Trial Comparing Simple Follow-up to Exploratory Laparotomy Plus in Principle (Hyperthermic Intraperitoneal Chemotherapy) HIPEC in Colorectal Patients

Study Overview
=================
Brief 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).

Official Title
-----------------
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

Conditions
-----------------
Colorectal Cancer With a Resected Minimal Synchronous PC, Ovarian Metastases, Tumour Rupture in the Abdominal Cavity

Intervention / Treatment
-----------------
* Procedure: laparotomy plus HIPEC


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A) Patients presenting with the following history: Histologically-proven colorectal adenocarcinoma Presenting at the time of resection of the primary with one of the following 4 criteria (criteria indicating a high risk of developing PC) : Minimal PC, resected at the same time as the primary Ovarian metastases Rupture of the primary tumour inside the peritoneal cavity, Iatrogenic rupture of the primary tumour during surgery B) Who have received standard systemic adjuvant chemotherapy (6 months of systemic chemotherapy) : Chemotherapy with the Folfox 4 regimen (the current standard treatment ; it can be modified in the future in the two groups, if the standard is modified…). Given on an intent-to-treat basis (it can be stopped prematurely for miscellaneous reasons…); C) Patients who do not present any sign of tumour recurrence at the end of these 6 months of chemotherapy. D) Patients with the following general characteristics: Age between 18 and 70 years, Performance Status WHO < 2, life expectancy > 12 weeks, Haematological parameters : Polynuclear neutrophils ³ 1.5x109/L, platelets ³ 100x109/L, Liver function : Total Bilirubin £ 1.5 x ULN, AST (SGOT) et ALT (SGPT) £ 3 x ULN, alkaline phosphatases £ 3 x ULN, Renal function : Plasma creatinine £ 1,25 x ULN, Operable patients, Grade £ 2 peripheral neuropathy (CTC AE v3.0 annex 7) Patients entitled to French National Health Insurance coverage. E)Patients will be informed and a signed consent form will be obtained before initiating any procedure specific to the trial. Exclusion Criteria: Cancers of non colorectal origin, particularly, appendiceal cancers are excluded Patients presenting with a detectable recurrent tumour Grade ≥ 3 Peripheral neuropathy History of cancer (excepted cutaneous basocellullar cancer or in situ carcinoma of the uterine cervix) with a recurrence during the 5 previous years Patients already included in another trial concerning first-line treatment 6) Pregnant women or likely to be pregnant 7) Persons under guardianship 8) Follow-up impossible for geographic, social or psychological reasons

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: surveillance<br> | |
| Experimental: laparotomy plus HIPEC.<br> | Procedure: laparotomy plus HIPEC<br>* Laparotomy + HIPEC<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To increase the 3-year disease-free survival | 3-year disease-free survival | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 3 year overall survival |  | 3 years | 
| Peritoneal disease-free survival |  | 3 years | 
| 5 year overall survival |  | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
peritoneal carcinomatosis, HIPEC, controlled clinical trial