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A Randomized Phase III Trial of ABVD Versus Stanford V(+/-) Radiation Therapy in Locally Extensive and Advanced Stage Hodgkin's Disease Without High Risk Features

Phase 3
16 Years
Open (Enrolling)

Thank you

Trial Information

A Randomized Phase III Trial of ABVD Versus Stanford V(+/-) Radiation Therapy in Locally Extensive and Advanced Stage Hodgkin's Disease Without High Risk Features


- 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

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

- Arm I: Patients receive doxorubicin, bleomycin, vinblastine, and dacarbazine 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

- Arm II: Patients receive Stanford V chemotherapy comprising doxorubicin and vinblastine
IV on day 1 of weeks 1, 3, 5, 7, 9, and 11; vincristine and bleomycin IV on day 1 of
weeks 2, 4, 6, 8, 10, and 12; mechlorethamine IV on day 1 of weeks 1, 5, and 9 (if
mechlorethamine is unavailable, may substitute with cyclophosphamide IV); etoposide IV
on days 1 and 2 of weeks 3, 7, and 11; and oral prednisone 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.

Inclusion Criteria


- Histologically proven previously untreated classical Hodgkin's lymphoma of the
following subtypes:

- Nodular sclerosis

- Mixed cellularity

- Lymphocyte depletion

- Lymphocyte rich

- The following stages are eligible:

- Stage I-IIA/B with massive mediastinal adenopathy

- Stage III or IV

- Measurable or evaluable disease



- 16 and over

Performance status:

- ECOG 0-2

Life expectancy:

- Not specified


- WBC at least 4,000/mm^3 (unless documented bone marrow involvement)

- Platelet count at least 100,000/mm^3 (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


- Not pregnant or nursing

- Fertile patients must use effective contraception

- HIV negative

- No other malignancy within the past 5 years except curatively treated basal cell or
squamous cell skin cancer or carcinoma in situ of the cervix


Biologic therapy:

- Not specified


- No prior chemotherapy

Endocrine therapy:

- Prior corticosteroids allowed


- No prior radiotherapy


- Prior surgery allowed

Type of Study:


Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Outcome Measure:

Failure-free survival as measured by two-sided 0.05 level logrank test at completion of therapy and then every 6 months for 3 years

Safety Issue:


Principal Investigator

Sandra J. Horning, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Stanford University


United States: Federal Government

Study ID:




Start Date:

November 2000

Completion Date:

Related Keywords:

  • Lymphoma
  • 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
  • Hodgkin Disease
  • Lymphoma



