	Cleveland	Ohio	United States	44109
370	Cleveland Clinic Taussig Cancer Center	Cleveland	Ohio	United States	44195
371	Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University	Columbus	Ohio	United States	43210-1240
372	Riverside Methodist Hospital Cancer Care	Columbus	Ohio	United States	43214-3998
373	CCOP - Columbus	Columbus	Ohio	United States	43215
374	Grant Riverside Cancer Services	Columbus	Ohio	United States	43215
375	Mount Carmel West Hospital	Columbus	Ohio	United States	43222
376	Doctors Hospital at Ohio Health	Columbus	Ohio	United States	43228
377	Grandview Hospital	Dayton	Ohio	United States	45405
378	Good Samaritan Hospital	Dayton	Ohio	United States	45406
379	David L. Rike Cancer Center at Miami Valley Hospital	Dayton	Ohio	United States	45409
380	Samaritan North Cancer Care Center	Dayton	Ohio	United States	45415
381	Veterans Affairs Medical Center - Dayton	Dayton	Ohio	United States	45428
382	CCOP - Dayton	Dayton	Ohio	United States	45429
383	Grady Memorial Hospital	Delaware	Ohio	United States	43015
384	Blanchard Valley Medical Associates	Findlay	Ohio	United States	45840
385	Fremont Memorial Hospital	Fremont	Ohio	United States	43420
386	Community Oncology Group at Cleveland Clinic Cancer Center	Independence	Ohio	United States	44131
387	Kenton Oncology, Incorporated	Kenton	Ohio	United States	43326
388	Charles F. Kettering Memorial Hospital	Kettering	Ohio	United States	45429
389	Fairfield Medical Center	Lancaster	Ohio	United States	43130
390	St. Rita's Medical Center	Lima	Ohio	United States	45801
391	Lima Memorial Hospital	Lima	Ohio	United States	45804
392	Strecker Cancer Center at Marietta Memorial Hospital	Marietta	Ohio	United States	45750
393	Northwest Ohio Oncology Center	Maumee	Ohio	United States	43537
394	St. Luke's Hospital	Maumee	Ohio	United States	43537
395	Middletown Regional Hospital	Middletown	Ohio	United States	45044
396	Licking Memorial Cancer Care Program at Licking Memorial Hospital	Newark	Ohio	United States	43055
397	St. Charles Mercy Hospital	Oregon	Ohio	United States	43616
398	Toledo Clinic - Oregon	Oregon	Ohio	United States	43616
399	Firelands Regional Medical Center	Sandusky	Ohio	United States	44870
400	North Coast Cancer Care, Incorporated	Sandusky	Ohio	United States	44870
401	Mercy Medical Center	Springfield	Ohio	United States	45504
402	Community Hospital of Springfield and Clark County	Springfield	Ohio	United States	45505
403	Promedica Cancer Center at Flower Hospital	Sylvania	Ohio	United States	43560
404	Mercy Hospital of Tiffin	Tiffin	Ohio	United States	44883
405	Toledo Hospital	Toledo	Ohio	United States	43606
406	St. Vincent Mercy Medical Center	Toledo	Ohio	United States	43608
407	Medical University of Ohio Cancer Center	Toledo	Ohio	United States	43614
408	CCOP - Toledo Community Hospital	Toledo	Ohio	United States	43623
409	Toledo Clinic, Incorporated - Main Clinic	Toledo	Ohio	United States	43623
410	Toledo Surgical Specialists	Toledo	Ohio	United States	43623
411	UVMC Cancer Care Center at Upper Valley Medical Center	Troy	Ohio	United States	45373-1300
412	Fulton County Health Center	Wauseon	Ohio	United States	43567
413	Mount Carmel Cancer Services at Mount Carmel St. Ann's Hospital	Westerville	Ohio	United States	43081
414	Cleveland Clinic - Wooster	Wooster	Ohio	United States	44691
415	Ruth G. McMillan Cancer Center at Greene Memorial Hospital	Xenia	Ohio	United States	45385
416	Genesis - Good Samaritan Hospital	Zanesville	Ohio	United States	43701
417	Comanche County Memorial Hospital	Lawton	Oklahoma	United States	73505
418	LaFortune Cancer Center at St. John Medical Center	Tulsa	Oklahoma	United States	74104
419	Natalie Warren Bryant Cancer Center at St. Francis Hospital	Tulsa	Oklahoma	United States	74136
420	Legacy Mount Hood Medical Center	Gresham	Oregon	United States	97030
421	Providence Milwaukie Hospital	Milwaukie	Oregon	United States	97222
422	Legacy Good Samaritan Hospital & Medical Center Comprehensive Cancer Center	Portland	Oregon	United States	97210
423	Providence Cancer Center at Providence Portland Medical Center	Portland	Oregon	United States	97213-2967
424	CCOP - Columbia River Oncology Program	Portland	Oregon	United States	97225
425	Providence St. Vincent Medical Center	Portland	Oregon	United States	97225
426	Legacy Emanuel Hospital and Health Center & Children's Hospital	Portland	Oregon	United States	97227
427	Kaiser Permanente Health Care - Portland	Portland	Oregon	United States	97232
428	Legacy Meridian Park Hospital	Tualatin	Oregon	United States	97062
429	Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest	Allentown	Pennsylvania	United States	18105
430	Bryn Mawr Hospital	Bryn Mawr	Pennsylvania	United States	19010
