RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy with chemotherapy may kill more tumor cells.

PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with or without doxorubicin and vinblastine in treating patients with stage I or stage II Hodgkin's disease.

Condition	Treatment or Intervention
stage II adult Hodgkin's disease stage I adult Hodgkin's disease	Drug: doxorubicin  Drug: vinblastine

Further Study Details: 

OBJECTIVES: I. Compare progression-free and overall survival of patients with clinical Stage IA/IIA Hodgkin's disease who have not undergone laparotomy and who are randomized to treatment with subtotal nodal irradiation with vs. without 3 courses of doxorubicin/vinblastine.

II. Compare the long-term toxicities associated with these treatments, including cardiopulmonary toxicity, secondary malignancies, and infertility.

III. Identify subgroups of patients (based on age, gender, tumor histology, number of disease sites, and presence of high neck presentation) that are particularly responsive to these treatments.

PROTOCOL OUTLINE: Randomized study.

Arm I: Radiotherapy. Subtotal nodal irradiation using megavoltage equipment (4-10 MeV).

Arm II: 2-Drug Combination Chemotherapy followed by Radiotherapy. Doxorubicin, DOX, NSC-123127; Vinblastine, VBL, NSC-49842; followed by subtotal nodal irradiation as in Arm I.

PROJECTED ACCRUAL: 210 patients/arm will be enrolled over about 7 years.

Ages Eligible for Study:  16 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Biopsy-proven Hodgkin's disease, subclassified according to the Rye system; Clinical Stages IA, IEA, IIA, and IIEA according to modified Ann Arbor system; Staging laparotomy not allowed
• Completely resected disease allowed
• Residual disease, if present, must be bidimensionally measurable
• No mediastinal mass greater than 1/3 the maximum chest diameter
• No infradiaphragmatic presentation
• No pericardial E lesions (small pericardial effusions in the absence of nodular pericardial disease allowed)
• Concurrent registration on protocol SWOG-9208 (quality-of-life study) required unless patient does not understand or read English

--Prior/Concurrent Therapy--

• Biologic therapy: No prior biologic therapy
• Chemotherapy: No prior chemotherapy for any reason
• Endocrine therapy: Not specified
• Radiotherapy: No prior radiotherapy for any reason
• Surgery: No staging laparotomy

--Patient Characteristics--

• Age: 16 and over
• Performance status: SWOG 0-2
• Hematopoietic: AGC at least 2,000; Platelets within normal limits
• Hepatic: Bilirubin within normal limits
• Renal: Creatinine within normal limits
• Cardiovascular: LVEF normal; No serious EKG abnormality
• Pulmonary: No serious pulmonary condition
• Other: No serious medical condition other than Hodgkin's disease; No known AIDS or HIV-associated complex; No second malignancy within 5 years except: Adequately treated nonmelanomatous skin cancer, Adequately treated in situ carcinoma of the cervix; No pregnant or lactating women; Adequate contraception required of fertile patients
• Blood/body fluid analyses to determine eligibility completed within 14 days prior to registration; imaging studies for tumor measurement completed withi 28 days prior to registration; screening exams other than blood/body fluid analyses, and imaging studies of nonmeasurable disease or uninvolved organs completed within 42 days prior to registration

California
      University of California San Diego Cancer Center, La Jolla,  California,  92093-0658,  United States
Delaware
      CCOP - Christiana Care Health Services, Wilmington,  Delaware,  19899,  United States
District of Columbia
      Walter Reed Army Medical Center, Washington,  District of Columbia,  20307-5000,  United States
Florida
      CCOP - Mount Sinai Medical Center, Miami Beach,  Florida,  33140,  United States
Illinois
      University of Chicago Cancer Research Center, Chicago,  Illinois,  60637,  United States
Iowa
      University of Iowa Hospitals and Clinics, Iowa City,  Iowa,  52242,  United States
Massachusetts
      University of Massachusetts Memorial Medical Center, Worcester,  Massachusetts,  01655,  United States
Minnesota
      University of Minnesota Cancer Center, Minneapolis,  Minnesota,  55455,  United States
Missouri
      Barnes-Jewish Hospital, Saint Louis,  Missouri,  63110,  United States
      Ellis Fischel Cancer Center - Columbia, Columbia,  Missouri,  65203,  United States
Nevada
      CCOP - Southern Nevada Cancer Research Foundation, Las Vegas,  Nevada,  89106,  United States
New Hampshire
      Norris Cotton Cancer Center, Lebanon,  New Hampshire,  03756,  United States
New York
      CCOP - North Shore University Hospital, Manhasset,  New York,  11030,  United States
      Mount Sinai Medical Center, NY, New York,  New York,  10029,  United States
      Roswell Park Cancer Institute, Buffalo,  New York,  14263-0001,  United States
      State University of New York - Upstate Medical University, Syracuse,  New York,  13210,  United States
North Carolina
      CCOP - Southeast Cancer Control Consortium, Winston Salem,  North Carolina,  27104-4241,  United States
      Comprehensive Cancer Center of Wake Forest University Baptist Medical Center, Winston Salem,  North Carolina,  27157-1082,  United States
Rhode Island
      Rhode Island Hospital, Providence,  Rhode Island,  02903,  United States
Tennessee
      University of Tennessee, Memphis Cancer Center, Memphis,  Tennessee,  38163,  United States
Vermont
      Vermont Cancer Center, Burlington,  Vermont,  05401-3498,  United States
Virginia
      MBCCOP - Massey Cancer Center, Richmond,  Virginia,  23298-0037,  United States

Study chairs or principal investigators

Charles A. Coltman, Jr.,  Study Chair,  Southwest Oncology Group   
Todd H. Wasserman,  Study Chair

Study ID Numbers:  CDR0000077691; SWOG-9133
Record last reviewed:  July 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00002495
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08