NCT00028691Unknown3 期
Chlorambucil Versus 2x2 Gy Involved Field Radiotherapy in Stage III/IV Previously Untreated Follicular Lymphoma Patients. A Prospective, Randomized Phase III Clinical Trial
Commissie Voor Klinisch Toegepast Onderzoek22 个研究点 分布在 3 个国家开始时间: 2002年12月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 发起方
- 试验地点
- 22
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer cells. It is not yet known if chlorambucil is more effective than radiation therapy in treating follicular lymphoma.
PURPOSE: Randomized phase III trial to compare the effectiveness of chlorambucil with that of radiation therapy in treating patients who have stage III or stage IV follicular lymphoma that has not been previously treated.
详细描述
OBJECTIVES:
- Compare the effect of chlorambucil vs involved-field radiotherapy on progression-free survival of patients with previously untreated stage III or IV follicular lymphoma.
- Compare the complete and partial remission rates and overall survival of patients treated with these regimens.
- Compare the toxicity of these regimens in these patients.
- Compare the quality of life of patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral chlorambucil on days 1-5. Treatment repeats every 4 weeks for 6-8 courses in the absence of disease progression or unacceptable toxicity.
- Arm II: Patients undergo radiotherapy on days 1 and 3 (and days 15 and 17 for split course).
Quality of life is assessed at baseline, prior to course 3, 6, and 8 (arm I), and then at 4-6 weeks after study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Diagnosis of follicular lymphoma
- •Stage III or IV disease
- •Grades I, II, or III
- •Previously untreated disease
- •Nodal and extranodal sites
- •Bidimensionally measurable disease by physical examination or diagnostic imaging
- •No CNS or orbital non-Hodgkin's lymphoma localization
- •PATIENT CHARACTERISTICS:
- •18 and over (for patients at EORTC centers)
- •65 and over (for patients at HOVON centers)
- •Performance status:
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •WBC at least 4,000/mm^3
- •Platelet count at least 100,000/mm^3
- •Hemoglobin at least 6.0 g/dL
- •Not specified
- •Not specified
- •Cardiovascular:
- •No severe cardiac disease that would preclude study treatment
- •No severe pulmonary disease that would preclude study treatment
- •HIV negative
- •No severe neurologic, psychiatric, or metabolic disease that would preclude study treatment
- •No other prior malignancy except basal cell skin cancer or carcinoma in situ of the cervix
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •Not specified
- •Chemotherapy:
- •Not specified
- •Endocrine therapy:
- •No concurrent systemic corticosteroids, including dexamethasone for nausea and vomiting palliation (inhalation and topical corticosteroids allowed)
- •Radiotherapy:
- •No concurrent elective radiotherapy to an adjacent negative lymph node
- •Not specified
排除标准
- 未提供
研究者
研究点 (22)
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