Status:

COMPLETED

Avastin and Chemotherapy Followed by a KRAS Stratified Randomization to Maintenance Treatment for First Line Treatment of Metastatic Colorectal Cancer.

Lead Sponsor:

Lund University Hospital

Collaborating Sponsors:

Hoffmann-La Roche

Conditions:

Colorectal Cancer

Eligibility:

All Genders

18+ years

Phase:

PHASE3

Brief Summary

Patients with metastatic colorectal cancer will be treated with chemotherapy according to investigators choice. In addition to chemotherapy treatment, treatment with bevacizumab will be given concomit...

Eligibility Criteria

Inclusion

  • Untreated metastatic colorectal carcinoma
  • Age 18 yrs or over
  • Measurable disease according to Response Evaluation Criteria in solid Tumors (RECIST criteria)
  • ECOG performance status 0 or 1
  • Life expectancy more than 3 months
  • Adequate haematological, renal and liver function
  • Tumor tissue available for determination of KRAS mutational status
  • Blood sample and paraffin embedded tumor tissue for translational research

Exclusion

  • Adjuvant therapy within 6 months
  • CNS metastases
  • Clinically significant atherosclerotic vascular disease

Key Trial Info

Start Date :

October 1 2010

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 1 2013

Estimated Enrollment :

233 Patients enrolled

Trial Details

Trial ID

NCT01229813

Start Date

October 1 2010

End Date

December 1 2013

Last Update

April 13 2015

Active Locations (12)

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Page 1 of 3 (12 locations)

1

University Hospital

Odense, Denmark

2

County Hospital Ryhov

Jönköping, Sweden

3

County Hospital

Kalmar, Sweden

4

Central Hospital

Karlstad, Sweden

Avastin and Chemotherapy Followed by a KRAS Stratified Randomization to Maintenance Treatment for First Line Treatment of Metastatic Colorectal Cancer. | DecenTrialz