EUCTR2020-002141-42-PT进行中（未招募）1 期
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 study - PelvEx II
Catharina Hospital0 个研究点目标入组 364 人开始时间: 2021年6月17日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 364
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •18 years or older
- •Confirmed local recurrent rectal cancer after total or partial mesorectal resection for rectal 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
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 182
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 182
排除标准
- •Radiological evidence of systemic metastatic disease (e.g. liver, lung) at time of randomisation or in the six months prior to randomisation
- •Homozygous DPD deficiency
- •Any chemotherapy in the past 6 months
- •Any contraindication for the planned chemotherapy (e.g. severe allergy, pregnancy, kidney dysfunction with creatinine clearance of <30ml/min, thrombocytopenia of <100x109/L), as determined by the medical oncologist
- •Radiotherapy in the past 6 months for primary rectal cancer
- •Any contraindication for the planned chemoradiotherapy (e.g. severe allergy to chemotherapy agent, no possibility for radiotherapy due to previous radiotherapy), 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.
研究者
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