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M.D. Anderson Cancer Center - Orlando Orlando, Florida  32806
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Memorial Hospital Carthage, Illinois  62321
Swedish Covenant Hospital Chicago, Illinois  60625
Mercy Hospital and Medical Center Chicago, Illinois  60616
Hematology and Oncology Associates Chicago, Illinois  60611
Eureka Community Hospital Eureka, Illinois  61530
Galesburg Cottage Hospital Galesburg, Illinois  61401
Galesburg Clinic Galesburg, Illinois  61401
InterCommunity Cancer Center of Western Illinois Galesburg, Illinois  61401
Ingalls Cancer Care Center at Ingalls Memorial Hospital Harvey, Illinois  60426
Mason District Hospital Havana, Illinois  62644
Hopedale Medical Complex Hopedale, Illinois  61747
Midwest Center for Hematology/Oncology Joliet, Illinois  60432
Kewanee Hospital Kewanee, Illinois  61443
North Shore Oncology and Hematology Associates, Limited - Libertyville Libertyville, Illinois  60048
McDonough District Hospital Macomb, Illinois  61455
Trinity Medical Center - East Moline, Illinois  61265
Edward Hospital Cancer Center Naperville, Illinois  60540
Hematology Oncology Consultants - Naperville Naperville, Illinois  60540
Northwest Medical Specialist, PC Niles, Illinois  60714
BroMenn Regional Medical Center Normal, Illinois  61761
Community Cancer Center Normal, Illinois  61761
Community Hospital of Ottawa Ottawa, Illinois  61350
Oncology Hematology Associates of Central Illinois, PC - Ottawa Ottawa, Illinois  61350
Cancer Treatment Center at Pekin Hospital Pekin, Illinois  61554
Oncology Hematology Associates of Central Illinois, PC - Peoria Peoria, Illinois  61615
OSF St. Francis Medical Center Peoria, Illinois  61637
Proctor Hospital Peoria, Illinois  61614
Illinois Valley Community Hospital Peru, Illinois  61354
Perry Memorial Hospital Princeton, Illinois  61356
Midwest Cancer Research Group, Incorporated Skokie, Illinois  60077
Hematology/Oncology of the North Shore at Gross Point Medical Center Skokie, Illinois  60076
St. Margaret's Hospital Spring Valley, Illinois  61362
Valley Cancer Center Spring Valley, Illinois  61362
St. Francis Hospital and Health Centers - Beech Grove Campus Beech Grove, Indiana  46107
Fort Wayne Medical Oncology and Hematology Fort Wayne, Indiana  46815
Howard Community Hospital at Howard Regional Health System Kokomo, Indiana  46904
Center for Cancer Therapy at LaPorte Hospital and Health Services La Porte, Indiana  46350
Medical Consultants, P. C. at Ball Cancer Center Muncie, Indiana  47303
Reid Hospital & Health Care Services, Incorporated Richmond, Indiana  47374
McFarland Clinic, P. C. Ames, Iowa  50010
Bettendorf, Iowa  52722
St. Luke's Hospital Cedar Rapids, Iowa  52402
Mercy Regional Cancer Center at Mercy Medical Center Cedar Rapids, Iowa  52403
Genesis Medical Center - West Campus Davenport, Iowa  52804
Genesis Regional Cancer Center at Genesis Medical Center Davenport, Iowa  52803
John Stoddard Cancer Center at Iowa Lutheran Hospital Des Moines, Iowa  50316-2301
Mercy Capitol Hospital Des Moines, Iowa  50307
Medical Oncology and Hematology Associates at John Stoddard Cancer Center Des Moines, Iowa  50309
Medical Oncology and Hematology Associates at Mercy Cancer Center Des Moines, Iowa  50314
Mercy Cancer Center at Mercy Medical Center - Des Moines Des Moines, Iowa  50314
Burgess Health Center Onawa, Iowa  51040
Medical Oncology and Hematology Associates - West Des Moines West Des Moines, Iowa  50266
Cancer Center of Kansas, P.A. - Chanute Chanute, Kansas  66720
Cancer Center of Kansas, PA - Dodge City Dodge City, Kansas  67801
Cancer Center of Kansas, P.A. - Kingman Kingman, Kansas  67068
Cancer Center of Kansas, P.A. - Newton Newton, Kansas  67114
Cancer Center of Kansas, P.A. - Pratt Pratt, Kansas  67124
Cancer Center of Kansas, P.A. - Salina Salina, Kansas  67042
Salina Regional Health Center Salina, Kansas  67401
Stormont-Vail Cancer Center Topeka, Kansas  66604
St. Francis Comprehensive Cancer Center Topeka, Kansas  66606
Cancer Center of Kansas, P.A. - Wellington Wellington, Kansas  67152
Cancer Center of Kansas, P.A. - Medical Arts Tower Wichita, Kansas  67208