431	Delaware County Regional Cancer Center at Delaware County Memorial Hospital	Drexel Hill	Pennsylvania	United States	19026
432	Penn State Cancer Institute at Milton S. Hershey Medical Center	Hershey	Pennsylvania	United States	17033-0850
433	St. Mary Regional Cancer Center	Langhorne	Pennsylvania	United States	19047
434	Paoli Memorial Hospital	Paoli	Pennsylvania	United States	19301-1792
435	Abramson Cancer Center of the University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104-4283
436	Joan Karnell Cancer Center at Pennsylvania Hospital	Philadelphia	Pennsylvania	United States	19107
437	Fox Chase Cancer Center	Philadelphia	Pennsylvania	United States	19111-2497
438	Mercy Hospital Cancer Center - Scranton	Scranton	Pennsylvania	United States	18501
439	Hematology and Oncology Associates	Scranton	Pennsylvania	United States	18510
440	Chester County Hospital	West Chester	Pennsylvania	United States	19380
441	Jennersville Regional Hospital	West Grove	Pennsylvania	United States	19390-9499
442	CCOP - MainLine Health	Wynnewood	Pennsylvania	United States	19096
443	Lankenau Cancer Center at Lankenau Hospital	Wynnewood	Pennsylvania	United States	19096
444	Hollings Cancer Center at Medical University of South Carolina	Charleston	South Carolina	United States	29425
445	Bon Secours St. Francis Health System	Greenville	South Carolina	United States	29601
446	CCOP - Greenville	Greenville	South Carolina	United States	29615
447	Oncology Services of Aberdeen	Aberdeen	South Dakota	United States	57401
448	Avera Cancer Institute	Sioux Falls	South Dakota	United States	57105
449	Medical X-Ray Center, PC	Sioux Falls	South Dakota	United States	57105
450	Sioux Valley Hospital and University of South Dakota Medical Center	Sioux Falls	South Dakota	United States	57117-5039
451	Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center	Kingsport	Tennessee	United States	37662
452	Baptist Regional Cancer Center at Baptist Hospital of East Tennessee	Knoxville	Tennessee	United States	37901
453	Thompson Cancer Survival Center	Knoxville	Tennessee	United States	37916
454	Vanderbilt-Ingram Cancer Center	Nashville	Tennessee	United States	37232
455	Brooke Army Medical Center	Fort Sam Houston	Texas	United States	78234
456	Wilford Hall Medical Center	Lackland Air Force Base	Texas	United States	78236
457	Doctor's Hospital of Laredo	Laredo	Texas	United States	78041
458	UMC Southwest Cancer and Research Center	Lubbock	Texas	United States	79415-3364
459	Veterans Affairs Medical Center - San Antonio (Murphy)	San Antonio	Texas	United States	78209
460	University of Texas Health Science Center at San Antonio	San Antonio	Texas	United States	78229-3900
461	Cancer Therapy and Research Center	San Antonio	Texas	United States	78229
462	University Hospital - San Antonio	San Antonio	Texas	United States	78229
463	CCOP - Scott and White Hospital	Temple	Texas	United States	76508
464	American Fork Hospital	American Fork	Utah	United States	84003
465	Logan Regional Hospital	Logan	Utah	United States	84321
466	Cottonwood Hospital Medical Center	Murray	Utah	United States	84107
467	McKay-Dee Hospital Center	Ogden	Utah	United States	84403
468	Utah Valley Regional Medical Center - Provo	Provo	Utah	United States	84604
469	Dixie Regional Medical Center - East Campus	Saint George	Utah	United States	84770
470	Utah Cancer Specialists at UCS Cancer Center	Salt Lake City	Utah	United States	84106
471	Huntsman Cancer Institute at University of Utah	Salt Lake City	Utah	United States	84112
472	LDS Hospital	Salt Lake City	Utah	United States	84143
473	Green Mountain Oncology Group	Bennington	Vermont	United States	05201
474	Southwestern Vermont Regional Cancer Center	Bennington	Vermont	United States	05201
475	Mountainview Medical	Berlin Corners	Vermont	United States	05602
476	Fletcher Allen Health Care - University Health Center Campus	Burlington	Vermont	United States	05401
477	Mount Ascutney Hospital	Windsor	Vermont	United States	05089
478	Danville Regional Medical Center	Danville	Virginia	United States	24541
479	Virginia Oncology Associates - Hampton	Hampton	Virginia	United States	23666
480	Southwest Virginia Regional Cancer Center	Norton	Virginia	United States	24273
481	Massey Cancer Center at Virginia Commonwealth University	Richmond	Virginia	United States	23298-0037
482	St. Joseph Hospital Community Cancer Center	Bellingham	Washington	United States	98225
483	Olympic Hematology and Oncology	Bremerton	Washington	United States	98310
484	Skagit Valley Hospital Cancer Care Center	Mount Vernon	Washington	United States	98273
485	CCOP - Virginia Mason Research Center	Seattle	Washington	United States	98101
486	Fred Hutchinson Cancer Research Center	Seattle	Washington	United States	98104
