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临床试验/NCT00002714
NCT00002714已完成2 期

A PHASE II TRIAL OF EIGHT-WEEK STANFORD V CHEMOTHERAPY PLUS MODIFIED INVOLVED FIELD RADIOTHERAPY IN FAVORABLE, LIMITED STAGE HODGKIN'S DISEASE

Stanford University2 个研究点 分布在 1 个国家开始时间: 1995年4月最近更新:
适应症
相关药物

试验速览

阶段
2 期
状态
已完成
试验地点
2

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
主要目的
Treatment

入排标准

年龄范围
16 Years 至 60 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究者

申办方类型
Other

研究点 (2)

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