RT or No RT Following Chemotherapy in Treating Patients With Stage III/IV Hodgkin's Disease
|ClinicalTrials.gov Identifier: NCT00002462|
Recruitment Status : Active, not recruiting
First Posted : July 26, 2004
Last Update Posted : July 27, 2017
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy with combination chemotherapy may kill more tumor cells.
PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with no radiation therapy following chemotherapy in treating patients with stage III or stage IV Hodgkin's disease.
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma||Biological: bleomycin sulfate Drug: doxorubicin hydrochloride Drug: mechlorethamine hydrochloride Drug: prednisone Drug: procarbazine hydrochloride Drug: vinblastine sulfate Drug: vincristine sulfate Radiation: low-LET cobalt-60 gamma ray therapy Radiation: low-LET photon therapy Radiation: radiation therapy||Phase 3|
OBJECTIVES: I. Compare relapse-free survival and overall survival of patients with Stage III/IV Hodgkin's disease randomly assigned to adjuvant involved-field radiotherapy vs. no adjuvant therapy following remission induction with MOPP/ABV (nitrogen mustard/vincristine/procarbazine/prednisone/doxorubicin/bleomycin/vinblastine). II. Evaluate the therapeutic efficacy of MOPP/ABV hybrid chemotherapy in advanced Hodgkin's disease. III. Evaluate the prognostic significance of an early response to MOPP/ABV in patients with advanced Hodgkin's disease.
OUTLINE: Study randomized for adjuvant radiotherapy. All patients receive Induction chemotherapy on Regimen A, following which those in CR are randomized on Arms I and II. Regimen A: 7-Drug Combination Chemotherapy. MOPP/ABV Hybrid. Mechlorethamine, NM, NSC-762; Vincristine, VCR, NSC-67574; Procarbazine, PCB, NSC-77213; Prednisone, PRED, NSC-10023; Doxorubicin, DOX, NSC-123127; Bleomycin, BLEO, NSC-125066; Vinblastine, VBL, NSC-49842. Arm I: Radiotherapy. Involved-field irradiation using megavoltage equipment. Arm II: No further therapy.
PROJECTED ACCRUAL: 321 evaluable patients will be required; an annual accrual rate of 80 patients is anticipated.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||615 participants|
|Official Title:||Phase III Randomized Trial of Adjuvant Involved-Field Radiotherapy vs No Adjuvant Therapy Following Remission Induction With MOPP/ABV Hybrid Chemotherapy in Patients With Stage III/IV Hodgkin's Disease|
|Study Start Date :||September 1989|
|Primary Completion Date :||May 2000|
- Benefit of adjuvant involved field RT after entering complete remission with MOPP/ABV hybrid CT
- Efficacy of MOPP/ABV hybrid CT
- Relapse free survival
- Overall survival
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002462
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|Study Chair:||John Raemaekers, MD, PhD||Universitair Medisch Centrum St. Radboud - Nijmegen|