487	Harborview Medical Center	Seattle	Washington	United States	98104
488	Minor and James Medical, PLLC	Seattle	Washington	United States	98104
489	Group Health Central Hospital	Seattle	Washington	United States	98112
490	Swedish Cancer Institute at Swedish Medical Center - First Hill Campus	Seattle	Washington	United States	98114
491	Polyclinic First Hill	Seattle	Washington	United States	98122
492	University Cancer Center at University of Washington Medical Center	Seattle	Washington	United States	98195-6043
493	North Puget Oncology at United General Hospital	Sedro-Woolley	Washington	United States	98284
494	Cancer Care Northwest - Spokane South	Spokane	Washington	United States	99202
495	Providence Cancer Center at Sacred Heart Medical Center	Spokane	Washington	United States	99204
496	Providence Cancer Center at Holy Family Hospital	Spokane	Washington	United States	99207
497	Madigan Army Medical Center - Tacoma	Tacoma	Washington	United States	98431
498	Southwest Washington Medical Center Cancer Center	Vancouver	Washington	United States	98668
499	Wenatchee Valley Clinic	Wenatchee	Washington	United States	98801
500	North Star Lodge Cancer Center at Yakima Valley Memorial Hospital	Yakima	Washington	United States	98902
501	Washington Hematology-Oncology Specialists	Yakima	Washington	United States	98902
502	West Virginia University - Robert C. Byrd Health Sciences Center - Charleston Division	Charleston	West Virginia	United States	25304
503	Mary Babb Randolph Cancer Center at West Virginia University Hospitals	Morgantown	West Virginia	United States	26506
504	Green Bay Oncology, Limited at St. Vincent Hospital	Green Bay	Wisconsin	United States	54301-3526
505	Green Bay Oncology, Limited at St. Mary's Hospital	Green Bay	Wisconsin	United States	54303
506	St. Mary's Hospital Medical Center - Green Bay	Green Bay	Wisconsin	United States	54303
507	St. Vincent Hospital Regional Cancer Center	Green Bay	Wisconsin	United States	54307-3508
508	Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center	La Crosse	Wisconsin	United States	54601
509	Dean Medical Center - Fish Hatchery	Madison	Wisconsin	United States	53715
510	University of Wisconsin Comprehensive Cancer Center	Madison	Wisconsin	United States	53792-6164
511	Holy Family Memorial Medical Center Cancer Care Center	Manitowoc	Wisconsin	United States	54221-1450
512	Bay Area Cancer Care Center at Bay Area Medical Center	Marinette	Wisconsin	United States	54143
513	Marshfield Clinic - Marshfield Center	Marshfield	Wisconsin	United States	54449
514	Medical College of Wisconsin Cancer Center	Milwaukee	Wisconsin	United States	53226
515	Green Bay Oncology, Limited - Oconto Falls	Oconto Falls	Wisconsin	United States	54154
516	Green Bay Oncology, Limited - Sturgeon Bay	Sturgeon Bay	Wisconsin	United States	54235
517	Welch Cancer Center at Sheridan Memorial Hospital	Sheridan	Wyoming	United States	82801
518	Tom Baker Cancer Centre - Calgary	Calgary	Alberta	Canada	T2N 4N2
519	Cross Cancer Institute at University of Alberta	Edmonton	Alberta	Canada	T6G 1Z2
520	British Columbia Cancer Agency - Vancouver Cancer Centre	Vancouver	British Columbia	Canada	V5Z 4E6
521	CancerCare Manitoba	Winnipeg	Manitoba	Canada	R3E 0V9
522	Saint John Regional Hospital	Saint John	New Brunswick	Canada	E2L 4L2
523	Nova Scotia Cancer Centre	Halifax	Nova Scotia	Canada	B3H 2Y9
524	Margaret and Charles Juravinski Cancer Centre	Hamilton	Ontario	Canada	L8V 5C2
525	McMaster Children's Hospital at Hamilton Health Sciences	Hamilton	Ontario	Canada	ON L8N 3Z5
526	London Regional Cancer Program at London Health Sciences Centre	London	Ontario	Canada	N6A 4L6
527	St. Catharines General Hospital at Niagara Health System	St. Catharines	Ontario	Canada	L2R 5K3
528	Northeastern Ontario Regional Cancer Centre	Sudbury	Ontario	Canada	P3E 5J1
529	Northwestern Ontario Regional Cancer Care at Thunder Bay Regional Health Sciences Centre	Thunder Bay	Ontario	Canada	P7B 6V4
530	Toronto Sunnybrook Regional Cancer Centre at Sunnybrook Health Sciences Centre	Toronto	Ontario	Canada	M4N 3M5
531	Princess Margaret Hospital	Toronto	Ontario	Canada	M5G 2M9
532	Hopital Charles Lemoyne	Greenfield Park	Quebec	Canada	J4V 2H1
533	Maisonneuve-Rosemont Hospital	Montreal	Quebec	Canada	H1T 2M4
534	Centre Hospitalier de l'Universite de Montreal	Montreal	Quebec	Canada	H2L 4MI
535	McGill Cancer Centre at McGill University	Montreal	Quebec	Canada	H3G 1A4
536	Centre Hospitalier Universitaire de Quebec	Quebec City	Quebec	Canada	G1R 2J6
537	Allan Blair Cancer Centre at Pasqua Hospital	Regina	Saskatchewan	Canada	S4T 7T1
538	Saskatoon Cancer Centre at the University of Saskatchewan	Saskatoon	Saskatchewan	Canada	S7N 4H4
539	Pretoria Academic Hospital	Pretoria, 0001		South Africa

