Systemic Chemotherapy With or Without Intraperitoneal Chemohyperthermia in Treating Patients Undergoing Surgery for Peritoneal Carcinomatosis From Colorectal Cancer
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|ClinicalTrials.gov Identifier: NCT00769405|
Recruitment Status : Completed
First Posted : October 9, 2008
Last Update Posted : August 30, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer Primary Peritoneal Cavity Cancer||Drug: fluorouracil Drug: leucovorin calcium Drug: oxaliplatin Procedure: hyperthermia treatment||Phase 3|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||264 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||February 2008|
|Actual Primary Completion Date :||December 2015|
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.
Drug: leucovorin calcium
Given during surgery
Procedure: 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).
Drug: leucovorin calcium
- Overall survival [ Time Frame: until 3 years ]
- Recurrence-free survival [ Time Frame: until 3 years ]
- Toxicity by NCI CTCAE v.3.0 [ Time Frame: until 5 years after surgery ]
- Morbidity from surgical complications (abdominal, extra-abdominal, aplasia) [ Time Frame: until 2 months after surgery ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00769405
|Centre Paul Papin|
|Angers, France, 49036|
|Hôpital Antoine Béclère|
|Clamart, France, 92141|
|Clermont Ferrand, France, 63003|
|Louis Mourier Hospital|
|Colombes Cedex, France, 92701|
|Hopital Du Bocage|
|Dijon, France, 21034|
|CHU de Grenoble - Hopital de la Tronche|
|Grenoble, France, 38043|
|Centre Leon Berard|
|Lyon, France, 69373|
|Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle|
|Montpellier, France, 34298|
|Centre Regional Rene Gauducheau|
|Nantes-Saint Herblain, France, 44805|
|Hopital de l'Archet CHU de Nice|
|Nice, France, F-06202|
|Paris, France, 75005|
|Paris, France, 75010|
|Paris, France, 75010|
|Paris, France, 75970|
|Centre Hospitalier Lyon Sud|
|Pierre Benite, France, 69495|
|Institut Jean Godinot|
|Reims, France, 51056|
|Hopital Universitaire Hautepierre|
|Strasbourg, France, 67098|
|Centre Hospitalier Regional de Purpan|
|Toulouse, France, 31059|
|Centre Alexis Vautrin|
|Vandoeuvre-les-Nancy, France, 54511|
|Institut Gustave Roussy|
|Villejuif, France, F-94805|
|Principal Investigator:||Francois Quenet, MD||Institut du Cancer de Montpellier - Val d'Aurelle|