Status:
COMPLETED
Prophylactic HIPEC for Colorectal Cancers at High Risk of Developing Peritoneal Metastases
Lead Sponsor:
National Cancer Centre, Singapore
Conditions:
Colorectal Cancer
Peritoneal Metastases
Eligibility:
All Genders
21-75 years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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.
- All patients diagnosed with adenocarcinoma of the colon and rectum, and either one of the five following risk factors for peritoneal metastases will be considered for inclusion:
- 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
- Other inclusion criteria:
- 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
Exclusion
- 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
Key Trial Info
Start Date :
September 28 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 13 2024
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT03422432
Start Date
September 28 2017
End Date
December 13 2024
Last Update
February 3 2025
Active Locations (1)
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1
National Cancer Centre Singapore
Singapore, Singapore, Singapore, 169610