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Spots Global Cancer Trial Database for Prophylactic HIPEC for Colorectal Cancers at High Risk of Developing Peritoneal Metastases

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Trial Identification

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

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

Study ID: NCT03422432

Interventions

HIPEC

Study Description

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. 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.

Detailed Description:

Keywords

Eligibility

Minimum Age: 21 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

National Cancer Centre Singapore, Singapore, , Singapore

Contact Details

Name: Grace Tan, MD

Affiliation: National Cancer Centre, Singapore

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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