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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
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
Weekly intravenous carboplatin (AUC 2) for the duration of the RT
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).
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia
Safety and Feasibility
Time frame: An initial 6 patients will be treated. Once all these patients have a 2 week post RT review there will be analysis. If <= 1 patient has a DLT than the treatment is deemed safe.
Failure free survival (FFS)
Time frame: All patients will be followed until the last patient enrolled has a minimum follow up of 2 years post treatment.
Time to local and/or regional failure
Time frame: All patients will be followed until the last patient enrolled has a minimum follow up of 2 years post treatment.
Overall survival
Time frame: All patients will be followed until the last patient enrolled has a minimum follow up of 2 years post treatment.
Site of first failure
Time frame: All patients will be followed until the last patient enrolled has a minimum follow up of 2 years post treatment.
Acute and late treatment toxicities
Time frame: All patients will be followed until the last patient enrolled has a minimum follow up of 2 years post treatment.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.