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Cap+Bev vs Cap+Iri+Bev 1st-line Therapy in mCRC

NCT01249638 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 516

Last updated 2011-03-14

No results posted yet for this study

Summary

Patient with multiple metastases, not eligible for surgery, might not profit from intensive chemotherapy regimens. Therefore less intensive regimens focusing on survival and disease control may be a better choice for first line treatment. Therefore this study investigates the combination of capecitabine and bevacizumab versus the combination of capecitabine, bevacizumab and irinotecan. In case of progressive disease, the therapy in patients treated with capecitabine and bevacizumab is intensified by adding irinotecan. Primary endpoint is time-of-failure strategy (TFS) comparing both treatment arms.

Conditions

  • Colorectal Cancer Metastatic

Interventions

DRUG

Capecitabine

Capecitabine:2 x 1250 mg/m2 day 1-14 followed by 1 week pause q day 21

DRUG

Bevacizumab

Bevacizumab: 7.5 mg/kg day 1 q day 21

DRUG

Capecitabine

Capecitabine: 2 x 800mg/m2 day 1-14 followed by 1 week pause q day 21

DRUG

Irinotecan

Irinotecan: 200 mg/m2 day 1 , q day 21

DRUG

Bevacizumab

Bevacizumab: 7.5 mg/kg day 1, q day 21

Sponsors & Collaborators

  • Roche Pharma AG

    collaborator INDUSTRY

  • Ludwig-Maximilians - University of Munich

    lead OTHER

Principal Investigators

  • Volker Heinemann, Prof. Dr. med. · University of Munich - Klinikum der Universitaet Muenchen

  • Sebastian Stintzing, Dr. med. · University of Munich - Klinikum der Universitaet Muenchen

  • Clemens Giessen · University of Munich - Klinikum der Universitaet Muenchen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-12-31
Primary Completion
2013-12-31
Completion
2016-12-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Drugs

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 NCT01249638 on ClinicalTrials.gov