Sponsors and Collaborators

• Eastern Cooperative Oncology Group
• National Cancer Institute (NCI)

Investigators

• Study Chair: Sandra J. Horning, MD, Stanford University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Eastern Cooperative Oncology Group
• ClinicalTrials.gov Identifier: NCT00003389
• Other Study ID Numbers: CDR0000066386; E2496; U10CA021115
• First Posted: Jan 27, 2003
• Last Update Posted: Nov 20, 2017
• Last Verified: Oct 1, 2017

• Keywords provided by Eastern Cooperative Oncology Group: stage I adult Hodgkin lymphoma; stage II adult Hodgkin lymphoma; stage III adult Hodgkin lymphoma; stage IV adult Hodgkin lymphoma; adult lymphocyte depletion Hodgkin lymphoma; adult nodular sclerosis Hodgkin lymphoma; adult mixed cellularity Hodgkin lymphoma
• Additional relevant MeSH terms: Lymphoma; Prednisone; Cyclophosphamide; Dacarbazine; Mechlorethamine; Doxorubicin; Liposomal doxorubicin; Etoposide; Vincristine; Etoposide phosphate; Bleomycin; Vinblastine; Podophyllotoxin; Imidazole

Study Results

Participant Flow

Recruitment Details	Between April 22, 1999 and June 15, 2006, 854 participants were enrolled.

Arm/Group Title	Arm A (ABVD)	Arm B (Stanford V)
Arm/Group Description	Arm A (ABVD): Patients receive doxorubicin (25 mg/m²), bleomycin (10 u/m²), vinblastine (6 mg/m²), and dacarbazine (375 mg/m²) intravenously (IV) on days 1 and 15. Courses repeat every 28 days. Patients are restaged after 4 courses. Patients who are in complete remission receive 2 additional courses. Patients with a partial response or less are evaluated after 6 courses, and if there is an ongoing response, patients may receive 2 additional courses for a total of 8. If no ongoing response is observed, patients are removed from the study. All patients with massive mediastinal disease, regardless of stage, receive radiotherapy 2-3 weeks after completion of chemotherapy. Doxorubicin: given IV Bleomycin: given IV Vinblastine: given IV Dacarbazine: given IV Radiotherapy	Arm B (Stanford V): Patients receive Stanford V chemotherapy comprising doxorubicin (25 mg/m²) and vinblastine (6 mg/m²) IV on day 1 of weeks 1, 3, 5, 7, 9, and 11; vincristine (1.4 mg/m²) and bleomycin (5 u/m²) IV on day 1 of weeks 2, 4, 6, 8, 10, and 12; mechlorethamine (6 mg/m²) IV on day 1 of weeks 1, 5, and 9 (if mechlorethamine is unavailable, may substitute with cyclophosphamide [375 mg/m²] IV); etoposide (60 mg/m²) IV on days 1 and 2 of weeks 3, 7, and 11; and oral prednisone (40 mg/m²) every other day of weeks 1-9 followed by a taper. All patients with bulky disease receive radiotherapy 2-3 weeks after completion of chemotherapy. Doxorubicin: given IV Bleomycin: given IV Vinblastine: given IV Vincristine: given IV Mechlorethamine: given IV Etoposide: given IV Prednisone: taken orally Cyclophosphamide: given IV Radiotherapy
Period Title: Overall Study
STARTED	428	426
Treated Pts w/ Toxicity Data Available	414	422
Eligible Patients	395	399
COMPLETED	330	366
NOT COMPLETED	98	60

Baseline Characteristics

Arm/Group Title	Arm A (ABVD)	Arm B (Stanford V)	Total
Arm/Group Description	Arm A (ABVD): Patients receive doxorubicin (25 mg/m²), bleomycin (10 u/m²), vinblastine (6 mg/m²), and dacarbazine (375 mg/m²) intravenously (IV) on days 1 and 15. Courses repeat every 28 days. Patients are restaged after 4 courses. Patients who are in complete remission receive 2 additional courses. Patients with a partial response or less are evaluated after 6 courses, and if there is an ongoing response, patients may receive 2 additional courses for a total of 8. If no ongoing response is observed, patients are removed from the study. All patients with massive mediastinal disease, regardless of stage, receive radiotherapy 2-3 weeks after completion of chemotherapy.	Arm B (Stanford V): Patients receive Stanford V chemotherapy comprising doxorubicin (25 mg/m²) and vinblastine (6 mg/m²) IV on day 1 of weeks 1, 3, 5, 7, 9, and 11; vincristine (1.4 mg/m²) and bleomycin (5 u/m²) IV on day 1 of weeks 2, 4, 6, 8, 10, and 12; mechlorethamine (6 mg/m²) IV on day 1 of weeks 1, 5, and 9 (if mechlorethamine is unavailable, may substitute with cyclophosphamide [375 mg/m²] IV); etoposide (60 mg/m²) IV on days 1 and 2 of weeks 3, 7, and 11; and oral prednisone (40 mg/m²) every other day of weeks 1-9 followed by a taper. All patients with bulky disease receive radiotherapy 2-3 weeks after completion of chemotherapy.	Total of all reporting groups
Overall Participants	395	399	794
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	33	33	33
Sex: Female, Male (Count of Participants)
Female	187 47.3%	182 45.6%	369 46.5%
Male	208 52.7%	217 54.4%	425 53.5%
Region of Enrollment (participants) [Number]
Canada	46 11.6%	50 12.5%	96 12.1%
United States	349 88.4%	349 87.5%	698 87.9%

