Randomized Phase II Study of Adjuvant Chemotherapy With 5-FU/Leucovorin vs. Oxaliplatin/5-FU/Leucovorin After Preoperative Chemoradiotherapy With Fluoropyrimidines Followed by Surgery in Patients With Locally Advanced Rectal Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 322
- 试验地点
- 6
- 主要终点
- Number of Participants With Disease Recurrence
研究概览
简要总结
The purpose of this study is to evaluate the disease-free survival in patients with locally advanced rectal cancer treated with preoperative chemoradiotherapy with fluoropyrimidines and surgery followed by adjuvant combination chemotherapy with oxaliplatin/5-FU/Leucovorin vs 5-FU/Leucovorin.
详细描述
Preoperative chemoradiotherapy with fluoropyrimidines followed by surgery is one of the standard treatments for patients with locally advanced rectal cancer; however, the role of adjuvant chemotherapy is still controversial. The aim of this study is to investigate the efficacy of adjuvant FOLFOX for rectal cancer who underwent fluoropyrimidine based chemoradiotherapy and complete total mesorectal excision.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed adenocarcinoma of the rectum
- •Patients who treated with preoperative chemoradiation with fluoropyrimidines followed by curative surgery without microscopic residual tumor.
- •AJCC/UICC pathologic stages of ypT3-4 or ypN+
- •Curative surgery not less than 3 and not more than 8 weeks prior to randomization
- •No prior chemotherapy, radiotherapy and immunotherapy except preoperative chemoradiation for rectal cancer
- •ECOG PS 0-1
- •Adequate organ function
- •Informed Consent
排除标准
- •Macroscopic or microscopic evidence of remaining tumor
- •Any histologic feature other than adenocarcinoma or arisen from chronic inflammatory bowel disease
- •More than 8 weeks after curative surgery
研究组 & 干预措施
Adjuvant FL
FL (5-FU 380 mg/m2, leucovorin 20 mg/m2 on D1-5 q 4 weeks X 4 cycles)
干预措施: Adjuvant FL (Drug)
Adjuvant FOLFOX
FOLFOX (oxaliplatin 85 mg/m2, leucovorin 200 mg/m2 on D1, 5-FU bolus 400 mg/m2 on D1, 5-FU infusion 2400 mg/m2 for 46 hours q 2 weeks X 8 cycles)
干预措施: Adjuvant FOLFOX (Drug)
结局指标
主要结局
Number of Participants With Disease Recurrence
时间窗: up to 3 years after completion of treatment
Disease-free survival will be measured as the time from the date of randomization to the date of disease relapse or death due to any cause. Using Cox-proportional hazard regression, the hazard ratio together with the 95% confidence interval will be reported, in addition to Kaplan-Meier estimates of the survival curves, including medians and rates with 95% confidence intervals. Intent-to-treat population included all randomised patients, and per-protocol population included patients who received at least 1 dose of chemotherapy without any violation of inclusion criteria
Number of Participants With Disease Recurrence With Pathological Stage III
时间窗: up to 3 years after completion of treatment
Disease-free survival will be measured as the time from the date of randomization to the date of disease relapse or death due to any cause. Using Cox-proportional hazard regression, the hazard ratio together with the 95% confidence interval will be reported, in addition to Kaplan-Meier estimates of the survival curves, including medians and rates with 95% confidence intervals. Intent-to-treat population included all randomised patients, and per-protocol population included patients who received at least 1 dose of chemotherapy without any violation of inclusion criteria.
Number of Participants With Disease Recurrence With Pathological Stage II
时间窗: up to 3 years after completion of treatment
Disease-free survival will be measured as the time from the date of randomization to the date of disease relapse or death due to any cause. Using Cox-proportional hazard regression, the hazard ratio together with the 95% confidence interval will be reported, in addition to Kaplan-Meier estimates of the survival curves, including medians and rates with 95% confidence intervals. Intent-to-treat population included all randomised patients, and per-protocol population included patients who received at least 1 dose of chemotherapy without any violation of inclusion criteria.
次要结局
- Death Rate(Up to 3 years after completion of treatment.)
- Pattern of Recurrence(the time from the date of randomization to the date of disease relapse, , assessed up to 5 years)
研究者
Tae Won Kim
Professor
Asan Medical Center