Modulation of Adjuvant 5-FU by Folinic Acid and Interferon-alpha in Colon Cancer

PHASE3CompletedINTERVENTIONAL
Enrollment

796

Participants

Timeline

Start Date

July 31, 1992

Primary Completion Date

July 31, 2009

Study Completion Date

July 31, 2009

Conditions
Rectal Cancer
Interventions
DRUG

Folinic Acid, interferon-alpha

5-FU, 450 mg/m² i.v. for 60 min, weekly for 52 weeks postoperatively Folinic acid, 200 mg/m² i.v. 10 min, weekly for 52 weeks postoperatively 6x10 (high6) I.U. as subcutaneous self injection 3x weekly. Training of self injection was initiated on day 28 (duration until week 52)

Trial Locations (1)

89075

Department of General, Visceral, and Transplantation Surgery, University of Ulm, Ulm

All Listed Sponsors
collaborator

Medac GmbH (Hamburg, Germany)

UNKNOWN

collaborator

Roche (Grenzach-Wyhlen, Germany)

UNKNOWN

lead

University of Ulm

OTHER

NCT01060501 - Modulation of Adjuvant 5-FU by Folinic Acid and Interferon-alpha in Colon Cancer | Biotech Hunter | Biotech Hunter