CTRI/2023/11/059575
Not yet recruiting
Phase 2
Bidirectional intraperitoneal chemotherapy along with systemic chemotherapy in adenocarcinoma of rectum with isolated peritoneal metastasis a prospective study - Nil
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Health Condition 1: C20- Malignant neoplasm of rectum
- Sponsor
- Tata Memorial Hospital
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1 Biopsy proven adenocarcinoma rectum
- •2 Needing laparoscopy (for staging/diversion stoma and/or ovarian transposition prior to cancer directed therapy.
- •3 PCI \> 12 on staging laparoscopy
- •4 Planned for chemotherapy and reassess for curative treatment in MDJC
- •5 ECOG performance status \< 2
- •6 Patient who can give informed consent for the study.
- •7 Patient does not have any contraindications to receive chemotherapy
- •8 Adequate haematological, hepatic and renal function parameters
- •9 haematological\- Hb \> 80 g/L, ANC \= 1\.5 x 109/L, platelets \= 100 x 109/L.
- •11 Liver functions\- bilirubin \= 2 x upper limit normal (ULN), AST/ALT/ALP \=2\. 5 x ULN, S. albumin \= 30 g/L.
Exclusion Criteria
- •Extraperitoneal metastasis based on imaging or biopsy.
- •Patients undergoing upfront definitive resection of primary
- •History of abdominal tuberculosis, significant adhesions in abdomen secondary to previous
- •laparotomy or any other benign pathology
- •Gross ascites, extensive small bowel involvement
- •Known hypersensitivity against 5\-FU, capecitabine, leucovorin, irinotecan
- •Known contraindications against 5\-FU, leucovorin, capecitabine, irinotecan
- •Clinically significant active coronary heart disease, cardiomyopathy or congestive heart failure, NYHA
- •III\-IV, LVEF \<50%.
- •Baseline neuropathy \> NCI Grade I
Outcomes
Primary Outcomes
Not specified
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