Health Condition 1: - Health Condition 2: C20- Malignant neoplasm of rectum
Conditions
Interventions
Intervention1: Study agent for standard arm SCRT +IP FOLFOX +Oxaliplatin+ Leucovorin
Study agent for experimental arm-SCRT+FOLFIRI+Irinotecan+Leucovorin and 5-FU: Patients randomized to the standard
Sponsors
Tata Memorial Centre
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1-year DFS reduction in treatment failures defined as a composite of default, progressions, inoperability, R2 resections, recurrences, and death due to any causeTimepoint: 1-year | — |
Secondary
| Measure | Time frame |
|---|---|
| 1)Treatment toxicity on the CTCAE version 5.0 2)2-year overall survival 3)Quality of life using the EORTC-QLQ-C 30 and EORTC-QLQ-CR29 at 1-year Timepoint: 1-year | — |
Countries
India
Contacts
Public ContactDrAvanish Saklani
tata memorial hospital dr ernest borges marg parel mumbai
Outcome results
None listed