A Phase II Evaluation of Dose-Painted Intensity-Modulated Radiation Therapy (IMRT) in Combination With 5-Fluorouracil (5-FU) and Mitomycin-C for Reduction of Acute Morbidity in Carcinoma of the Anal Canal
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 63
- 试验地点
- 172
- 主要终点
- Percentage of Subjects With Acute Gastrointestinal (GI) and Genitourinary (GU) Adverse Events (AE) ≥ Grade 2 as Defined by CTCAE v3.0 (Common Terminology Criteria for Adverse Events)
研究概览
简要总结
RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy, such as fluorouracil and mitomycin C, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy together with 5-fluorouracil (5-FU) and mitomycin C may kill more tumor cells.
PURPOSE: This phase II trial is studying the side effects and how well giving intensity-modulated radiation therapy together with fluorouracil and mitomycin C works in treating patients with invasive anal cancer.
详细描述
OBJECTIVES:
Primary
- Determine if dose-painted, intensity-modulated radiation therapy (IMRT), fluorouracil, and mitomycin C decreases the combined rate of gastrointestinal and genitourinary adverse events (grade II or greater) by at least 15% in the first 90 days after the start of treatment in patients with primary invasive carcinoma of the anal canal compared to patients treated on the radiotherapy, fluorouracil, and mitomycin C arm on clinical trial RTOG 98-11.
Secondary
- Determine the feasibility of performing IMRT in these patients in a cooperative group setting.
- Evaluate adverse events experienced by patients treated with this regimen and to decrease the grade 2 and higher and grade 3 and higher overall adverse event rates by 15% or 20% as compared to the radiotherapy and mitomycin C arm of RTOG 98-11.
- Evaluate the total duration of radiotherapy.
- Evaluate the efficacy of this regimen, in terms of locoregional failure, disease-free survival, time to colostomy, colostomy-free survival, and overall survival of these patients.
- Determine clinical complete response at 8 weeks after completion of study treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 120 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
5-FU + Mitomycin + IMRT
5-FU + Mitomycin + IMRT
干预措施: fluorouracil (Drug)
5-FU + Mitomycin + IMRT
5-FU + Mitomycin + IMRT
干预措施: mitomycin C (Drug)
5-FU + Mitomycin + IMRT
5-FU + Mitomycin + IMRT
干预措施: Intensity-modulated radiation therapy (Radiation)
结局指标
主要结局
Percentage of Subjects With Acute Gastrointestinal (GI) and Genitourinary (GU) Adverse Events (AE) ≥ Grade 2 as Defined by CTCAE v3.0 (Common Terminology Criteria for Adverse Events)
时间窗: From the start of treatment to 90 days
Highest grade adverse event per subject were counted. Adverse events were graded using CTCAE v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE. Acute toxicities occur within 90 days of the start of treatment.
次要结局
- Five-year Rate of Overall Survival(From registration to 5 years)
- Number of Patients With Major Radiation Planning Deviations(Planning occurred prior to radiation therapy)
- Percentage of Subjects With Acute Adverse Events (AE)(From the start of treatment to 90 days)
- Percentage of Subjects With Late Adverse Events (AE)(From 91 days after start of study treatment to the end of follow-up. Maximum follow-up at time of analysis was 9.2 years.)
- Clinical Complete Response Rate(8 and 12 weeks after treatment completion (corresponding to 14 and 18 weeks from registration))
- Five-year Rate of Disease-free Survival(From registration to 5 years)
- Five-Year Rate of Colostomy-free Survival(From registration to 5 years)
- Duration of Radiotherapy Treatment(From start to end of radiation therapy (6 weeks))
- Five-Year Cumulative Incidence Rate of Local-regional Failure(From registration to 5 years)
- Five-Year Cumulative Incidence Rate of Distant Failure(From registration to 5 years)
- Five-Year Cumulative Incidence Rate of Colostomy Failure(From registration to 5 years)