Systemic Chemotherapy With or Without Intraperitoneal Chemohyperthermia in Treating Patients Undergoing Surgery for Peritoneal Carcinomatosis From Colorectal Cancer
Colorectal Cancer, Primary Peritoneal Cavity Cancer
About this trial
This is an interventional treatment trial for Colorectal Cancer focused on measuring recurrent colon cancer, stage IV colon cancer, recurrent rectal cancer, stage IV rectal cancer, peritoneal carcinomatosis
Eligibility Criteria
DISEASE CHARACTERISTICS:
Histologically confirmed colorectal cancer
Peritoneal carcinoma extension ≤ 25 (Sugarbaker Index) (determined intraoperatively)
Planning to receive standard systemic chemotherapy
- Chemotherapy for metastatic cancer should be initiated 3 months after surgery
- No extraperitoneal metastases, including liver and lung metastasis
- No carcinomatosis of other origin besides colorectal, in particular appendical carcinomatosis
- Macroscopically complete resection (R1) or surgical reduction of tumor to a residual thickness ≤ 1 mm (R2) is possible
PATIENT CHARACTERISTICS:
- WHO performance status 0-1
- Life expectancy > 12 weeks
- ANC ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
- AST and ALT ≤ 3 times ULN
- Alkaline phosphatase ≤ 3 times ULN
- Creatinine ≤ 1.25 times ULN
- Eligible for surgery
- No peripheral neuropathy > grade 3
- Not pregnant or nursing
- No other cancer in the past 5 years except basal cell skin cancer or carcinoma in situ of the cervix
- No inability to submit to follow-up medical testing for geographical, social, or psychological reasons
- Affiliated with a social security program
- Not deprived of liberty or under supervision
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior chemohyperthermia
- No concurrent participation in another study of first-line therapy for this cancer
Sites / Locations
- Centre Paul Papin
- Hôpital Antoine Béclère
- CHU Estaing
- Louis Mourier Hospital
- Hopital Du Bocage
- CHU de Grenoble - Hopital de la Tronche
- Centre Leon Berard
- Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
- Centre Regional Rene Gauducheau
- Hopital de l'Archet CHU de Nice
- Institut Curie
- Hopital Lariboisiere
- Hôpital Lariboisière
- Hopital Tenon
- Centre Hospitalier Lyon Sud
- Institut Jean Godinot
- Hopital Universitaire Hautepierre
- Centre Hospitalier Regional de Purpan
- Centre Alexis Vautrin
- Institut Gustave Roussy
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Arm I
Arm II
Patients undergo surgery and receive standard systemic chemotherapy comprising leucovorin calcium IV followed by fluorouracil IV over 30 minutes. Systemic chemotherapy will continue for at least 6 months (before and after surgery). Patients also undergo CHIP comprising oxaliplatin intraperitoneally during surgery and hyperthermia for 30 minutes.
Patients undergo surgery and receive standard systemic chemotherapy comprising leucovorin calcium IV followed by fluorouracil IV over 30 minutes. Systemic chemotherapy will continue for at least 6 months (before and after surgery).