Radiation Therapy and Chemotherapy in Treating Patients With Hodgkin's Disease
- Conditions
- Hodgkin Lymphoma
- Interventions
- Biological: bleomycin sulfateRadiation: radiation therapy
- Registration Number
- NCT00002561
- Lead Sponsor
- NCIC Clinical Trials Group
- Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high energy x-rays to damage tumor cells. Combining more than one drug or combining chemotherapy with radiation therapy may kill more tumor cells.
PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy, with or without chemotherapy, with chemotherapy alone in treating patients with stage I or stage IIA Hodgkin's disease.
- Detailed Description
OBJECTIVES: I. Compare the 12-year survival of patients with clinical stage I-IIA Hodgkin's disease treated with radiotherapy with or without doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD) versus ABVD only. II. Compare the freedom from progression at 5 and 10 years in patients treated with these regimens. III. Compare the complete remission rate, freedom from secondary disease progression at 5 and 10 years, and cause-specific survival at 5, 10, and 15 years in patients treated with these regimens. IV. Compare the short- and long-term toxicity of these regimens in these patients. V. Compare the quality of life of patients in patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified by center. Patients who are under age 40 and have lymphocyte-predominant or nodular sclerosing histology, an erythrocyte sedimentation rate less than 50, and fewer than 4 disease sites (supradiaphragmatic or pelvic node sites) are assigned to cohort 1 (good prognosis). All other patients are assigned to cohort 2 (poor prognosis). Cohort 1: Arm I: Patients with supradiaphragmatic disease undergo radiotherapy to the supradiaphragmatic lymph node areas (mantle region), spleen, and para-aortic lymph nodes 5 days a week for 4 weeks. Patients with pelvic disease undergo radiotherapy to an "inverted-Y" field (excluding the spleen) 5 days a week for 4 weeks. Arm II: Patients receive doxorubicin, bleomycin, vinblastine, and dacarbazine IV on days 1 and 15 (ABVD). Treatment continues every 4 weeks for a total of 2 courses in the absence of disease progression or unacceptable toxicity. Patients with complete remission (CR) after course 2 receive 2 additional courses past CR. Patients with partial remission (PR) after course 2 receive 4 additional courses past PR. Patients with unconfirmed/uncertain complete remission (CRu) receive 2-4 additional courses past CRu. Cohort 2: Arm III: Patients receive ABVD as in arm II, followed 4-6 weeks later by concurrent radiotherapy to the mantle region and upper abdomen to the level of L2 5 days a week for 4 weeks. Alternatively, radiotherapy may also be administered sequentially to the mantle region 5 days a week for 4 weeks and then to the upper abdomen to the level of L2 5 days a week for 4 weeks. Arm IV: Patients receive ABVD only as in arm II. Patients with disease progression after treatment in arms II or IV are considered for radiotherapy. Quality of life is assessed on day 1 of each course of chemotherapy (arms II-IV) and on day 28 of the last course of chemotherapy (arms II and IV); on the first and final days of radiotherapy (arms I and III); at 4 weeks and at 3, 6, and 12 months after completion of radiotherapy (arms I and III) or chemotherapy (arms II and IV); and then annually for 2-10 years. Patients are followed at months 3, 6, and 12 and then annually thereafter.
PROJECTED ACCRUAL: A total of 450 patients will be accrued for this study within 7.5 years.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 405
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description ABVD Alone bleomycin sulfate ABVD Alone Radiotherapy or ABVD + Radiotherapy radiation therapy Radiotherapy Radiotherapy or ABVD + Radiotherapy bleomycin sulfate Radiotherapy ABVD Alone dacarbazine ABVD Alone Radiotherapy or ABVD + Radiotherapy dacarbazine Radiotherapy Radiotherapy or ABVD + Radiotherapy doxorubicin hydrochloride Radiotherapy Radiotherapy or ABVD + Radiotherapy vinblastine Radiotherapy ABVD Alone doxorubicin hydrochloride ABVD Alone ABVD Alone vinblastine ABVD Alone
- Primary Outcome Measures
Name Time Method Survival 12 years 12 year survival comparison
- Secondary Outcome Measures
Name Time Method Freedom from progression 12 years Complete response rate 12 years Second disease progression rate 5 and 10 years Cause-specific survival rate 5 and 10 years treatment-related toxicity and Quality of Life.
Trial Locations
- Locations (22)
Tom Baker Cancer Centre
🇨🇦Calgary, Alberta, Canada
Cross Cancer Institute
🇨🇦Edmonton, Alberta, Canada
BCCA - Vancouver Island Cancer Centre
🇨🇦Victoria, British Columbia, Canada
The Vitalite Health Network - Dr. Leon Richard
🇨🇦Moncton, New Brunswick, Canada
Regional Health Authority B, Zone 2
🇨🇦Saint John, New Brunswick, Canada
Dr. H. Bliss Murphy Cancer Centre
🇨🇦St. John's, Newfoundland and Labrador, Canada
QEII Health Sciences Centre
🇨🇦Halifax, Nova Scotia, Canada
Juravinski Cancer Centre at Hamilton Health Sciences
🇨🇦Hamilton, Ontario, Canada
Trillium Health Partners - Credit Valley Hospital
🇨🇦Mississauga, Ontario, Canada
Stronach Regional Health Centre at Southlake
🇨🇦Newmarket, Ontario, Canada
Scroll for more (12 remaining)Tom Baker Cancer Centre🇨🇦Calgary, Alberta, Canada