NCT00005584进行中（未招募）3 期
Prospective Controlled Trial in Clinical Stages I-II Supradiaphragmatic Hodgkin's Disease: Evaluation of Treatment Efficacy, (Long Term) Toxicity and Quality of Life in Two Different Prognostic Subgroups
European Organisation for Research and Treatment of Cancer - EORTC121 个研究点 分布在 2 个国家目标入组 1,649 人开始时间: 1998年10月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,649
- 试验地点
- 121
- 主要终点
- Relapse-free rate
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. Combining chemotherapy with radiation therapy may kill more cancer cells. It is not yet known which combination chemotherapy regimen is most effective in treating Hodgkin's lymphoma.
PURPOSE: Randomized phase III trial to compare the effectiveness of different regimens of combination chemotherapy with or without radiation therapy in treating patients who have Hodgkin's lymphoma.
详细描述
OBJECTIVES:
- Compare the late toxicity of 6 courses of epirubicin, bleomycin, vinblastine, and prednisone (EBVP) followed by involved-field radiotherapy (IF-RT) (36 Gy) vs IF-RT (20 Gy), vs no IF-RT (closed to accrual as of 6/2002) in patients with supradiaphragmatic Hodgkin's lymphoma, favorable prognosis, and complete remission (CR) or CR unconfirmed after completion of chemotherapy. (Favorable prognosis group [group 1] closed to accrual as of 4/28/04.)
- Compare 6 courses of doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD) vs 4 courses of ABVD vs 4 courses of cyclophosphamide, doxorubicin, vincristine, bleomycin, etoposide, procarbazine, and prednisone (BEACOPP) followed by IF-RT, with respect to overall survival and late treatment-related toxicity, in patients with supradiaphragmatic Hodgkin's lymphoma and unfavorable prognosis. (Unfavorable prognosis group [group 2] closed to accrual as of 9/2002.) (Favorable prognosis group [group 1] closed to accrual as of 4/28/04.)
- Maintain the failure-free survival and relapse-free survival rates that were reached in the previous EORTC studies (H5 to H8), with a reduction in acute and delayed side effects of the treatment, in particular that of severe late radiotherapy and chemotherapy-related toxicity.
- Compare the quality of life, overall survival, treatment quality control, and duration of treatment in patients with favorable (closed to accrual as of 4/28/04) or unfavorable (closed to accrual as of 9/2002) prognoses treated with these regimens.
- Determine the efficacy of conservative therapy comprised of observation until disease progression (DP) and administration of IF-RT at the time of DP in patients with lymphocyte-predominant Hodgkin's lymphoma, nodular subtype (nodular paragranuloma).
OUTLINE: This is a randomized, multicenter study.
Patients with classical Hodgkin's lymphoma are assigned to 1 of 2 randomized groups. (Group 2 [unfavorable prognosis] closed to accrual as of 9/2002.) (Group 1 [favorable prognosis] closed to accrual as of 4/28/04.) Patients with lymphocyte-predominant Hodgkin's lymphoma are assigned to the nonrandomized group.
Randomized groups
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Randomized groups: Histologically proven previously untreated stage I or II supradiaphragmatic Hodgkin's lymphoma
- •No prior staging laparotomy
- •Favorable (closed to accrual as of 4/28/04) or unfavorable (closed to accrual as of 9/2002) prognosis
- •Nonrandomized group: Histologically proven lymphocyte-predominant Hodgkin's lymphoma, nodular subtype (nodular paragranuloma)
- •Stage I with complete or incomplete resection OR
- •PATIENT CHARACTERISTICS:
- •Performance status:
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •Not specified
- •Not specified
- •Not specified
- •Cardiovascular:
- •No severe cardiac disease that would interfere with normal life expectancy or study treatment
- •No severe pulmonary disease that would interfere with normal life expectancy or study treatment
- •No other prior or concurrent malignancy except basal cell skin cancer or carcinoma in situ of the cervix
- •No severe neurologic or metabolic disease that would interfere with normal life expectancy or study treatment
- •No psychologic, familial, socioeconomic, or geographic circumstances that would preclude proper staging or compliance
- •HIV negative
- •Not pregnant
- •Fertile patients must use effective contraception
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •No prior biologic therapy for this malignancy
- •Chemotherapy
- •No prior chemotherapy for this malignancy
- •Endocrine therapy
- •No prior endocrine therapy for this malignancy
- •Radiotherapy
- •No prior radiotherapy for this malignancy
- •No prior surgery for this malignancy
排除标准
- 未提供
结局指标
主要结局
Relapse-free rate
时间窗: 5 years
with events defined as lack of CR/CRu at the end of treatment or relapse
次要结局
- Overall Survival(Till withdrawal criteria met)
- Failure Free Survival(Till withdrawal criteria met)
- Relapse Free Survival(Till withdrawal criteria met)
研究者
研究点 (121)
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