Outcome Measures

1. Primary Outcome

Title	Failure-free Survival at 5 Years
Description	Failure-free survival is defined as the time from randomization to the earlier of progression/relapse or death. The 5-year failure-free survival is the probability a patient is failure-free and survives 5 years. Progression is defined as an increase in size of 25% of the sum of the products of the pretreatment measurements or appearance of new lesions. Significant enlargement of the liver or spleen is evidence of progression. A significant increase in size is defined as > 2.0 cm in distance between costal margin and the inferior margin of either organ. Relapse is defined as the re-appearance of any clinical evidence of Hodgkin's disease in a patient who has had a complete response. Relapse for partial responders is defined as progressive disease relative to disease status during the partial remission.
Time Frame	Assessed every 2 months if patient is < 1 year from study entry, every 3 months for the second year, every 4 months for the third year, every 6 months for years 4 and 5

Outcome Measure Data

Analysis Population Description

Eligible patients

Arm/Group Title	Arm A (ABVD)	Arm B (Stanford V)
Arm/Group Description	Arm A (ABVD): Patients receive doxorubicin (25 mg/m²), bleomycin (10 u/m²), vinblastine (6 mg/m²), and dacarbazine (375 mg/m²) intravenously (IV) on days 1 and 15. Courses repeat every 28 days. Patients are restaged after 4 courses. Patients who are in complete remission receive 2 additional courses. Patients with a partial response or less are evaluated after 6 courses, and if there is an ongoing response, patients may receive 2 additional courses for a total of 8. If no ongoing response is observed, patients are removed from the study. All patients with massive mediastinal disease, regardless of stage, receive radiotherapy 2-3 weeks after completion of chemotherapy.	Arm B (Stanford V): Patients receive Stanford V chemotherapy comprising doxorubicin (25 mg/m²) and vinblastine (6 mg/m²) IV on day 1 of weeks 1, 3, 5, 7, 9, and 11; vincristine (1.4 mg/m²) and bleomycin (5 u/m²) IV on day 1 of weeks 2, 4, 6, 8, 10, and 12; mechlorethamine (6 mg/m²) IV on day 1 of weeks 1, 5, and 9 (if mechlorethamine is unavailable, may substitute with cyclophosphamide [375 mg/m²] IV); etoposide (60 mg/m²) IV on days 1 and 2 of weeks 3, 7, and 11; and oral prednisone (40 mg/m²) every other day of weeks 1-9 followed by a taper. All patients with bulky disease receive radiotherapy 2-3 weeks after completion of chemotherapy.
Measure Participants	395	399
Number (95% Confidence Interval) [Proportion of patients]	0.74	0.71

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm A (ABVD), Arm B (Stanford V)
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.32
	Comments
	Method	Log Rank
	Comments	Stratified log rank test was performed.

2. Secondary Outcome

Title	5-year Overall Survival
Description	Overall survival is defined as the time from randomization to death or last known alive. The 5-year survival rate is the probability a patient survives 5 years.
Time Frame	Assessed every 2 months if patient is < 1 year from study entry, every 3 months for the second year, every 4 months for the third year, every 6 months for years 4 and 5, and yearly for 5 years

Outcome Measure Data

Analysis Population Description

Eligible patients

Arm/Group Title	Arm A (ABVD)	Arm B (Stanford V)
Arm/Group Description	Arm A (ABVD): Patients receive doxorubicin (25 mg/m²), bleomycin (10 u/m²), vinblastine (6 mg/m²), and dacarbazine (375 mg/m²) intravenously (IV) on days 1 and 15. Courses repeat every 28 days. Patients are restaged after 4 courses. Patients who are in complete remission receive 2 additional courses. Patients with a partial response or less are evaluated after 6 courses, and if there is an ongoing response, patients may receive 2 additional courses for a total of 8. If no ongoing response is observed, patients are removed from the study. All patients with massive mediastinal disease, regardless of stage, receive radiotherapy 2-3 weeks after completion of chemotherapy.	Arm B (Stanford V): Patients receive Stanford V chemotherapy comprising doxorubicin (25 mg/m²) and vinblastine (6 mg/m²) IV on day 1 of weeks 1, 3, 5, 7, 9, and 11; vincristine (1.4 mg/m²) and bleomycin (5 u/m²) IV on day 1 of weeks 2, 4, 6, 8, 10, and 12; mechlorethamine (6 mg/m²) IV on day 1 of weeks 1, 5, and 9 (if mechlorethamine is unavailable, may substitute with cyclophosphamide [375 mg/m²] IV); etoposide (60 mg/m²) IV on days 1 and 2 of weeks 3, 7, and 11; and oral prednisone (40 mg/m²) every other day of weeks 1-9 followed by a taper. All patients with bulky disease receive radiotherapy 2-3 weeks after completion of chemotherapy.
Measure Participants	395	399
Number (95% Confidence Interval) [Proportion of patients]	0.88	0.88

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm A (ABVD), Arm B (Stanford V)
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.86
	Comments
	Method	Log Rank
	Comments	Stratified log rank test was performed.

