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
18 Years
70 Years
Both
Colorectal Cancer, Primary Peritoneal Cavity Cancer
Trial Information
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
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Overall survival
Safety Issue:
No
Principal Investigator
Francois Quenet, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Centre Val d'Aurelle - Paul Lamarque
Authority:
Unspecified
Study ID:
CDR0000595024
NCT ID:
NCT00769405
Start Date:
February 2008
Completion Date:
Related Keywords:
- Colorectal Cancer
- Primary Peritoneal Cavity Cancer
- recurrent colon cancer
- stage IV colon cancer
- recurrent rectal cancer
- stage IV rectal cancer
- peritoneal carcinomatosis
- Colorectal Neoplasms
- Peritoneal Neoplasms
- Carcinoma
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