Systemic Chemotherapy With or Without Intraperitoneal Chemohyperthermia in Treating Patients Undergoing Surgery for Peritoneal Carcinomatosis From Colorectal Cancer
Recruitment status was Recruiting
RATIONALE: Drugs used in chemotherapy, such as leucovorin, fluorouracil, and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether systemic chemotherapy is more effective with or without intraperitoneal chemohyperthermia in treating patients with peritoneal carcinomatosis from colorectal cancer.
PURPOSE: This randomized phase III trial is studying systemic chemotherapy to see how well it works compared with or without intraperitoneal chemohyperthermia in treating patients undergoing surgery for peritoneal carcinomatosis from colorectal cancer.
Primary Peritoneal Cavity Cancer
Drug: leucovorin calcium
Procedure: hyperthermia treatment
|Study Design:||Allocation: Randomized
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- Overall survival [ Designated as safety issue: No ]
- Recurrence-free survival [ Designated as safety issue: No ]
- Toxicity by NCI CTCAE v.3.0 [ Designated as safety issue: Yes ]
- Morbidity from surgical complications (abdominal, extra-abdominal, aplasia) [ Designated as safety issue: Yes ]
|Study Start Date:||February 2008|
Experimental: Arm I
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.
Given IVDrug: leucovorin calcium
Given IVDrug: oxaliplatin
Given during surgeryProcedure: hyperthermia treatment
Given intraperitoneally during surgery
Experimental: 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).
Given IVDrug: leucovorin calcium
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00769405
|Centre Paul Papin||Recruiting|
|Angers, France, 49036|
|Contact: Contact Person 33-2-4135-2700|
|Louis Mourier Hospital||Recruiting|
|Colombes Cedex, France, 92701|
|Contact: Contact Person 33-1- 4760-6162|
|Hopital Du Bocage||Recruiting|
|Dijon, France, 21034|
|Contact: Contact Person 33-3-8029-3031|
|CHU de Grenoble - Hopital de la Tronche||Recruiting|
|Grenoble, France, 38043|
|Contact: Contact Person 33-4-7676-5537|
|Centre Leon Berard||Recruiting|
|Lyon, France, 69373|
|Contact: Contact Person 33-4-78-78-26-45|
|Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle||Recruiting|
|Montpellier, France, 34298|
|Contact: Contact Person 33-4-6731-6015 firstname.lastname@example.org|
|Centre Regional Rene Gauducheau||Recruiting|
|Nantes-Saint Herblain, France, 44805|
|Contact: Contact Person 33-2-40-479-959|
|Hopital de l'Archet CHU de Nice||Recruiting|
|Nice, France, F-06202|
|Contact: Contact Person 33-49-203-9267|
|Paris, France, 75010|
|Contact: Contact Person 33-549-956-565|
|Paris, France, 75970|
|Contact: Contact Person 33-1-4030-7000|
|Centre Hospitalier Lyon Sud||Recruiting|
|Pierre Benite, France, 69495|
|Contact: Contact Person 33-4-78-86-11-58|
|Institut Jean Godinot||Recruiting|
|Reims, France, 51056|
|Contact: Contact Person 33-03-2650-4444|
|Hopital Universitaire Hautepierre||Recruiting|
|Strasbourg, France, 67098|
|Contact: Contact Person 33-388-127-682|
|Centre Hospitalier Regional de Purpan||Recruiting|
|Toulouse, France, 31059|
|Contact: Contact Person 33-5-61-491-133|
|Centre Alexis Vautrin||Recruiting|
|Vandoeuvre-les-Nancy, France, 54511|
|Contact: Contact Person 33-3-8359-8400|
|Institut Gustave Roussy||Recruiting|
|Villejuif, France, F-94805|
|Contact: Contact Person 33-1-4211-4339|
|Principal Investigator:||Francois Quenet, MD||Centre Val d'Aurelle - Paul Lamarque|