Determining the efficacy and safety of neoadjuvant IP chemotherapy in rectal cancer patients with the spread of disease in peritoneum
- Conditions
- Health Condition 1: C20- Malignant neoplasm of rectum
- Registration Number
- CTRI/2023/11/059575
- Lead Sponsor
- Tata Memorial Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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.
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.
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Response rates – Proportion of patients having more than 50% PCI reductionTimepoint: 36 months
- Secondary Outcome Measures
Name Time Method Conversion to negative peritoneal cytology <br/ ><br>Complete cytoreduction rates, Grade 3/4 toxicity rates, DFS, OS. <br/ ><br>Timepoint: 36 months