3. Secondary Outcome

Title	Incidence of Second Cancers
Description	Number of patients who developed second primary cancers
Time Frame	Assessed every 2 months if patient is < 1 year from study entry, every 3 months for the second year, every 4 months for the third year, every 6 months for years 4 and 5, and yearly for 5 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Arm A (ABVD)	Arm B (Stanford V)
Arm/Group Description	Arm A (ABVD): Patients receive doxorubicin (25 mg/m²), bleomycin (10 u/m²), vinblastine (6 mg/m²), and dacarbazine (375 mg/m²) intravenously (IV) on days 1 and 15. Courses repeat every 28 days. Patients are restaged after 4 courses. Patients who are in complete remission receive 2 additional courses. Patients with a partial response or less are evaluated after 6 courses, and if there is an ongoing response, patients may receive 2 additional courses for a total of 8. If no ongoing response is observed, patients are removed from the study. All patients with massive mediastinal disease, regardless of stage, receive radiotherapy 2-3 weeks after completion of chemotherapy.	Arm B (Stanford V): Patients receive Stanford V chemotherapy comprising doxorubicin (25 mg/m²) and vinblastine (6 mg/m²) IV on day 1 of weeks 1, 3, 5, 7, 9, and 11; vincristine (1.4 mg/m²) and bleomycin (5 u/m²) IV on day 1 of weeks 2, 4, 6, 8, 10, and 12; mechlorethamine (6 mg/m²) IV on day 1 of weeks 1, 5, and 9 (if mechlorethamine is unavailable, may substitute with cyclophosphamide [375 mg/m²] IV); etoposide (60 mg/m²) IV on days 1 and 2 of weeks 3, 7, and 11; and oral prednisone (40 mg/m²) every other day of weeks 1-9 followed by a taper. All patients with bulky disease receive radiotherapy 2-3 weeks after completion of chemotherapy.
Measure Participants	395	399
Number [participants]	15 3.8%	19 4.8%

