Determining the efficacy and safety of neoadjuvant IP chemotherapy in rectal cancer patients with the spread of disease in peritoneum

Phase 2

Not yet recruiting

• Conditions: Malignant neoplasm of rectum,

• Registration Number: CTRI/2023/11/059575
• Lead Sponsor: Tata Memorial Hospital

Brief Summary

This is a study that will be conducted in rectal cancer patients with distant disease spread to involve peritoneum only. This study will be done for determining the efficacy and safety of intraperitoneal chemotherapy which is delivered directly into the peritoneum i.e the abdominal cavity along with intravenous chemotherapy in rectal cancer patients with peritoneal metastasis.

A total of 92 patients will be enrolled into the study over a period of 3 years. The study will be conducted in 2 phases. The first phase will enroll 10 patients each into the different dosage schedules of intraperitoneal chemotherapy with paclitaxel to find the safe dose of drug to be administered. Then in the next phase total of 72 patients will be evaluated (including 10 patients from the first phase) to look at the efficacy of the intraperitoneal chemotherapy dose that came out to be safe from the first phase of the study.

Patients aged more than 18 years who are diagnosed with confirmed rectal cancer and having evidence of peritoneal disease on staging evaluation will be considered for screening and inclusion into the study. The patients will first undergo a staginglaproscopy procedure to calculate the involvement of peritoneum by cancer by an index called PCI. If the PCI is more than 12 the patients will be screened for eligibility as per the study inclusion and exclusion criteria. After written informed consent the patients will then receive treatment with combined intraperitoneal chemotherapy with a  drug called Paclitaxel and intravenous chemotherapy with a regime called FOLFIRI, both given at 2 weekly intervals. The response to treatment will be then assessed by repeat staging laproscopy procedure done at 8 weeks. The response rates, toxicity rates and survival benefits of the treatment will be estimated at the completion of study recruitment.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2023-02-11
• Study Start: 2023-11-13

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 92

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.
• 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

• 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 reduction	36 months

Secondary Outcome Measures

Name	Time	Method
Conversion to negative peritoneal cytology	Complete cytoreduction rates, Grade 3/4 toxicity rates, DFS, OS.

Trial Locations

Locations (1)

Tata Memorial Centre; 🇮🇳 Mumbai, MAHARASHTRA, India

Tata Memorial Centre

🇮🇳Mumbai, MAHARASHTRA, India

Dr Avanish Saklani

Principal investigator

7400319886

asaklani@hotmail.com