Associates in Womens Health, P.A. - North Review Wichita, Kansas  67203
Cancer Center of Kansas, P.A. - Winfield Winfield, Kansas  67156
Ochsner Clinic of Baton Rouge Baton Rouge, Louisiana  708169990
Pennington Cancer Center at Baton Rouge General Baton Rouge, Louisiana  70806
Mary Bird Perkins Cancer Center - Baton Rouge Baton Rouge, Louisiana  70809
Terrebonne General Medical Center Houma, Louisiana  70360
Louisiana State University Health Sciences Center - Monroe Monroe, Louisiana  71210
Medical Center of Louisiana - New Orleans New Orleans, Louisiana  70112
Feist-Weiller Cancer Center at Louisiana State University Health Sciences Shreveport, Louisiana  71130-3932
Union Hospital Cancer Center at Union Hospital Elkton MD, Maryland  21921
Sturdy Memorial Hospital Attleboro, Massachusetts  02703
Franklin Medical Center Greenfield, Massachusetts  01301
Hickman Cancer Center at Bixby Medical Center Adrian, Michigan  49221
St. Joseph Mercy Cancer Center at St. Joseph Mercy Hospital Ann Arbor, Michigan  48106-0995
Bay Regional Medical Center Bay City, Michigan  48708
Mecosta County Medical Center Big Rapids, Michigan  49307
Green Bay Oncology, Limited - Iron Mountain Iron Mountain, Michigan  49801
Haematology-Oncology Associates of Ohio and Michigan, P.C. Lambertville, Michigan  48144
Upper Michigan Cancer Center at Marquette General Hospital Marquette, Michigan  49855
Community Cancer Center of Monroe Monroe, Michigan  48162
Mercy Memorial Hospital System Monroe, Michigan  48162
Providence Cancer Institute at Providence Hospital - Southfield Campus Southfield, Michigan  48075
Alexandria, Minnesota  56308
MeritCare Clinic - Bemidji Bemidji, Minnesota  56601
Brainerd Medical Center Brainerd, Minnesota  56401
St. Joseph's Medical Center Brainerd, Minnesota  56401
Virginia Piper Cancer Institute at Abbott-Northwestern Hospital Minneapolis, Minnesota  55407
Chippewa County - Montevideo Hospital Montevideo, Minnesota  56265
Hubert H. Humphrey Cancer Center at North Memorial Medical Center Robbinsdale, Minnesota  55422-2900
Coborn Cancer Center Saint Cloud, Minnesota  56303
CentraCare Clinic - River Campus St. Cloud, Minnesota  56303
Park Nicollet Health Services St. Louis Park, Minnesota  55416
Hattiesburg Clinic, P.A. Hattiesburg, Mississippi  39401
Saint Francis Medical Center Cape Girardeau, Missouri  63701
Saint Francis Cancer Treatment Center at Saint Francis Memorial Health Center Grand Island, Nebraska  68803
Bryan LGH Medical Center West Lincoln, Nebraska  68502
St. Elizabeth Regional Medical Center Lincoln, Nebraska  68510
Great Plains Regional Medical Center North Platte, Nebraska  69101-6598
Immanuel Medical Center Omaha, Nebraska  68122
Creighton University Medical Center Omaha, Nebraska  68131-2197
Kingsbury Center for Cancer Care at Cheshire Medical Center Keene, New Hampshire  03431
Frisbie Memorial Hospital Rochester, New Hampshire  03867
Mountainside Hospital Cancer Center Montclair, New Jersey  07042
Booker Cancer Center at Riverview Medical Center Red Bank, New Jersey  07701
Fox Chase Cancer Center at St. Francis Medical Center Trenton, New Jersey  08629
Cancer Institute of New Jersey at Cooper - Voorhees Voorhees, New Jersey  08043
Adirondack Cancer Care - Glens Falls Glens Falls, New York  12801
Charles R. Wood Cancer Center at Glens Falls Hospital Glens Falls, New York  12801
Oswego Hospital Oswego, New York  13126
Highland Hospital of Rochester Rochester, New York  14620
Community General Hospital of Greater Syracuse Syracuse, New York  13215
Wayne Radiation Oncology Goldsboro, North Carolina  27534
Iredell Memorial Hospital Statesville, North Carolina  28677
Wilson Medical Center Wilson, North Carolina  27893-3428
Forsyth Regional Cancer Center at Forsyth Medical Center Winston-Salem, North Carolina  27103
Cancer Care Center at Medcenter One Hospital Bismarck, North Dakota  58501
Bismarck Cancer Center Bismarck, North Dakota  58501
St. Alexius Medical Center Bismarck, North Dakota  58502
Mid Dakota Clinic, P. C. Bismarck, North Dakota  58501
MeritCare Medical Group Fargo, North Dakota  58122
