NCT03422432

Prophylactic HIPEC for Colorectal Cancers at High Risk of Developing Peritoneal Metastases

Pilot Study: Prophylactic Hyperthermic Intraperitoneal Chemotherapy (HIPEC) for Colorectal Cancers at High Risk of Developing Peritoneal Metastases

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: National Cancer Centre, Singapore · Academic / Other
• Sex: All
• Age: 21 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The study investigators hypothesize that prophylactic HIPEC is feasible and well tolerated in patients with colorectal cancers with high-risk of developing peritoneal recurrence. The aim of the pilot study is to test the feasibility of performing prophylactic HIPEC for colorectal cancer patients at high-risk of developing peritoneal recurrence in our institution, and determine the morbidity associated with such a procedure. Patients with high-risk of developing peritoneal recurrence are defined as patients with 1. tumours involving the serosa and adjacent viscera (i.e. T4 cancers) 2. krukenburg tumours (i.e. ovarian metastases) 3. perforated tumours 4. positive peritoneal fluid cytology 5. minimal synchronous PC (nodules \<1cm in the omentum and/or close to the primary tumour). The study investigators plan to assess feasibility according to 1. The number of patients completing the treatment 2. Time to adjuvant systemic chemotherapy, to evaluate if there is delay to adjuvant treatment Morbidity will be measured according to the Clavien-Dindo Classification, and graded according to low versus high grade morbidity. If prophylactic HIPEC is shown to be feasible, with acceptable morbidity, the investigators aim to carry out a randomized controlled trial to determine the effectiveness of prophylactic HIPEC in preventing the development of peritoneal metastases in patients with colorectal cancer at high risk of peritoneal recurrence.

Conditions

• Colorectal Cancer
• Peritoneal Metastases

Interventions

Type	Name	Description
PROCEDURE	HIPEC	All HIPEC will be with Mitomycin C and given at a dose of 10mg/body surface area.

Timeline

• Start date: 2017-09-28
• Primary completion: 2023-09-07
• Completion: 2024-12-13
• First posted: 2018-02-05
• Last updated: 2025-02-03

Locations

1 site across 1 country: Singapore