A Phase II, Randomized, Open-Label, Single Center Study In Patients With Advanced Head And Neck Cancer To Investigate Efficacy And Safety Of Standard Chemoradiation And Add-On Concurrent Cetuximab ± Consolidation Cetuximab
This clinical study translates our preclinical findings that concurrent and consolidation
cetuximab improves efficacy of RT into the clinic. It is a phase II, randomized, open-label,
single center study in patients with locoregionally advanced stage III-IV and/or total gross
tumor volume (tGTV) > 70cc head and neck cancer. This study population is at high risk for
locoregional recurrence after chemoradiation alone. Tumor stages to be included are T3-4 Nx,
Tx N2b-N3 (N2b only if ≥ 3 ipsilateral nodes involved) M0 and/or tGTV >70 cc (any T, any N,
M0) squamous cell cancers of the head and neck (HNSCC). All patients will receive in, the so
called 'Induction Phase' standard chemoradiation (RT up to 70 Gy in combination with weekly
CDDP 40 mg/m2) and add-on concurrent cetuximab (loading Dose 400 mg/m2, concurrent dose 250
mg/m2 weekly). The patients are randomized to either add-on consolidation cetuximab (500
mg/m2 biweekly x 6 over 12 weeks) (Arm A) or no further treatment (Arm B). Randomization
will take place after Induction Phase. The total number of patients to be included into the
study is 60 (30 patients per arm). Up to 6 patients may be replaced in case of early drop
out to reach that aim.
The sample size of 60 patients is considered to be sufficient to collect first information
on clinical efficacy and the possible impact of various biomarkers on clinical endpoints. If
the results of this study will demonstrate that the novel treatment regimen is safe and
efficacious, a randomized multicenter phase III study will follow.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Locoregional tumor control
2 years
No
Oliver Riesterer, Oberarzt
Principal Investigator
University Hospital Zurich, Division of Radiation Oncology
Switzerland: Swissmedic
Add-On cetuximab
NCT01435252
September 2011
November 2015
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