Pilot / Phase III Randomized Trial Comparing Standard Systemic Therapy to Cytoreduction + Hyperthermic Intraperitoneal Mitomycin C + Standard Systemic Therapy in Patients With Limited Peritoneal Dissemination of Colon Adenocarcinoma

NCT01167725 Phase 3 TERMINATED

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

Details

Lead sponsor	Alliance for Clinical Trials in Oncology
Phase	Phase 3
Status	TERMINATED
Enrolment	340
Start date	2010-08
Completion	2012-01

Conditions

• Colorectal Cancer

Interventions

• bevacizumab
• cetuximab
• FOLFIRI regimen
• FOLFOX regimen
• capecitabine
• fluorouracil
• irinotecan hydrochloride
• leucovorin calcium
• mitomycin C
• oxaliplatin

Primary outcomes

• Overall survival (OS)

Countries

United States