Multicentre, Open-label, Randomised, Controlled, Parallel Arms Clinical Trial of Induction Chemotherapy Followed by Chemoradiotherapy Versus Chemoradiotherapy Alone as Neoadjuvant Treatment for Locally Recurrent Rectal Cancer - PelvEx II
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 364
- 试验地点
- 14
- 主要终点
- Proportion of patients with a clear resection margin
研究概览
简要总结
This is a multicentre, open-label, parallel arms, phase IIII study that randomises patients with locally recurrent rectal cancer in a 1:1 ratio to receive either induction chemotherapy followed by neoadjuvant chemoradiotherapy and surgery (experimental arm) or neoadjuvant chemoradiotherapy and surgery alone (control arm)
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
- •18 years or older
- •Confirmed locally recurrent rectal cancer after total or partial mesorectal resection for rectal or distal sigmoidal cancer either by histopathology ór clinically proven (evidence on imaging in combination with clinical findings, with consensus in MDT)
- •Resectable disease determined by magnetic resonance imaging (MRI) or deemed resectable after neoadjuvant treatment with chemoradiotherapy.
- •WHO performance score 0-1
- •Written informed consent
排除标准
- •Radiological evidence of metastatic disease (e.g. liver, lung) at time of randomisation or in the six months prior to randomisation.
- •Known homozygous DPD deficiency
- •Any chemotherapy in the past 6 months.
- •Any contraindication for the planned chemotherapy, as determined by the medical oncologist.
- •Radiotherapy in the past 6 months for primary rectal cancer.
- •Any contraindication for the planned chemoradiotherapy, as determined by the medical oncologist and/or radiation oncologist.
- •Any contraindication for surgery, as determined by the surgeon and/or anaesthesiologist.
- •Concurrent malignancies that interfere with the planned study treatment or the prognosis of resected LRRC.
研究组 & 干预措施
Induction chemotherapy + chemoradiotherapy + surgery
Induction chemotherapy followed by neoadjuvant chemoradiotherapy and surgery
干预措施: Combination drug (Drug)
Induction chemotherapy + chemoradiotherapy + surgery
Induction chemotherapy followed by neoadjuvant chemoradiotherapy and surgery
干预措施: Chemoradiotherapy (Radiation)
Induction chemotherapy + chemoradiotherapy + surgery
Induction chemotherapy followed by neoadjuvant chemoradiotherapy and surgery
干预措施: Surgery locally recurrent rectal cancer (Procedure)
Neoadjuvant chemotherapy + surgery
Neoadjuvant chemoradiotherapy followed by surgery
干预措施: Chemoradiotherapy (Radiation)
Neoadjuvant chemotherapy + surgery
Neoadjuvant chemoradiotherapy followed by surgery
干预措施: Surgery locally recurrent rectal cancer (Procedure)
结局指标
主要结局
Proportion of patients with a clear resection margin
时间窗: Scored within 1 one month of surgery
A resection margin is considered clear (R0), if there are no tumour cells in any of the resection surfaces as determined by microscopy (resection margin \> 0mm)
次要结局
- Local recurrence free survival(Assessed up to 5 years)
- Progression free survival(Assessed up to 5 years)
- Metastasis free survival(Assessed up to 5 years)
- Overall survival(Assessed up to 5 years)
- Toxicity induction chemotherapy(Scored until one month after the last administration of the chemotherapy)
- Major surgical morbidity(30 and 90-days postoperative)
- Radiological response(Restaging is performed after 3 cycles of CAPOX (1 cycle is 3 weeks) or 4 cycles of CAPOX/FOLFOX (1 cycle is 2 weeks). Second restaging is performed 4-6 weeks after finishing chemoradiotherapy)
- Cost-effectiveness(at baseline, 3 months and 12 months postoperative)
- Disease free survival(Assessed up to 5 years)
- Pathologic response(Scored within 1 month of surgery)
- Toxicity chemoradiotherapy(Scored until 3 months after the last administration of the radiotherapy)
- Compliance chemoradiotherapy(Evaluation at time of surgery)
- Surgical characteristics(Evaluation directly postoperative)
- Colorectal cancer specific quality of life(at baseline, 3 months and 12 months postoperative)
- Number of patients undergoing surgery(Surgery is scheduled 10-14 weeks after finishing chemoradiotherapy)
- Cancer specific quality of life(at baseline, 3 months and 12 months postoperative)
- Compliance induction chemotherapy(Scored within 1 month after start chemoradiotherapy)
研究者
J. W. A. Burger
MD, PhD
Catharina Ziekenhuis Eindhoven