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About
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Heating mitomycin C to several degrees above normal body temperature and infusing it into the area around the tumor may kill more tumor cells. Giving mitomycin C after surgery may kill any remaining tumor cells. It is not yet known whether standard therapy is more effective with or without surgery followed by mitomycin C.
PURPOSE: This randomized phase III trial is studying standard therapy with or without surgery and mitomycin C in treating patients with advanced limited peritoneal dissemination of colon cancer
Full description
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study. Patients are stratified according to presentation (synchronous vs metachronous carcinomatosis), ECOG performance status (0 vs 1), disease volume (measurable vs non-measurable), prior first-line therapy for advanced disease (chemo-naïve vs prior first-line therapy), planned chemotherapy (oxaliplatin vs irinotecan vs fluorouracil/leucovorin calcium vs capecitabine), and planned biologic therapy (bevacizumab vs cetuximab vs none). Patients are randomized to 1 of 2 treatment arms.
NOTE: *For patients with KRAS wild-type tumors.
Blood and tissue samples may be collected from patients for correlative studies.
Patients complete SF-36 Health Survey; Functional Assessment of Cancer Therapy-Colorectal (FACT-C); Feeling Sad, Down, or Depressed (CES-D); and a Brief Pain Inventory quality-of-life questionnaires at baseline and then periodically during study.
After completion of study therapy, patients are followed up periodically for 5 years.
Enrollment
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Inclusion and exclusion criteria
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed colon adenocarcinoma meeting the following criteria:
Disease amenable to complete cytoreduction surgery as indicated by:
PATIENT CHARACTERISTICS:
ECOG performance status 0-1
ANC > 1,200/mm³
WBC > 4,000/mm³
Platelet count 150,000/mm³
INR ≤ 1.5
Total serum bilirubin ≤ 1.5 mg/dL (> 1.5 mg/dL for patients with Gilbert syndrome)
Alkaline phosphatase < 2.5 times upper limit of normal (ULN)
AST < 1.5 times ULN
Serum creatinine normal
BUN normal
Not pregnant or nursing
Fertile patients must use effective contraception
No history of severe congestive heart failure or severe pulmonary disease
No acute myocardial infarction within the past 6 months
No significant history of a medical problem or co-morbidity (e.g., severe congestive heart failure or active ischemic heart disease) that would preclude a major abdominal operation
No concurrent second malignancy requiring systemic therapy
No psychiatric or addictive disorders, or other conditions that would preclude the patient from meeting the study requirements
PRIOR CONCURRENT THERAPY:
See Disease Characteristics
No prior second-line systemic treatment for metastatic colon adenocarcinoma
340 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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