Systemic Chemotherapy With or Without Intraperitoneal Chemohyperthermia in Treating Patients Undergoing Surgery for Peritoneal Carcinomatosis From Colorectal Cancer

Phase 3

Completed

• Conditions: Colorectal Cancer; Primary Peritoneal Cavity Cancer
• Interventions: Drug: fluorouracil; Drug: leucovorin calcium; Drug: oxaliplatin; Procedure: hyperthermia treatment

• Registration Number: NCT00769405
• Lead Sponsor: UNICANCER

Brief Summary

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.

Detailed Description

OBJECTIVES:

Primary

* Compare overall survival of patients with peritoneal carcinoma of colorectal origin undergoing complete surgical resection and receiving systemic chemotherapy with versus without intraperitoneal chemohyperthermia.

Secondary

* 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 Timeline

• Study Start: 2008-02
• Study First Submitted: 2008-10-08
• Study First Submitted QC: 2008-10-08
• Study First Posted: 2008-10-09
• Primary Completion: 2015-12
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-29
• Last Update Posted: 2016-08-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 264

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm I	leucovorin calcium	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.
Arm II	leucovorin calcium	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).
Arm I	hyperthermia treatment	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.
Arm I	fluorouracil	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.
Arm II	fluorouracil	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).
Arm I	oxaliplatin	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.

Primary Outcome Measures

Name	Time	Method
Overall survival	until 3 years

Secondary Outcome Measures

Name	Time	Method
Recurrence-free survival	until 3 years
Morbidity from surgical complications (abdominal, extra-abdominal, aplasia)	until 2 months after surgery
Toxicity by NCI CTCAE v.3.0	until 5 years after surgery

Trial Locations

Locations (20)

Centre Leon Berard; 🇫🇷 Lyon, France

Institut Curie; 🇫🇷 Paris, France

Hopital de l'Archet CHU de Nice; 🇫🇷 Nice, France

Hopital Lariboisiere; 🇫🇷 Paris, France

Hopital Tenon; 🇫🇷 Paris, France

Centre Alexis Vautrin; 🇫🇷 Vandoeuvre-les-Nancy, France

Centre Hospitalier Regional de Purpan; 🇫🇷 Toulouse, France

Institut Gustave Roussy; 🇫🇷 Villejuif, France

Centre Hospitalier Lyon Sud; 🇫🇷 Pierre Benite, France

Institut Jean Godinot; 🇫🇷 Reims, France

Hôpital Lariboisière; 🇫🇷 Paris, France

Hopital Universitaire Hautepierre; 🇫🇷 Strasbourg, France

CHU Estaing; 🇫🇷 Clermont Ferrand, France

Centre Paul Papin; 🇫🇷 Angers, France

Hôpital Antoine Béclère; 🇫🇷 Clamart, France

Louis Mourier Hospital; 🇫🇷 Colombes Cedex, France

Hopital Du Bocage; 🇫🇷 Dijon, France

CHU de Grenoble - Hopital de la Tronche; 🇫🇷 Grenoble, France

Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle; 🇫🇷 Montpellier, France

Centre Regional Rene Gauducheau; 🇫🇷 Nantes-Saint Herblain, France