A phase II Randomized controlled trial comparing short-course radiation and chemotherapy with or without intraperitoneal paclitaxel for locally advanced, non-metastatic signet-ring cell rectal cancers. - NI

Tata Memorial Centre0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年4月29日

试验速览

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•Ability to provide informed consent in English, Hindi or Marathi
•Biopsy proven signet ring cell carcinoma of the rectum
•Non-metastatic on conventional staging investigations that includes contrast enhanced computerized tomography of the chest and abdomen, and magnetic resonance imaging of the pelvis
•Staged at least T3 or T4 with or without radiologically involved mesorectal or lateral pelvic lymph nodes
•Planned for chemotherapy and radiation with curative treatment in the multi-disciplinary joint meeting
•Performance status in the Eastern Cooperative Oncology group less than 2
•Patient who can give informed consent for the study.
•Patient does not have any contra indication storeceive chemotherapy
•Adequate haematological, hepatic and renal function parameters
•Women of child-bearing age should have a negative pregnancy test at the time of randomization and should be willing to use adequate contraception during the treatment phase of the trial.

•Metastatic disease on pretreatment imaging
•Extra pelvic lymph nodal metastasis
•Patients undergoing upfront definitive resection of primary tumour
•History of abdominal tuberculosis, significant adhesions in abdomen secondary to previous laparotomy or any other benign pathology
•Known hyper sensitivity against 5-FU, capecitabine, leucovorin, irinotecan
•Known contra indications against 5-FU, leucovorin, capecitabine, irinotecan
•Clinically significant active coronary heart disease, cardio myopathy or congestive heart failure, NYHA III-IV, LVEF less than 50 percent.
•Baseline neuropathy greater than NCI Grade I
•Chronic inflammatory bowel disease
•Active pregnancy or breast feeding
•History of cancer diagnosis in the past 5 years

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