The main purpose of this study is to explore and compare the efficacy of Cetuximab (ERBITUX®) added to two concurrent chemoradiotherapy platforms of different intensity in locally advanced head and neck cancer.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
110
250mg/m2(day 1, weekly x 10);
600 mg/m2/day; days 0-5 (120 h total) every other week x 5
500 mg PO BID, days 0-5 every other week x 5
University of Chicago
Chicago, Illinois, United States
Progression Free Survival (PFS)
Kaplan-Meier estimate of PFS at 1 years. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Time frame: 1 years
Progression Free Survival (PFS)
Time from randomization until disease progression or death from any cause. Kaplan-Meier estimate of PFS at 2 years. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Time frame: 2 years
Overall Survival (OS)
Time from randomization until death from any cause. Kaplan-Meier estimate of OS at 2 years.
Time frame: 2 years
Objective Response Rate to Induction
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Time frame: Post-Induction (8 weeks)
Objective Response Rate to CRT
Response to CRT was assessed by determining whether there was evidence of residual disease in the primary site via radiographic and clinical examination.
Time frame: From date of chemoradiotherapy until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 10 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
150 cGy per fraction, days 1-5, every other week x 5 (total duration 10 weeks)
100 mg/m2, week 1 and 4 on day 1 (or 2)
72 Gy/42 F/6 W (3-D or IMRT based). Total duration 7 weeks.
Residual Lymph Node Disease
Response to CRT was also assessed by determining if there was evidence of residual lymph node disease by neck dissection, if warranted by the presence of any radiographically large (\>1.5 cm) or focally abnormal lymph node.
Time frame: Up to 10 weeks