NCT00704639

Chemoradiation Treatment for Head and Neck Cancer

A Phase II Study of Cetuximab, Carboplatin and Radiotherapy for Locally Advanced Head and Neck Squamous Cell Carcinoma

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Trans Tasman Radiation Oncology Group · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase II study of cetuximab, carboplatin and radiotherapy (RT) in patients with Locally Advanced Head and Neck Carcinomas (LAHNC) who are unfit for cisplatin. The aim of this study is to show the feasibility and safety profile of the combination of cetuximab, carboplatin and RT in treatment of patients with LAHNC.

Detailed description

Secondary objectives are to estimate failure free survival (FFS) and overall survival, to evaluate the time to local and regional failure and to determine the site of first failure (characterised as local, regional, distant or combinations). Acute and late treatment toxicities will also be evaluated.

Conditions

• Head and Neck Cancer

Interventions

Type	Name	Description
DRUG	Cetuximab	Patients will receive weekly intravenous cetuximab (initial dose 400mg/m2 in the week prior to commencing radiotherapy, then weekly 250mg/m2)for the duration of the radiotherapy
DRUG	Carboplatin	Weekly intravenous carboplatin (AUC 2) for the duration of the RT
RADIATION	Radiotherapy	The radiotherapy schedule will be the "infield boost" (IFB) regimen, that is 66 Gy in 35 fractions over 5 weeks: daily for 3 weeks, then twice daily for 2 weeks (or 70 Gy in 35 fractions over 7 weeks for a specific subgroup of patients where IFB is not recommended).

Timeline

• Start date: 2008-04-01
• Primary completion: 2014-12-01
• Completion: 2015-12-01
• First posted: 2008-06-25
• Last updated: 2017-07-12

Locations

1 site across 1 country: Australia