Short course radiotherapy based total neoadjuvent therapy with or without chlorophyllin - SCOTCH study

Tata Memorial Hospital0 个研究点目标入组 0 人开始时间: 待定最近更新: 2023年6月26日

试验速览

暂无简介。

•1.Age > 18 years.
•2.Histologically confirmed diagnosis of adenocarcinoma of the rectum.
•3.Clinical Stage II/III (T2-3, 4b: adherent to prostate, SV or post vagina but not grossly invading, N0-2) based on MRI.
•4.Non-circumferential tumours with craniocaudal length <7 cm
•5.The tumours of the lower rectum, or starting up to 7 cm from the anal verge.
•6.No evidence of distant metastases on CT Chest and Abdomen.
•7.No prior pelvic radiation therapy
•8.No prior chemotherapy or surgery for rectal cancer
•9.ECOG Performance status 0-2
•10.Patients must read, agree to, and sign a statement of Informed Consent prior to participation in this study.
•11.Eligible to receive one of the options of standard neoadjuvant chemotherapy as determined by the medical oncologist team.
•11.1. ANC > 1.5 cells/mm3, HGB > 8.0 gm/dl, PLT > 150,000/mm3.
•11.2. Total bilirubin <= 1.5 x ULN (except in patients with Gilbertâ??s Syndrome who must have total bilirubin <= 3.0 x ULN), AST<= 3 x ULN, ALT <= 3 x ULN.

•-Signet or mucinous histology cancer of rectum
•-Recurrent rectal cancer or previous pelvic radiotherapy
•-Primary unresectable rectal cancer.
•-Creatinine level greater than 1.5 times the upper limit of normal.
•-Patients who are unable to undergo an MRI.
•-Patients with a history of any arterial thrombotic event within the past 6 months. This includes angina stable or unstable, MI, TIA, or CVA.
•-Ulcerative colitis or any other histologically confirmed inflammatory bowel disease.
•-Patients with a history of venous thrombotic episodes such as deep venous thrombosis, and pulmonary embolism occurring more than 6 months prior to enrollment may be considered for protocol participation, provided they are on stable doses of anticoagulant therapy. Similarly, patients who are anticoagulated for a trial fibrillation or other conditions may participate, provided they are on stable doses of anticoagulant therapy.
•-Patients with any other concurrent medical or psychiatric condition or disease which, in the investigators judgment would make them inappropriate candidates for entry into this study.
•-Poor reliability for follow up.
•-Ineligible as per eligibility criteria

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