Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 9:34 PM
Ignite Modification Date:
2025-12-24 @ 9:34 PM
NCT ID:
NCT03422432
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.
Study:
NCT03422432
Study Brief:
Protocol Section:
NCT03422432