Adjuvant HIPEC to Prevent Colorectal Peritoneal Metastases in High-risk Patients

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

January 31, 2006

Primary Completion Date

June 30, 2010

Study Completion Date

December 31, 2011

Conditions
Colorectal NeoplasmMetastasis
Interventions
DRUG

adjuvant HIPEC

Closed-abdomen HIPEC with cisplatin (25 mg/m2/l of perfusate) and mitomycin-C (3•3 mg/m2/l of perfusate) at 42•5°C for 60 minutes. Perfusate volume: 4-6 l.

PROCEDURE

surgery

Colon resections for primary tumors were performed according to the oncologic principles of adequate lymph-adenectomy. Complete adhesiolysis, resection of falciform hepatic ligament, greater and lesser omentectomy were performed in all patients to ensure optimal perfusion during the HIPEC. Tumor deposits on visceral and parietal surfaces were surgically removed by formal peritonectomy procedures and/or organ resections, as needed.

All Listed Sponsors
collaborator

Azienda Usl di Bologna

OTHER_GOV

lead

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

OTHER

NCT02575859 - Adjuvant HIPEC to Prevent Colorectal Peritoneal Metastases in High-risk Patients | Biotech Hunter | Biotech Hunter