Wood County Oncology Center Bowling Green, Ohio  43402
Samaritan North Cancer Care Center Dayton, Ohio  45415
Grandview Hospital Dayton, Ohio  45405
David L. Rike Cancer Center at Miami Valley Hospital Dayton, Ohio  45409
Good Samaritan Hospital Dayton, Ohio  45406
Blanchard Valley Medical Associates Findlay, Ohio  45840
Fremont Memorial Hospital Fremont, Ohio  43420
Community Oncology Group at Cleveland Clinic Cancer Center Independence, Ohio  44131
Kenton Oncology, Incorporated Kenton, Ohio  43326
Charles F. Kettering Memorial Hospital Kettering, Ohio  45429
Lima Memorial Hospital Lima, Ohio  45804
St. Luke's Hospital Maumee, Ohio  43537
Northwest Ohio Oncology Center Maumee, Ohio  43537
Middletown Regional Hospital Middletown, Ohio  45044
Toledo Clinic - Oregon Oregon, Ohio  43616
St. Charles Mercy Hospital Oregon, Ohio  43616
North Coast Cancer Care, Incorporated Sandusky, Ohio  44870
Firelands Regional Medical Center Sandusky, Ohio  44870
Mercy Medical Center Springfield, Ohio  45504
Promedica Cancer Center at Flower Hospital Sylvania, Ohio  43560
Mercy Hospital of Tiffin Tiffin, Ohio  44883
Toledo Clinic, Incorporated - Main Clinic Toledo, Ohio  43623
Toledo Surgical Specialists Toledo, Ohio  43623
UVMC Cancer Care Center at Upper Valley Medical Center Troy, Ohio  45373-1300
Fulton County Health Center Wauseon, Ohio  43567
Cleveland Clinic - Wooster Wooster, Ohio  44691
Ruth G. McMillan Cancer Center at Greene Memorial Hospital Xenia, Ohio  45385
Comanche County Memorial Hospital Lawton, Oklahoma  73505
LaFortune Cancer Center at St. John Medical Center Tulsa, Oklahoma  74104
Legacy Mount Hood Medical Center Gresham, Oregon  97030
Providence Milwaukie Hospital Milwaukie, Oregon  97222
Legacy Good Samaritan Hospital & Medical Center Comprehensive Cancer Center Portland, Oregon  97210
Kaiser Permanente Health Care - Portland Portland, Oregon  97232
Providence Cancer Center at Providence Portland Medical Center Portland, Oregon  97213-2967
Providence St. Vincent Medical Center Portland, Oregon  97225
Legacy Meridian Park Hospital Tualatin, Oregon  97062
Bryn Mawr Hospital Bryn Mawr, Pennsylvania  19010
Delaware County Regional Cancer Center at Delaware County Memorial Hospital Drexel Hill, Pennsylvania  19026
St. Mary Regional Cancer Center Langhorne, Pennsylvania  19047
Hematology and Oncology Associates Scranton, Pennsylvania  18510
Lankenau Cancer Center at Lankenau Hospital Wynnewood, Pennsylvania  19096
Bon Secours St. Francis Health System Greenville, South Carolina  29601
Oncology Services of Aberdeen Aberdeen, South Dakota  57401
Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center Kingsport, Tennessee  37662
Baptist Regional Cancer Center at Baptist Hospital of East Tennessee Knoxville, Tennessee  37901
Doctor's Hospital of Laredo Laredo, Texas  78041
UMC Southwest Cancer and Research Center Lubbock, Texas  79415-3364
Cancer Therapy and Research Center San Antonio, Texas  78229
University Hospital - San Antonio San Antonio, Texas  78229
Dixie Regional Medical Center - East Campus Saint George, Utah  84770
Southwestern Vermont Regional Cancer Center Bennington, Vermont  05201
Mountainview Medical Berlin, Vermont  05602
Mount Ascutney Hospital Windsor, Vermont  05089
Danville Regional Medical Center Danville, Virginia  24541
Virginia Oncology Associates - Hampton Hampton, Virginia  23666
Southwest Virginia Regional Cancer Center Norton, Virginia  24273
Minor and James Medical, PLLC Seattle, Washington  98104
Polyclinic First Hill Seattle, Washington  98122
Providence Cancer Center at Holy Family Hospital Spokane, Washington  99207
Southwest Washington Medical Center Cancer Center Vancouver, Washington  98668
North Star Lodge Cancer Center at Yakima Valley Memorial Hospital Yakima, Washington  98902
Washington Hematology-Oncology Specialists Yakima, Washington  98902
Green Bay Oncology, Limited at St. Vincent Hospital Green Bay, Wisconsin  54301-3526
Dean Medical Center - Fish Hatchery Madison, Wisconsin  53715
Holy Family Memorial Medical Center Cancer Care Center Manitowoc, Wisconsin  54221-1450
Welch Cancer Center at Sheridan Memorial Hospital Sheridan, Wyoming  82801