Adverse Events

Time Frame	Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
Arm/Group Title	Arm A (ABVD)		Arm B (Stanford V)
Arm/Group Description	Patients receive doxorubicin (25 mg/m²), bleomycin (10 u/m²), vinblastine (6 mg/m²), and dacarbazine (375 mg/m²) intravenously (IV) on days 1 and 15. Courses repeat every 28 days. Patients are restaged after 4 courses. Patients who are in complete remission receive 2 additional courses. Patients with a partial response or less are evaluated after 6 courses, and if there is an ongoing response, patients may receive 2 additional courses for a total of 8. If no ongoing response is observed, patients are removed from the study. All patients with massive mediastinal disease, regardless of stage, receive radiotherapy 2-3 weeks after completion of chemotherapy.		Patients receive Stanford V chemotherapy comprising doxorubicin (25 mg/m²) and vinblastine (6 mg/m²) IV on day 1 of weeks 1, 3, 5, 7, 9, and 11; vincristine (1.4 mg/m²) and bleomycin (5 u/m²) IV on day 1 of weeks 2, 4, 6, 8, 10, and 12; mechlorethamine (6 mg/m²) IV on day 1 of weeks 1, 5, and 9 (if mechlorethamine is unavailable, may substitute with cyclophosphamide [375 mg/m²] IV); etoposide (60 mg/m²) IV on days 1 and 2 of weeks 3, 7, and 11; and oral prednisone (40 mg/m²) every other day of weeks 1-9 followed by a taper. All patients with bulky disease receive radiotherapy 2-3 weeks after completion of chemotherapy.
All Cause Mortality
	Arm A (ABVD)		Arm B (Stanford V)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Arm A (ABVD)		Arm B (Stanford V)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	355/414 (85.7%)		401/422 (95%)
Blood and lymphatic system disorders
Anemia	20/414 (4.8%)		86/422 (20.4%)
Transfusion: pRBCs	3/414 (0.7%)		16/422 (3.8%)
Febrile neutropenia	7/414 (1.7%)		11/422 (2.6%)
Cardiac disorders
Conduction abnormality	1/414 (0.2%)		0/422 (0%)
Sinus tachycardia	0/414 (0%)		3/422 (0.7%)
Supraventricular arrhythmias	0/414 (0%)		2/422 (0.5%)
Cardiac-ischemia	3/414 (0.7%)		2/422 (0.5%)
Cardiac-left ventricular function	2/414 (0.5%)		2/422 (0.5%)
Pericardial effusion/pericarditis	0/414 (0%)		1/422 (0.2%)
Cardiac-other	1/414 (0.2%)		1/422 (0.2%)
Ear and labyrinth disorders
Middle ear/hearing	0/414 (0%)		1/422 (0.2%)
Endocrine disorders
Hypothyroidism	3/414 (0.7%)		1/422 (0.2%)
Endocrine-other	1/414 (0.2%)		0/422 (0%)
Eye disorders
Blurred vision	0/414 (0%)		1/422 (0.2%)
Gastrointestinal disorders
Colitis	0/414 (0%)		1/422 (0.2%)
Constipation	13/414 (3.1%)		15/422 (3.6%)
Dyspepsia	1/414 (0.2%)		5/422 (1.2%)
Dysphagia	1/414 (0.2%)		5/422 (1.2%)
Dysphagia-esophageal radiation	0/414 (0%)		4/422 (0.9%)
Gastritis	0/414 (0%)		1/422 (0.2%)
Ileus	1/414 (0.2%)		2/422 (0.5%)
Mucositis due to radiation	0/414 (0%)		1/422 (0.2%)
Nausea	22/414 (5.3%)		17/422 (4%)
Pancreatitis	0/414 (0%)		1/422 (0.2%)
Stomatitis	2/414 (0.5%)		7/422 (1.7%)
Vomiting	16/414 (3.9%)		17/422 (4%)
Diarrhea w/o prior colostomy	1/414 (0.2%)		6/422 (1.4%)
Hematemesis	0/414 (0%)		1/422 (0.2%)
Melena/GI bleeding	0/414 (0%)		1/422 (0.2%)
Abdominal pain	3/414 (0.7%)		17/422 (4%)
General disorders
Fatigue	18/414 (4.3%)		15/422 (3.6%)
Fever	7/414 (1.7%)		8/422 (1.9%)
Injection site reaction	1/414 (0.2%)		1/422 (0.2%)
Chest pain	3/414 (0.7%)		3/422 (0.7%)
Dysmenorrhea	1/414 (0.2%)		0/422 (0%)
Pain due to radiation	0/414 (0%)		1/422 (0.2%)
Pain-other	2/414 (0.5%)		4/422 (0.9%)
Immune system disorders
Allergic reaction	0/414 (0%)		3/422 (0.7%)
Allergy-other	0/414 (0%)		1/422 (0.2%)
Infections and infestations
Catheter-related infection	0/414 (0%)		1/422 (0.2%)
Infection w/ grade 3 or 4 neutropenia	23/414 (5.6%)		27/422 (6.4%)
Infection w/ unknown ANC	1/414 (0.2%)		5/422 (1.2%)
Infection w/o neutropenia	13/414 (3.1%)		11/422 (2.6%)
Injury, poisoning and procedural complications
Radiation dermatitis	0/414 (0%)		2/422 (0.5%)
Investigations
Leukocytes decreased	138/414 (33.3%)		230/422 (54.5%)
Lymphopenia	175/414 (42.3%)		328/422 (77.7%)
Neutrophils decreased	313/414 (75.6%)		293/422 (69.4%)
Platelets decreased	10/414 (2.4%)		9/422 (2.1%)
Weight gain	1/414 (0.2%)		2/422 (0.5%)
Coagulation-other	0/414 (0%)		1/422 (0.2%)
Alkaline phosphatase increased	4/414 (1%)		5/422 (1.2%)
Blood bilirubin increased	9/414 (2.2%)		6/422 (1.4%)
Aspartate aminotransferase increased	4/414 (1%)		4/422 (0.9%)
Alanine aminotransferase increased	0/414 (0%)		1/422 (0.2%)
(DLCO) decreased	5/414 (1.2%)		0/422 (0%)
FEV1 decreased	0/414 (0%)		2/422 (0.5%)
Creatinine increased	5/414 (1.2%)		9/422 (2.1%)
Metabolism and nutrition disorders
Anorexia	0/414 (0%)		2/422 (0.5%)
Dehydration	3/414 (0.7%)		3/422 (0.7%)
Hypoalbuminemia	7/414 (1.7%)		7/422 (1.7%)
Hyperglycemia	11/414 (2.7%)		16/422 (3.8%)
Hypocalcemia	1/414 (0.2%)		0/422 (0%)
Hypoglycemia	5/414 (1.2%)		1/422 (0.2%)
Hypokalemia	1/414 (0.2%)		1/422 (0.2%)
Musculoskeletal and connective tissue disorders
Muscle weakness	0/414 (0%)		2/422 (0.5%)
Arthralgia	2/414 (0.5%)		7/422 (1.7%)
Bone pain	5/414 (1.2%)		11/422 (2.6%)
