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Phase III Randomized Trial of Chemotherapy with MA/MA (MOPP-ABVD: NM/VCR/PCB/PRED-ADR/BLEO/VBL/DTIC) with vs without Adjuvant Radiotherapy in Patients with Advanced Hodgkin's Disease
Basic Trial Information
Objectives I. Determine whether low-dose radiotherapy increases relapse-free or total survival in patients with advanced stage Hodgkin's disease who have achieved complete responses to alternating non-cross resistant combination chemotherapy with MA/MA: MOPP (mechlorethamine/oncovin/procarbazine/prednisone) alternating with ABVD (adriamycin/bleomycin/vinblastine/dacarbazine). Entry Criteria Disease Characteristics: See General Eligibility Criteria Patient Characteristics: See General Eligibility Criteria General Eligibility Criteria: Patients of any age with histologically confirmed advanced stage Hodgkin's disease who have not had prior therapy or who have relapsed after previous radiotherapy alone. Patients with Ann Arbor clinical Stage IIIA (unequivocally positive lymphangiograms, CT scans, or palpable biopsy-proven disease above and below the diaphragm) and pathologic Stages III (1A or 2A with extensive splenic involvement), III2A, IIIB, and IV are eligible. Previously untreated patients of any stage with large mediastinal mass (greater than 0.3 of the greatest thoracic diameter) are also eligible, but are not randomized. Disease must be measurable. Granulocytes and platelets greater than 500/cumm and 100,000/cumm, respectively, are required. Expected Enrollment 240 patients are expected to enter over 5 years. Outline Randomized study. Patients without significant mediastinal mass (0.3 of the greatest thoracic diameter or less) are randomized to Arms I and II. Patients with mediastinal mass greater than 0.3 of the thoracic diameter are assigned to Arm II. Arm I: 4-Drug Combination Chemotherapy Alternating with 4-Drug Combination Chemotherapy. MA/MA: MOPP: Mechlorethamine, Nitrogen Mustard, NM, NSC-762; Oncovin, Vincristine, VCR, NSC-67574; Procarbazine, PCB, NSC-77213; Prednisone, PRED, NSC-10023; alternating with ABVD: Adriamycin, ADR, NSC-123127; Bleomycin, BLEO, NSC-125066; Vinblastine, VBL, NSC-49842; Dacarbazine, DTIC, NSC-45388. Arm II: 4-Drug Combination Chemotherapy Alternating with 4-Drug Combination Chemotherapy Followed by Radiotherapy. MA/MA; followed by irradiation of all pretreatment sites of disease (except bone marrow) using megavoltage equipment.Published Results Doria R, Holford T, Prosnitz LR, et al.: Second solid tumors (SST) in patients with Hodgkin's disease (HD) after combined modality therapy (CMT). [Abstract] Proceedings of the American Society of Clinical Oncology 13: A-1246, 369, 1994. Trial Lead Organizations Yale Cancer Center
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol. |
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