Spots Global Cancer Trial Database for OPAL Study: A Study of Avastin (Bevacizumab) in Combination With FOLFOXIRI in Patients With Previously Untreated Metastatic Colorectal Cancer
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Trial Identification
Brief Title: OPAL Study: A Study of Avastin (Bevacizumab) in Combination With FOLFOXIRI in Patients With Previously Untreated Metastatic Colorectal Cancer
Official Title: An Open Label, Single-arm, Phase II Study to Evaluate the Efficacy and the Feasibility of Bevacizumab (Avastin) Based on a FOLFOXIRI Regimen Until Progression in Patients With Previously Untreated Metastatic Colorectal Carcinoma(OPAL-Study)
Study ID: NCT00940303
Conditions
Study Description
Brief Summary: This single arm study will assess progression-free survival, feasibility of use and safety of Avastin in combination with 5-FU/FA, oxaliplatin and irinotecan (FOLFOXIRI) as first line treatment in patients with metastatic colorectal cancer. Patients will receive up to 12 bi-weekly cycles of Avastin (5mg/kg iv) in combination with this standard neoadjuvant chemotherapy regimen followed by up to 40 bi-weekly cycles with Avastin plus 5-FU/FA. The anticipated time on study treatment is until disease progression, and the target sample size is \<100 individuals.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
, Berlin, , Germany
, Berlin, , Germany
, Bochum, , Germany
, Celle, , Germany
, Celle, , Germany
, Dessau-Roßlau, , Germany
, Freiburg, , Germany
, Fulda, , Germany
, Hamburg, , Germany
, Hamburg, , Germany
, Hannover, , Germany
, Leer, , Germany
, Magdeburg, , Germany
, Magdeburg, , Germany
, Nürnberg, , Germany
, Stade, , Germany
, Villingen-Schwenningen, , Germany
Contact Details
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_DIRECTOR
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