NL-OMON54232招募中3 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
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 250
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •18 years or older
- •Confirmed locally recurrent rectal cancer after total or partial mesorectal
- •resection for rectal cancer 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 systemic metastatic disease (e.g. liver, lung) at
- •time of randomisation or in the six months prior to randomisation
- •Homozygous DPD deficiency (if known in advance)
- •Any chemotherapy in the past 6 months
- •Any contraindication for the planned chemotherapy chemotherapy (e.g. severe
- •allergy, pregnancy, kidney dysfunction, thrombocytopenia), 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
- •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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