trial comparing simple follow-up to exploratory laparotomy plus "in principle" (hyperthermic intraperitoneal chemotherapy) hipec in colorectal patients

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

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).


Eligibility criteria:
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 \ 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

Keywords: peritoneal carcinomatosis hipec controlled clinical trial