Trial Comparing Simple Follow-up to Exploratory Laparotomy Plus "in Principle" (Hyperthermic Intraperitoneal Chemotherapy) HIPEC in Colorectal Patients
- Conditions
- Ovarian MetastasesColorectal Cancer With a Resected Minimal Synchronous PCTumour Rupture in the Abdominal Cavity
- Interventions
- Procedure: laparotomy plus HIPEC
- Registration Number
- NCT01226394
- Lead Sponsor
- Gustave Roussy, Cancer Campus, Grand Paris
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 130
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.
- 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
- Persons under guardianship 8) Follow-up impossible for geographic, social or psychological reasons
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description laparotomy plus HIPEC. laparotomy plus HIPEC -
- Primary Outcome Measures
Name Time Method To increase the 3-year disease-free survival 3 years 3-year disease-free survival
- Secondary Outcome Measures
Name Time Method Peritoneal disease-free survival 3 years 3 year overall survival 3 years 5 year overall survival 5 years
Trial Locations
- Locations (1)
Institut Gustave Roussy
🇫🇷Villejuif, France