The purpose of this study is to determine whether the early and continuous addition of bevacizumab for up to 30 months to the standard chemotherapy is more effective than the early and continuous addition of bevacizumab for up to 15 months.
Determination whether the early and continuous addition of bevacizumab for up to 30 months to the standard chemotherapy is more effective than the early and continuous addition of bevacizumab for up to 15 months
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
927
15 mg/kg, iv on day 1 every 3 weeks up to and including cycle 22 vs cycle 44
175 mg/m², iv on day 1 every 3 weeks for 6 cycles
AUC 5, iv on day 1 every 3 weeks for 6 cycles
Progression Free Survival (PFS)
Time frame: every 12 weeks until progression or up to 30 months, thereafter every 6 months
Objective response rate (ORR)
Time frame: every 12 weeks until progression or up to 30 months, thereafter every 6 months
Overall survival (OS)
Time frame: every 3 weeks, 31 months after start of treatment, thereafter every 6 months
Health related Quality of life (QoL)
Time frame: baseline, then every 12 weeks until progression, 31 months after start of treatment or if applicable 4 weeks after last dose of bevacizumab (whichever occurs later)
Safety and tolerability, i.e. type, frequency, severity and duration of adverse reactions
Time frame: every 3 weeks, 31 months after start of treatment or if applicable 4 weeks after last dose of bevacizumab (whichever occurs later)
Translational Research - Tumor Tissue Block
may be obtained at any time during therapy, preferably at cycle 1 or at a subsequent visit
Time frame: Assessment at end of study planned
Translational Research - Complementary and Alternative Treatment Questionnaires
Time frame: baseline, 6 months and 12 months after start of treatment, if required at timepoint of treatment termination
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
before randomization
Unnamed facility
Aalborg, Denmark
Unnamed facility
Copenhagen, Denmark
Unnamed facility
Herlev, Denmark
Unnamed facility
Kuopio, Finland
Unnamed facility
Oulu, Finland
Unnamed facility
Tampere, Finland
Unnamed facility
Turku, Finland
Unnamed facility
Angers, France
Unnamed facility
Besançon, France
Unnamed facility
Blois, France
...and 121 more locations