This is a phase II, randomized, multi-center, open-label, parallel-group study to evaluate the progression-free survival during maintenance therapy. Eligible patients will be treated within a 12-week induction therapy. Those patients achieving CR/PR or SD at 12 weeks and qualifying for maintenance treatment and re-induction treatment with all potential drug components, will be randomized in a ratio of 1:1 to receive chemotherapy plus panitumumab or chemotherapy alone during maintenance. In case of progression, re-induction treatment will be started.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
387
St.-Antonius-Hospital Eschweiler
Eschweiler, Germany
Zentrum für Tumorbiologie und Integrative Medizin, Klinikum Wilhelmshaven
Wilhelmshaven, Germany
Progression-free survival
Progression-free survival during maintenance therapy defined as time from randomization until disease progression or death, whatever occurs first.
Time frame: Until end of follow-up (24 months after randomization)
failure of treatment strategy
Time from randomization until failure (death/ progression) of treatment strategy
Time frame: Until end of follow up (24 months after randomization)
Progression-free survival of re-induction
Progression-free survival during re-induction therapy
Time frame: From start of re-induction therapy until progress or end of follow-up (24 months after randomization)
Objective response after 12 weeks of induction chemotherapy
Objective response after 12 weeks of induction chemotherapy
Time frame: 12 weeks after start of induction chemotherapy
Objective best response during maintenance and re-induction
Objective best response during maintenance and re-induction
Time frame: Start of maintenance- until end of re-inductin therapy (expected average of 8 months)
Overall survival
Overall survival measured from time of randomization and from time of registration
Time frame: Until end of follow-up (24 months after randomization)
Safety
Overall safety
Time frame: Until end of follow-up (24 months after randomization)
Health and skin related Quality of life
Health and skin related Quality of life
Time frame: Until end of follow-up (24 months after randomization)
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