Risk-Adapted Stanford V-C With Radiotherapy for Clinical Stage I and IIA Favorable Hodgkin's Disease: The G5 Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 76
- 试验地点
- 2
- 主要终点
- Progression-free Survival (PFS)
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 tumor cells. Combining chemotherapy with radiation therapy may kill more tumor cells.
PURPOSE: This phase 2 trial is studying how well giving combination chemotherapy together with low-dose radiation therapy works in treating patients with stage I or stage IIA Hodgkin's lymphoma.
详细描述
OBJECTIVES:
- Evaluate the freedom from progression in patients with stage I or IIA Hodgkin's lymphoma with a favorable prognosis treated with "Stanford V-C" chemotherapy comprising cyclophosphamide, doxorubicin, vinblastine, prednisone, vincristine, bleomycin, and etoposide with low-dose radiotherapy (RT).
- Minimize the early and late effects of treatment in these patients by avoiding staging laparotomy and its consequences, limiting cumulative doses of chemotherapy, and reducing the dose of RT to moderately bulky sites of disease.
- Assess early and late treatment-related toxicity, freedom from second disease progression, and overall survival at 5 and 10 years in patients treated with this regimen.
Participants receive Stanford V-C chemotherapy comprising cyclophosphamide IV over 30 to 60 minutes weekly on weeks 1 and 5; doxorubicin IV and vinblastine IV over 5 minutes once weekly on weeks 1, 3, 5, and 7; oral prednisone every other day on weeks 1 to 8; vincristine IV, and bleomycin IV over 5 minutes once weekly on weeks 2, 4, 6, and 8; and etoposide IV over 60 minutes on days 1 and 2 of weeks 3 and 7. Prior to protocol amendment, participants were assigned to treatment on the basis of tumor size (< 5 cm vs 5 to 10 cm), with only the participants with larger tumors receiving RT. Beginning 2 to 3 weeks after completion of chemotherapy, participants in the +RT group will receive low-dose radiotherapy 5 days a week for approximately 3 weeks. Subsequent to amendment, all participants received RT.
Participants are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Stanford V-C + Low-dose Radiotherapy
"Sanford V-C" = Vinblastine, cyclophosphamide, doxorubicin, prednisone, bleomycin, + etoposide.
Radiotherapy = 20 Gy modified involved field radiotherapy
干预措施: Vincristine (Drug)
Stanford V-C + Low-dose Radiotherapy
"Sanford V-C" = Vinblastine, cyclophosphamide, doxorubicin, prednisone, bleomycin, + etoposide.
Radiotherapy = 20 Gy modified involved field radiotherapy
干预措施: Cyclophosphamide (Drug)
Stanford V-C + Low-dose Radiotherapy
"Sanford V-C" = Vinblastine, cyclophosphamide, doxorubicin, prednisone, bleomycin, + etoposide.
Radiotherapy = 20 Gy modified involved field radiotherapy
干预措施: Low-dose radiotherapy (RT) (Radiation)
Stanford V-C + Low-dose Radiotherapy
"Sanford V-C" = Vinblastine, cyclophosphamide, doxorubicin, prednisone, bleomycin, + etoposide.
Radiotherapy = 20 Gy modified involved field radiotherapy
干预措施: Doxorubicin (Drug)
Stanford V-C + Low-dose Radiotherapy
"Sanford V-C" = Vinblastine, cyclophosphamide, doxorubicin, prednisone, bleomycin, + etoposide.
Radiotherapy = 20 Gy modified involved field radiotherapy
干预措施: Prednisone (Drug)
Stanford V-C + Low-dose Radiotherapy
"Sanford V-C" = Vinblastine, cyclophosphamide, doxorubicin, prednisone, bleomycin, + etoposide.
Radiotherapy = 20 Gy modified involved field radiotherapy
干预措施: Bleomycin (Drug)
Stanford V-C + Low-dose Radiotherapy
"Sanford V-C" = Vinblastine, cyclophosphamide, doxorubicin, prednisone, bleomycin, + etoposide.
Radiotherapy = 20 Gy modified involved field radiotherapy
干预措施: Etoposide (Drug)
Stanford V-C only
"Sanford V-C" = Vinblastine, cyclophosphamide, doxorubicin, prednisone, bleomycin, + etoposide.
干预措施: Vincristine (Drug)
Stanford V-C only
"Sanford V-C" = Vinblastine, cyclophosphamide, doxorubicin, prednisone, bleomycin, + etoposide.
干预措施: Cyclophosphamide (Drug)
Stanford V-C only
"Sanford V-C" = Vinblastine, cyclophosphamide, doxorubicin, prednisone, bleomycin, + etoposide.
干预措施: Doxorubicin (Drug)
Stanford V-C only
"Sanford V-C" = Vinblastine, cyclophosphamide, doxorubicin, prednisone, bleomycin, + etoposide.
干预措施: Prednisone (Drug)
Stanford V-C only
"Sanford V-C" = Vinblastine, cyclophosphamide, doxorubicin, prednisone, bleomycin, + etoposide.
干预措施: Bleomycin (Drug)
Stanford V-C only
"Sanford V-C" = Vinblastine, cyclophosphamide, doxorubicin, prednisone, bleomycin, + etoposide.
干预措施: Etoposide (Drug)
结局指标
主要结局
Progression-free Survival (PFS)
时间窗: up to 3 years
Progression-free survival was assessed for 3 years from the completion of treatment. Progression-free survival was considered to mean the proportion of patients (percentage) still alive without disease recurrence or progression.
次要结局
- Early Treatment-related Toxicity(Within 30 days of treatment)
- Frequency of Complete Response(5 weeks)
- Late Treatment-related Toxicity(16 years)
- Second Hodgkin's Disease Progression(16 years)
- Overall Survival (OS)(16 years)
- Survival at 5 and 10 Years(5 and 10 years)
研究者
Ranjana Advani
Saul A. Rosenberg, MD, Professor of Lymphoma
Stanford University