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Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Early-Stage Hodgkin's Disease

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00002714
First received: November 1, 1999
Last updated: May 14, 2013
Last verified: September 2001

November 1, 1999
May 14, 2013
April 1995
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Complete list of historical versions of study NCT00002714 on ClinicalTrials.gov Archive Site
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Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Early-Stage Hodgkin's Disease
A PHASE II TRIAL OF EIGHT-WEEK STANFORD V CHEMOTHERAPY PLUS MODIFIED INVOLVED FIELD RADIOTHERAPY IN FAVORABLE, LIMITED STAGE HODGKIN'S DISEASE

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.

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.

Interventional
Phase 2
Primary Purpose: Treatment
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
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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September 2001
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DISEASE CHARACTERISTICS: Histologically proven stage I-IIA Hodgkin's disease No lymphocyte predominant disease No stage IA high neck presentation (above the top of the larynx) No mediastinal mass equal to or greater than one-third the maximum intrathoracic diameter on chest x-ray No constitutional (B) symptoms at diagnosis No more than 1 extranodal site of disease

PATIENT CHARACTERISTICS: Age: 16 to 60 Performance status: Not specified Hematopoietic: Granulocyte count at least 2,000/mm3 Platelet count at least 150,000/mm3 Hepatic: Bilirubin no greater than 2.5 mg/dL Renal: Creatinine no greater than 2 mg/dL Other: No other medical condition that would preclude study therapy HIV negative No other prior malignancy except basal cell skin cancer Not pregnant

PRIOR CONCURRENT THERAPY: No prior therapy for Hodgkin's disease No other concurrent antineoplastic therapy No other concurrent investigational drugs

Both
16 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00002714
SUMC-G4, CDR0000064550, NCI-H96-0805
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Stanford University
National Cancer Institute (NCI)
Study Chair: Sandra J. Horning, MD Stanford University
National Cancer Institute (NCI)
September 2001

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP