Magnetic Resonance Tumour Regression Grade (mrTRG) as a Novel Biomarker to Stratify Management of Good And Poor Responders To Chemoradiotherapy: A Rectal Cancer Multicentre Randomised Control Trial - TRIGGER Trial Version 1.0

Royal Marsden NHS Foundation Trust0 个研究点目标入组 90 人开始时间: 2015年10月13日最近更新: 2016年4月25日

适应症

试验速览

暂无简介。

•1) Have a biopsy-confirmed adenocarcinoma 0-15cm from the anal verge (on MRI or rigid sigmoidoscopy)
•2) Have locally Advanced Rectal Carcinoma diagnosed by MRI (mrCRM unsafe or =mrT3c [>5mm beyond muscularis propria] or mrEMVI positive disease)
•3) Be deemed to require chemoradiotherapy
•4) Scheduled to receive 45Gy - 55Gy long course radiotherapy
•5) Be aged 18 years or over.
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 45
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 45

•1) Have metastatic disease (including resectable liver metastases)
•2) Are contraindicated for MRI eg. non-mr compatable hip prosthesis, cardiac pacemaker
•3) Are scheduled to receive less than 45Gy or more than 55Gy long course radiotherapy
•4) Are contraindicated for chemoradiotherapy (CRT) or systemic chemotherapy
•5) Are receiving or planned to receive treatment outside of that stipulated by the protocol,such as an alternative cytotoxic or investigational drug.
•6) Are pregnant, breastfeeding or unable / unwilling to comply with pregnancy prevention guidelines
•7) Any other malignant disease within the preceding 5 years with the exception of non- melanomatous skin cancer, carcinoma in situ and early stage disease with <5% recurrence risk

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