Health Condition 1: C20- Malignant neoplasm of rectum
Conditions
Interventions
Intervention1: Study Agent
IP Paclitaxel + mFOLFIRI
:
IP chemotherapy
Flemings 1 stage design
10 patients 4 should have response 20 mg per m2 once in 2 weeks
10 patients 4 should have response 40
Sponsors
Tata Memorial Hospital
Eligibility
Inclusion 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 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. 12 Renal function- Creatinine = 1.5 ULN or Creatinine clearance = 40 mL/min. 13 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: 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 Baseline neuropathy > NCI Grade I Chronic inflammatory bowel disease On-treatment participation in another clinical study in the period 30 days prior to inclusion and during the study. Subject pregnant or breast feeding or planning to become pregnant within 6 months. History of cancer diagnosis in the past 5 years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rates – Proportion of patients having more than 50% PCI reductionTimepoint: 36 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Conversion to negative peritoneal cytology Complete cytoreduction rates, Grade 3/4 toxicity rates, DFS, OS. Timepoint: 36 months | — |
Countries
India
Contacts
Public ContactDr Avanish Saklani
Tata Memorial Hospital
Outcome results
None listed