Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Early-Stage Hodgkin's Disease
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00002714|
Recruitment Status : Completed
First Posted : April 6, 2004
Last Update Posted : May 15, 2013
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 chemotherapy drug with radiation therapy may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus radiation therapy in treating patients who have early stage Hodgkin's disease.
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma||Biological: bleomycin sulfate Drug: Stanford V regimen Drug: doxorubicin hydrochloride Drug: etoposide Drug: mechlorethamine hydrochloride Drug: prednisone Drug: vinblastine sulfate Drug: vincristine sulfate Radiation: radiation therapy||Phase 2|
OBJECTIVES: I. Determine the progression-free and overall survival at 5 and 10 years after a short-term Stanford V regimen comprising mechlorethamine, doxorubicin, vinblastine, prednisone, vincristine, bleomycin, and etoposide followed by modified involved-field radiotherapy in patients with favorable, early-stage Hodgkin's disease. II. Determine whether the early and late toxic effects of treatment can be minimized by avoiding staging laparotomy, limiting cumulative doses of chemotherapeutic drugs, and reducing the dose and volume of radiotherapy in these patients. III. Determine the freedom from second disease progression at 5 and 10 years after treatment and treatment-related toxicity in these patients. IV. Determine the quality of life of patients treated with this regimen.
OUTLINE: Patients receive the Stanford V regimen comprising mechlorethamine IV on days 1 and 29; doxorubicin IV and vinblastine IV on days 1, 15, 29, and 43; oral prednisone every other day on days 1-36 followed by tapered doses; vincristine IV and bleomycin IV on days 8, 22, 36, and 50; and etoposide IV on days 15, 16, 43, and 44. Beginning 2 weeks after completion of chemotherapy and when blood counts recover, patients undergo modified involved-field radiotherapy 5 days a week for 3-4 weeks. Quality of life is assessed. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study within 5 years.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||A PHASE II TRIAL OF EIGHT-WEEK STANFORD V CHEMOTHERAPY PLUS MODIFIED INVOLVED FIELD RADIOTHERAPY IN FAVORABLE, LIMITED STAGE HODGKIN'S DISEASE|
|Study Start Date :||April 1995|
|Actual Study Completion Date :||September 2001|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002714
|United States, California|
|Stanford University Medical Center|
|Stanford, California, United States, 94305-5408|
|Study Chair:||Sandra J. Horning, MD||Stanford University|