Bidirectional intraperitoneal chemotherapy along with systemic chemotherapy in adenocarcinoma of rectum with isolated peritoneal metastasis a prospective study - Nil

Tata Memorial Hospital0 个研究点目标入组 0 人开始时间: 待定最近更新: 2023年11月13日

试验速览

暂无简介。

•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

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