Status:
COMPLETED
Systemic Chemotherapy With or Without Intraperitoneal Chemohyperthermia in Treating Patients Undergoing Surgery for Peritoneal Carcinomatosis From Colorectal Cancer
Lead Sponsor:
UNICANCER
Conditions:
Colorectal Cancer
Primary Peritoneal Cavity Cancer
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
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...
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 witho...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
264 Patients enrolled
Trial Details
Trial ID
NCT00769405
Start Date
February 1 2008
Last Update
August 30 2016
Active Locations (20)
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1
Centre Paul Papin
Angers, France, 49036
2
Hôpital Antoine Béclère
Clamart, France, 92141
3
CHU Estaing
Clermont-Ferrand, France, 63003
4
Louis Mourier Hospital
Colombes, France, 92701