Cytoreduction and Intraperitoneal Chemotherapy Versus Systemic Chemotherapy in Colorectal Peritoneal Carcinomatosis

PHASE3CompletedINTERVENTIONAL
Enrollment

49

Participants

Timeline

Start Date

June 30, 2003

Primary Completion Date

December 31, 2010

Study Completion Date

January 31, 2012

Conditions
Colorectal Peritoneal Carcinomatosis
Interventions
DRUG

Systemic chemotherapy alone (oxaliplatin, 5-fluorouracil, isovorin)

Oxaliplatin 100 mg/ m2 as a 2 h iv infusion + 5-fluorouracil 400 mg/ m2 iv bolus + Isovorin 100 mg/ m2 as a 2 h infusion followed by 5-fluorouracil 2400 mg/ m2 as a 46 h infusion. Each cycle is given every other week until 12 cycles have been administered.

PROCEDURE

Cytoreductive surgery (CRS) plus postoperative intraperitoneal chemotherapy (5-fluorouracil, isovorin)

Cytoreductive surgery has the goal of completely resecting all visible tumor tissue in the abdomen. Sequential postoperative intraperitoneal chemotherapy has the purpose of an adjuvant treatment to eradicate microscopic residual tumor and prevent recurrences in the abdomen. The chemotherapy regimen consisted of intraperitoneal 5-fluorouracil 550 mg/ m2 and intravenous isovorin 30 mg/ m2 day 1-6 med cycles every 4-6 weeks. Six cycles were planned.

Trial Locations (1)

SE-751 85

Akademiska Sjukhuset (Uppsala University Hospital), Uppsala

All Listed Sponsors
lead

Uppsala University

OTHER

NCT01524094 - Cytoreduction and Intraperitoneal Chemotherapy Versus Systemic Chemotherapy in Colorectal Peritoneal Carcinomatosis | Biotech Hunter | Biotech Hunter