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

NCT03422432 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2025-02-03

No results posted yet for this study

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

Interventions

PROCEDURE

HIPEC

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

Sponsors & Collaborators

  • National Cancer Centre, Singapore

    lead OTHER

Principal Investigators

  • Grace Tan, MD · National Cancer Centre, Singapore

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-28
Primary Completion
2023-09-07
Completion
2024-12-13

Countries

  • Singapore

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03422432 on ClinicalTrials.gov