The purpose of this study is to determine the treatment effect of Panitumumab in combination with chemotherapy versus chemotherapy alone as first line therapy for metastatic and/or recurrent squamous cell carcinoma of the head and neck.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
658
Overall Survival
Time from randomization to death
Time frame: Upto 56 months
Overall Response Rate
An objective tumor response of complete or partial response per modified Response Evaluation Criteria in Solid Tumors (RECIST) v1.0 that was confirmed no less than 28 days after the criteria for response were first met. Complete response = disappearance of all target lesions and partial response = ≥30% reduction in lesion size.
Time frame: Every 6 weeks until disease progression, up to 56 months
Duration of Response
Time from the first confirmed objective response of complete or partial response (that is subsequently confirmed at least 28 days later) to disease progression using a modified version of the RECIST v1.0 (see protocol Appendix H).
Time frame: Every 6 weeks until disease progression, up to 56 months
Time to Progression
Time from randomization date to date of disease progression using a modified version of the RECIST 1.0 (see protocol Appendix H)
Time frame: Every 6 weeks until disease progression, up to 56 months
Time to Response
Time from randomization date to the first confirmed objective response of complete or partial response (that is subsequently confirmed at least 28 days later) using a modified version of the RECIST v1.0.
Time frame: Every 6 weeks until disease progression, upto 56 months
Progression Free Survival
Time from randomization date to date of disease progression using a modified version of the RECIST v1.0 or death.
Time frame: Every 6 weeks until disease progression or deaths, upto 56 months
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