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Optimal Maintenance Therapy With Bevacizumab After Induction in Metastatic Colorectal Cancer (CRC)

NCT00973609 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 853

Last updated 2015-09-01

No results posted yet for this study

Summary

Investigating the efficacy of maintenance and reinduction treatment or no treatment and watchful waiting in subjects with inoperable or irresectable and non-progressive metastatic colorectal cancer after first line induction treatment for 24 weeks with a fluoropyrimidine-, oxaliplatin- and bevacizumab-based chemotherapy.

The maintenance treatment with capecitabine or 5-FU/folinic acid and bevacizumab will be compared with a maintenance treatment with bevacizumab alone or no maintenance treatment. Reinduction treatment will be done in case of progression.

Conditions

  • Colorectal Neoplasms

Interventions

DRUG

5-Fluorouracil, Folic acid, Capecitabine; Bevacizumab

Induction (and reinduction) treatment regimen for 24 weeks: Fluoropyrimidine, oxaliplatin and bevacizumab. Following induction treatment regimen (for maintenance treatment): No maintenance treatment.

DRUG

5-Fluorouracil, Folic acid, Capecitabine; Bevacizumab

Induction (and reinduction) treatment regimen for 24 weeks: Fluoropyrimidine, oxaliplatin and bevacizumab. Following induction treatment regimen (for maintenance treatment): Fluoropyrimidine + Bevacizumab.

DRUG

5-Fluorouracil, Folic acid, Capecitabine; Bevacizumab

Induction (and reinduction) treatment regimen for 24 weeks: Fluoropyrimidine, oxaliplatin and bevacizumab. Following induction treatment regimen (for maintenance treatment): Bevacizumab monotherapy.

Sponsors & Collaborators

  • Roche Pharma AG

    collaborator INDUSTRY

  • AIO-Studien-gGmbH

    lead OTHER

Principal Investigators

  • Susanna Hegewisch-Becker, Prof. Dr. · Onkologische Schwerpunktpraxis Eppendorf 20249 Hamburg Germany

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-08-31
Primary Completion
2014-12-31
Completion
2015-08-31

Countries

  • Germany

Study Locations

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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 NCT00973609 on ClinicalTrials.gov