Trials / Completed
CompletedNCT01226394
Trial Comparing Simple Follow-up to Exploratory Laparotomy Plus "in Principle" (Hyperthermic Intraperitoneal Chemotherapy) HIPEC in Colorectal Patients
Multicentric Phase III Trial Comparing Simple Follow-up to Exploratory Laparotomy Plus "in Principle" HIPEC (Hyperthermic Intraperitoneal Chemotherapy) in Colorectal Patients Initially Treated With Surgery and Adjuvant Chemotherapy Who Have a High Risk of Developing Colorectal Peritoneal Carcinomatosis
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 150 (actual)
- Sponsor
- Gustave Roussy, Cancer Campus, Grand Paris · Academic / Other
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
Multicentric randomised trial. Patients with a high risk of developing colorectal Peritoneal Carcinomatosis (PC) after resection of their primary will be informed, will sign the consent and will be pre-registered. All patients will receive the current standard adjuvant treatment : 6 months of systemic chemotherapy (currently the Folfox-4 regimen which could be modified if the standard is modified). Then a work-up is done to exclude recurrence. The likelihood of a recurrence is low but if this occurs, the patient will not be randomised and will be treated with the best known treatment. If the work-up is negative, patients will be randomised to surveillance alone (control group) or exploratory laparotomy + HIPEC (experimental group).
Conditions
- Colorectal Cancer With a Resected Minimal Synchronous PC
- Ovarian Metastases
- Tumour Rupture in the Abdominal Cavity
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | laparotomy plus HIPEC | Laparotomy + HIPEC |
Timeline
- Start date
- 2010-06-11
- Primary completion
- 2018-03-19
- Completion
- 2021-01-07
- First posted
- 2010-10-22
- Last updated
- 2026-04-06
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT01226394. Inclusion in this directory is not an endorsement.