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

Sponsor
Ludwig-Maximilians - University of Munich
Study ID
NCT01249638
Phase
PHASE3
Status
Unknown

Conditions

  • Colorectal Cancer Metastatic

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Capecitabine — DRUG
    Capecitabine:2 x 1250 mg/m2 day 1-14 followed by 1 week pause q day 21
  • Bevacizumab — DRUG
    Bevacizumab: 7.5 mg/kg day 1 q day 21
  • Capecitabine — DRUG
    Capecitabine: 2 x 800mg/m2 day 1-14 followed by 1 week pause q day 21
  • Irinotecan — DRUG
    Irinotecan: 200 mg/m2 day 1 , q day 21
  • Bevacizumab — DRUG
    Bevacizumab: 7.5 mg/kg day 1, q day 21

Study Details

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.

Key Dates

Start date
Dec 31, 2010
Status verified
Nov 2010
Primary completion
Dec 31, 2013
Completion
Dec 31, 2016

Study Design

Enrollment
516 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Cap+Bev until PD followed by CAPIRI +Bev
    Capecitabine + Bevacizumab In case of Progression Escalation to: Capecitabine + Irinotecan + Bevacizumab
  • Active Comparator: Capiri + Bev
    Capecitabine + Irinotecan + Bevacizumab

Primary Outcome Measure

TFS [ Time Frame: 9 months ]

Central Contacts

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