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

NCT01060501 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 796

Last updated 2010-02-02

No results posted yet for this study

Summary

The primary objective was to improve adjuvant 5-FU chemoradiotherapy in resectable rectal cancer. The investigators hypothesis was that modulation of 5-FU by addition of either FA or INF-alpha may increase overall survival.

Conditions

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)

Sponsors & Collaborators

  • Medac GmbH (Hamburg, Germany)

    collaborator UNKNOWN

  • Roche (Grenzach-Wyhlen, Germany)

    collaborator UNKNOWN

  • University of Ulm

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1992-07-31
Primary Completion
2009-07-31
Completion
2009-07-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01060501 on ClinicalTrials.gov