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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00769405
First received: October 8, 2008
Last updated: April 19, 2011
Last verified: September 2009
History of Changes
  Purpose

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 Intervention Phase
Colorectal Cancer
Primary Peritoneal Cavity Cancer
 Drug: fluorouracil
Drug: leucovorin calcium
Drug: oxaliplatin
Procedure: hyperthermia treatment
 Phase 3

Study Type: Interventional
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Overall survival [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 264
Study Start Date: February 2008
Arms Assigned Interventions
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: fluorouracil
Given IV
Drug: leucovorin calcium
Given IV
Drug: oxaliplatin
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: fluorouracil
Given IV
Drug: leucovorin calcium
Given IV

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00769405

Locations
France
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     francois.quenet@valdorel.fnclcc.fr    
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        
Hopital Lariboisiere Recruiting
Paris, France, 75010
Contact: Contact Person     33-549-956-565        
Hopital Tenon Recruiting
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        
Sponsors and Collaborators
UNICANCER
Investigators
Principal Investigator: Francois Quenet, MD Centre Val d'Aurelle - Paul Lamarque
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00769405     History of Changes
Other Study ID Numbers: CDR0000595024, FRE-FNCLCC-ACCORD-15/0608, EUDRACT-2006-006175-20, EU-20847
Study First Received: October 8, 2008
Last Updated: April 19, 2011
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
recurrent colon cancer
stage IV colon cancer
recurrent rectal cancer
stage IV rectal cancer
peritoneal carcinomatosis

Additional relevant MeSH terms:
Peritoneal Diseases
Colorectal Neoplasms
Peritoneal Neoplasms
Carcinoma
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Abdominal Neoplasms
 Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Fluorouracil
Oxaliplatin
Leucovorin
Levoleucovorin
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 23, 2013