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

NCT03422432 | Completed DMC

• 1 other identifier: 2017/2402/B
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief 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. 1.tumours involving the serosa and adjacent viscera (i.e. T4 cancers)
2. 2.krukenburg tumours (i.e. ovarian metastases)
3. 3.perforated tumours
4. 4.positive peritoneal fluid cytology
5. 5.minimal synchronous PC (nodules \<1cm in the omentum and/or close to the primary tumour).
6. 6.The number of patients completing the treatment
7. 7.Time to adjuvant systemic chemotherapy, to evaluate if there is delay to adjuvant treatment

Conditions

Colorectal Cancer; Peritoneal Metastases

Outcome Measures

Primary Outcomes (2)

• The number of patients completing the treatment

  From start to end of study, approximately 1 year

• Time to adjuvant systemic chemotherapy

  To evaluate if there is delay to adjuvant treatment

  3 months from date of surgery

Study Arms (2)

Group 1

EXPERIMENTAL

Patients are identified pre-operatively on radiological imaging. Prophylactic HIPEC will be delivered intra-operatively, immediately after the resection of the primary tumour, and only if the patient is deemed well enough to receive the HIPEC.

Procedure: HIPEC

Group 2

EXPERIMENTAL

Patients are identified post-operative based on histological findings. They will be counselled to receive prophylactic HIPEC only. If peritoneal nodules are found during surgery, these patients will be excluded from the study.

Procedure: HIPEC

Interventions

HIPEC PROCEDURE

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

Group 1; Group 2

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Two groups of patients may be enrolled:
• Group 1 patients are identified pre-operatively on radiological imaging, while Group 2 patients are identified post-operative based on histological findings.
• T4 tumours - in Group 1, this would consist of obvious clinical T4 stage based on preoperative imaging, and in Group 2, this would be on pathological confirmation of a T4 tumour.
• Krukenburg tumours - Unilateral or bilateral ovarian masses seen on preoperative imaging
• Perforated tumours - in Group 1, this would consist of patients presenting with perforation on preoperative imaging, and undergoing curative resection, and in Group 2, this would be on pathological or intra-operative confirmation of a perforated tumour.
• Limited synchronous peritoneal metastases (peritoneal nodules \<1cm in the omentum and/or close to the tumour). Patients with limited peritoneal disease in close proximity to the primary tumour, that may be removed enbloc with the primary resection can be included, but patients with more extensive peritoneal disease and those with extra-peritoneal metastases i.e. liver and/or lung metastases will be excluded from the study.
• Positive cytology in Group 2 patients
• Patients must be between the ages of 21 and 75 years
• Patients must be in a stable clinical condition to undergo simultaneous HIPEC after the primary curative colorectal resection
• Patients must have an ECOG performance status 0 or 1
• Patients must have normal organ and marrow function as defined below:
• i. Absolute neutrophil count \> 1.5 x 109/L ii. Platelets \> 100 x 109/L iii. Haemoglobin \> 9.0g/dl iv. Total bilirubin ≤1.5 x ULN v. AST(SGOT)/ALT(SGPT) \< 3 X institutional ULN vi. Creatinine ≤1.5 x upper limit of normal (ULN) OR vii. Creatinine clearance ≥60 mL/min for patients with creatinine levels \>1.5 x institutional UL e. Patients must have a normal coagulation profile f. Patients must give written informed consent

You may not qualify if:

• Patients who are not fit to give consent for the procedure
• Patients who are not fit to undergo surgery
• Patients who are pregnant
• Patients who have extensive synchronous peritoneal disease
• Patients with extra-peritoneal metastases i.e. liver and/or lung metastases

Sponsors & Collaborators

• National Cancer Centre, Singapore: lead

Study Sites (1)

National Cancer Centre Singapore

Singapore, Singapore, 169610, Singapore

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Hyperthermic Intraperitoneal Chemotherapy

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Chemotherapy, Adjuvant; Combined Modality Therapy; Therapeutics; Drug Therapy; Hyperthermia, Induced

Study Officials

• Grace Tan, MD

  National Cancer Centre, Singapore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2018
• First Posted: February 5, 2018
• Study Start: September 28, 2017
• Primary Completion: September 7, 2023
• Study Completion: December 13, 2024
• Last Updated: February 3, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)