A phase II Randomized controlled trial A comparison of short-course radiation and chemotherapy with or without intraperitoneal paclitaxel for locally advanced, non-metastatic signet-ring cell rectal cancers
- Conditions
- Health Condition 1: - Health Condition 2: C20- Malignant neoplasm of rectum
- Registration Number
- CTRI/2024/04/065785
- Lead Sponsor
- Tata Memorial Centre
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method