Two-Week COurse Versus Conventionally Fractionated Preoperative Chemoradiotherapy In Locally Advanced Rectal Cancer (TwoArc Trial): A Phase III Randomized Clinical Trial
试验速览
- 阶段
- 3 期
- 入组人数
- 370
- 试验地点
- 1
- 主要终点
- Tumor response from stage II-III to stage 0-I
研究概览
简要总结
The investigators compare two-week course of chemoradiation (33 Gy in 10 fractions with oral capecitabine) and conventional chemoradiation (50.4 Gy in 28 fractions with 5-FU and leucovorin) in this randomized trial.
详细描述
1.1 experimental arm Two-week course concurrent chemoradiotherapy
- Radiotherapy, 33 Gy/10 fractions for 2 weeks
↓↓↓↓↓ ↓↓↓↓↓ Radical surgery 6 weeks after completion of chemoradiotherapy D1----------------------D12
- Capecitabine 825 mg/m2, twice daily
1.2 control arm
Standard concurrent chemoradiotherapy (CRT)
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
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •histologically confirmed adenocarcinoma;
- •distal margin of the tumor located < 10 cm from the anal verge;
- •cT3-4N0-2 classification as determined by magnetic resonance imaging (MRI) and/or endorectal ultrasonography (EUS);
- •no evidence of distant metastasis;
- •Karnofsky performance score over 70;
- •adequate bone marrow, liver, and renal function (leucocytes >4000/mm3, hemoglobin >10 g/dL, platelets >100,000/mm3; serum bilirubin <1.5 mg/dL, serum transaminase <2.5 times the upper normal limit; serum creatinine <1.5 mg/dL).
排除标准
- •Metastatic disease
- •No complete resection of tumor (R2)
研究组 & 干预措施
Two-week course arm
Experimental arm receive 33 Gy in 10 fractions of radiation for 2 weeks with oral capecitabine.
Two-week course of radiation, 33 Gy/10 fx and oral capecitabine, 825 mg/m2, bid
干预措施: Two-week course of radiation (Drug)
结局指标
主要结局
Tumor response from stage II-III to stage 0-I
时间窗: from clinical staging time to radical surgery date (about 3 months)
Downstaging rate was evaluated by comparing pre-clinical and post-CRT pathological stages, and downstaging was defined as ypStage 0-I (ypT0-2N0M0)
次要结局
- Toxicity (acute and chronic)(from radiation start to 3 years after radical surgery)
- Recurrence and survival(3-year recurrence-free survival and 3-year overall survival)