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
Inclusion Criteria:
A) Patients presenting with the following history:
1. Histologically-proven colorectal adenocarcinoma
2. 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:
1. Age between 18 and 70 years,
2. Performance Status WHO < 2, life expectancy > 12 weeks,
3. Haematological parameters : Polynuclear neutrophils ³ 1.5x109/L, platelets ³
100x109/L,
4. Liver function : Total Bilirubin £ 1.5 x ULN, AST (SGOT) et ALT (SGPT) £ 3 x ULN,
alkaline phosphatases £ 3 x ULN,
5. Renal function : Plasma creatinine £ 1,25 x ULN,
6. Operable patients,
7. Grade £ 2 peripheral neuropathy (CTC AE v3.0 annex 7)
8. 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:
1. Cancers of non colorectal origin, particularly, appendiceal cancers are excluded
2. Patients presenting with a detectable recurrent tumour
3. Grade ≥ 3 Peripheral neuropathy
4. History of cancer (excepted cutaneous basocellullar cancer or in situ carcinoma of
the uterine cervix) with a recurrence during the 5 previous years
5. 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