CTIS2024-512526-28-00招募中1 期
Multicentre, open-label, randomized, controlled, parallel arms clinical trial of induction chemotherapy followed by chemoradiotherapy versus chemoradiotherapy alone as neoadjuvant treatment for locally recurrent rectal cancer (PelvEx II) - NL73593.100.20
Catharina Ziekenhuis Stichting0 个研究点目标入组 364 人开始时间: 2024年3月18日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 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
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
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. Expected gross incomplete resection with overt tumour remaining in the patient after resection, encasement of the ischiadic nerve and invasion of the cortex and/or neuroforamina from S2 and upwards are considered not resectable., 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. Patients with enlarged iliac lymph nodes, enlarged inguinal lymph nodes and aspecific lung noduli are not excluded from inclusion., Homozygous DPD deficiency (if known in advance), Any chemotherapy in the past 6 months., Radiotherapy in the past 6 months for primary rectal cancer., Any contraindication for the planned chemotherapy (e.g. severe allergy, pregnancy, kidney dysfunction, thrombocytopenia), as determined by the medical oncologist., 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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