A Phase II Study In Patients With Advanced Head And Neck Cancer Of Standard Chemoradiation And Add-On Cetuximab

Phase 2

Completed

• Conditions: Oropharyngeal Cancer; Hypopharyngeal Cancer; Laryngeal Cancer
• Interventions: Drug: Cetuximab

• Registration Number: NCT01435252
• Lead Sponsor: University of Zurich

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study First Submitted: 2011-07-26
• Study First Submitted QC: 2011-09-15
• Study First Posted: 2011-09-16
• Study Start: 2011-09-19
• Primary Completion: 2017-10-25
• Study Completion: 2017-10-25
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-02
• Last Update Posted: 2017-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm A	Cetuximab	Patients will be treated with chemoradiation in combination with concurrent cetuximab. Two weeks after end of chemoradiation the consolidation phase will start and patients will receive biweekly consolidation cetuximab, maximally 6 infusions over 12 weeks.
Arm B	Cetuximab	Patients will be treated with chemoradiation in combination with concurrent cetuximab.

Primary Outcome Measures

Name	Time	Method
Locoregional tumor control	2 years

Secondary Outcome Measures

Name	Time	Method
Progression free survival (PFS)	2 years
Biological surrogate markers	2 years
Safety and tolerability	2 years
Metastasis rate	2 years
Metastasis free survival (MFS)	2 years
Overall survival (OS)	2 years

Trial Locations

Locations (1)

University Hospital; 🇨🇭 Zurich, Switzerland