Myalgia	6/414 (1.4%)		10/422 (2.4%)
Nervous system disorders
Ataxia	1/414 (0.2%)		1/422 (0.2%)
Dizziness/lightheadedness	1/414 (0.2%)		1/422 (0.2%)
Extrapyramidal movement	0/414 (0%)		1/422 (0.2%)
Neuropathy-cranial	1/414 (0.2%)		0/422 (0%)
Neuropathy-motor	3/414 (0.7%)		24/422 (5.7%)
Neuropathy-sensory	11/414 (2.7%)		39/422 (9.2%)
Syncope	4/414 (1%)		5/422 (1.2%)
Vertigo	1/414 (0.2%)		1/422 (0.2%)
Headache	4/414 (1%)		3/422 (0.7%)
Neuropathic pain	3/414 (0.7%)		5/422 (1.2%)
Psychiatric disorders
Delusions	0/414 (0%)		1/422 (0.2%)
Insomnia	2/414 (0.5%)		5/422 (1.2%)
Anxiety/agitation	1/414 (0.2%)		2/422 (0.5%)
Depression	0/414 (0%)		1/422 (0.2%)
Renal and urinary disorders
Incontinence	1/414 (0.2%)		0/422 (0%)
Urinary frequency/urgency	0/414 (0%)		1/422 (0.2%)
Renal/GU-other	1/414 (0.2%)		0/422 (0%)
Reproductive system and breast disorders
Irregular menses	1/414 (0.2%)		11/422 (2.6%)
Male infertility	0/414 (0%)		1/422 (0.2%)
Respiratory, thoracic and mediastinal disorders
(ARDS)	0/414 (0%)		1/422 (0.2%)
Cough	4/414 (1%)		4/422 (0.9%)
Dyspnea	21/414 (5.1%)		14/422 (3.3%)
Hiccoughs	1/414 (0.2%)		0/422 (0%)
Hypoxia	4/414 (1%)		1/422 (0.2%)
Pneumonitis/pulmonary infiltrates	5/414 (1.2%)		4/422 (0.9%)
Pulmonary fibrosis	2/414 (0.5%)		0/422 (0%)
Voice changes/stridor	0/414 (0%)		2/422 (0.5%)
Pulmonary-other	1/414 (0.2%)		0/422 (0%)
Skin and subcutaneous tissue disorders
Hand-foot reaction	1/414 (0.2%)		1/422 (0.2%)
Pruritus	4/414 (1%)		1/422 (0.2%)
Rash/desquamation	3/414 (0.7%)		2/422 (0.5%)
Urticaria	0/414 (0%)		1/422 (0.2%)
Vascular disorders
Hypertension	1/414 (0.2%)		1/422 (0.2%)
Hypotension	0/414 (0%)		2/422 (0.5%)
Peripheral arterial ischemia	0/414 (0%)		2/422 (0.5%)
Thrombosis/embolism	11/414 (2.7%)		12/422 (2.8%)
Other (Not Including Serious) Adverse Events
	Arm A (ABVD)		Arm B (Stanford V)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	413/414 (99.8%)		422/422 (100%)
Blood and lymphatic system disorders
Anemia	374/414 (90.3%)		412/422 (97.6%)
Cardiac disorders
Edema	29/414 (7%)		29/422 (6.9%)
Gastrointestinal disorders
Constipation	195/414 (47.1%)		221/422 (52.4%)
Dyspepsia	68/414 (16.4%)		86/422 (20.4%)
Dysphagia	48/414 (11.6%)		82/422 (19.4%)
Dysphagia-esophageal radiation	15/414 (3.6%)		32/422 (7.6%)
Mouth dryness	8/414 (1.9%)		22/422 (5.2%)
Nausea	313/414 (75.6%)		283/422 (67.1%)
Stomatitis	138/414 (33.3%)		145/422 (34.4%)
Vomiting	191/414 (46.1%)		135/422 (32%)
Diarrhea w/o prior colostomy	75/414 (18.1%)		56/422 (13.3%)
Abdominal pain	50/414 (12.1%)		63/422 (14.9%)
General disorders
Fatigue	320/414 (77.3%)		311/422 (73.7%)
Fever	62/414 (15%)		57/422 (13.5%)
Rigors/chills	28/414 (6.8%)		39/422 (9.2%)
Injection site reaction	52/414 (12.6%)		37/422 (8.8%)
Chest pain	34/414 (8.2%)		35/422 (8.3%)
Pain-other	32/414 (7.7%)		35/422 (8.3%)
Infections and infestations
Infection w/o neutropenia	83/414 (20%)		57/422 (13.5%)
Injury, poisoning and procedural complications
Radiation dermatitis	18/414 (4.3%)		44/422 (10.4%)
Investigations
Leukocytes decreased	378/414 (91.3%)		394/422 (93.4%)
Lymphopenia	319/414 (77.1%)		379/422 (89.8%)
Neutrophils decreased	341/414 (82.4%)		354/422 (83.9%)
Platelets decreased	118/414 (28.5%)		116/422 (27.5%)
Weight gain	34/414 (8.2%)		47/422 (11.1%)
Weight loss	21/414 (5.1%)		25/422 (5.9%)
Alkaline phosphatase increased	156/414 (37.7%)		108/422 (25.6%)
Blood bilirubin increased	25/414 (6%)		35/422 (8.3%)
Aspartate aminotransferase increased	115/414 (27.8%)		111/422 (26.3%)
Creatinine increased	26/414 (6.3%)		31/422 (7.3%)
Metabolism and nutrition disorders
Anorexia	83/414 (20%)		66/422 (15.6%)
Hypoalbuminemia	187/414 (45.2%)		194/422 (46%)
Hyperglycemia	192/414 (46.4%)		255/422 (60.4%)
Hypoglycemia	51/414 (12.3%)		35/422 (8.3%)
Musculoskeletal and connective tissue disorders
Muscle weakness	10/414 (2.4%)		22/422 (5.2%)
Arthralgia	45/414 (10.9%)		69/422 (16.4%)
Bone pain	78/414 (18.8%)		50/422 (11.8%)
Myalgia	134/414 (32.4%)		168/422 (39.8%)
Nervous system disorders
Taste disturbance	54/414 (13%)		47/422 (11.1%)
Dizziness/lightheadedness	32/414 (7.7%)		39/422 (9.2%)
Neuropathy-motor	33/414 (8%)		65/422 (15.4%)
Neuropathy-sensory	196/414 (47.3%)		329/422 (78%)
Headache	72/414 (17.4%)		79/422 (18.7%)
Psychiatric disorders
Insomnia	67/414 (16.2%)		140/422 (33.2%)
Anxiety/agitation	32/414 (7.7%)		46/422 (10.9%)
Depression	34/414 (8.2%)		23/422 (5.5%)
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis	24/414 (5.8%)		9/422 (2.1%)
Cough	117/414 (28.3%)		59/422 (14%)
Dyspnea	110/414 (26.6%)		95/422 (22.5%)
Pneumonitis/pulmonary infiltrates	30/414 (7.2%)		15/422 (3.6%)
Skin and subcutaneous tissue disorders
Sweating	41/414 (9.9%)		42/422 (10%)
Alopecia	287/414 (69.3%)		318/422 (75.4%)
Nail changes	31/414 (7.5%)		14/422 (3.3%)
Pruritus	26/414 (6.3%)		31/422 (7.3%)
Rash/desquamation	46/414 (11.1%)		53/422 (12.6%)
Vascular disorders
Phlebitis	25/414 (6%)		35/422 (8.3%)
Hot flashes	30/414 (7.2%)		24/422 (5.7%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT 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.