Phase III Study Evaluating the Use of Systemic Chemotherapy and Chemohyperthemia Intraperitoneal Preoperatively (CHIP) and After Maximum Resection of Peritoneal Carcinomatosis Originating With Colorectal Cancer
- Compare overall survival of patients with peritoneal carcinoma of colorectal origin
undergoing complete surgical resection and receiving systemic chemotherapy with versus
without intraperitoneal chemohyperthermia.
- Evaluate recurrence-free survival of these patients.
- Evaluate treatment toxicities.
- Determine morbidity from surgical complications.
- Determine prognostic factors of survival.
OUTLINE: This is a multicenter study. Patients are stratified according to participating
center, residual tumor status (R0/R1 vs R2 ≤ 1 mm), prior regimens of systemic chemotherapy
(first vs ≥ second), and preoperative systemic chemotherapy for metastatic disease (yes vs
no). Patients are randomized to 1 of 2 treatment arms.
All patients undergo maximal surgical resection of the tumor.
- Arm I: Patients 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/or after surgery). Patients must stop systemic chemotherapy
at least 1 month before receiving intraperitoneal chemohyperthermia (CHIP). If
bevacizumab is given as neoadjuvant therapy, then systemic chemotherapy must be
discontinued 6 weeks before beginning CHIP. Patients undergo CHIP comprising
oxaliplatin intraperitoneally during surgery and hyperthermia for 30 minutes.
- 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).
Tumor markers (ACE and CA 19-9) are assessed at baseline, at 1 month after surgery, and then
at follow-up visits.
After completion of study therapy, patients are followed at 1 and 3 months, every 3 months
for 3 years, and then every 6 months for 2 years.
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Francois Quenet, MD
Centre Val d'Aurelle - Paul Lamarque