NCT00002561

Radiation Therapy and Chemotherapy in Treating Patients With Hodgkin's Disease

A Phase III Study of Radiotherapy or ABVD Plus Radiotherapy Versus ABVD Alone in the Treatment of Early Stage Hodgkin's Disease

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 405 (actual)
• Sponsor: NCIC Clinical Trials Group · Network
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hodgkin Lymphoma

Interventions

Type	Name	Description
BIOLOGICAL	bleomycin sulfate	10 units/m2
DRUG	dacarbazine	375mg/m2
DRUG	doxorubicin hydrochloride	25mg/m2
DRUG	vinblastine	6mg/m2
RADIATION	radiation therapy	35Gy in 20 fractions (daily)

Timeline

• Start date: 1994-01-25
• Primary completion: 2011-08-15
• Completion: 2012-01-06
• First posted: 2003-11-21
• Last updated: 2020-04-14

Locations

22 sites across 3 countries: Canada, Italy, United Kingdom