Evaluation of Bevacizumab in Combination With First-Line Chemotherapy in Patients Aged 75 Years of Older With Metastatic Colorectal Adenocarcinoma (Prodige20)

Sponsor
Centre Hospitalier Universitaire Dijon
Study ID
NCT01900717
Phase
PHASE2
Status
Completed

Conditions

  • Metastatic Colorectal Adenocarcinoma

Eligibility Criteria

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

Interventions

Study Details

To evaluate tolerance to and efficacy of bevacizumab in the treatment of MCRC in elderly patients, we propose a phase II randomised study comparing a chemotherapy + bevacizumab arm with a chemotherapy alone arm in the first-line treatment of MCRC in patients aged 75 years and older. This study is destined to continue as a phase III trial if both arms meet the selection criteria to show or not the benefits of treatment with bevacizumab combined with chemotherapy.

Key Dates

First listed
Jul 16, 2013
Start date
Jul 31, 2011
Status verified
Dec 2018
Primary completion
May 31, 2015
Completion
Mar 31, 2016

Study Design

Enrollment
102 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Active Comparator: chimiotherapy alone
    * LV5FU2 simplified, * 5-fluorouracil/leucovorin with oxaliplatin 4 (FOLFOX) simplified, * fluorouracil, leucovorin, and irinotecan(FOLFIRI) modified.
  • Experimental: chemiotherapy + bevacizumab 5 mg/kg/ 2 weeks
    * LV5FU2 simplified, * FOLFOX 4 simplified, * FOLFIRI modified. * Bevacizumab 5 mg/kg/ 2 weeks

Primary Outcome Measure

Initial examination [ Time Frame: 21 days before the first course of treatment ]

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