Oropharyngeal Cancer Clinical Trial
Official title:
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
Sixty patients with advanced squamous cell carcinomas of the head and neck will be enrolled
in this study. Patients are treated with standard chemoradiation in combination with
concurrent add-on cetuximab. Subsequently patients are randomized to cetuximab consolidation
therapy (three months, Arm A) versus no consolidation therapy (Arm B). The aim of this study
is to investigate if cetuximab consolidation therapy improves the 2-year locoregional control
rate.
- Trial with medicinal product
- Trial with radiotherapy
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.
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