The aim of the trial is to evaluate the clinical benefit (efficacy, safety, preservation of autonomy) of cetuximab-carboplatin-5FU combination as first line treatment of recurrent or metastatic head and neck squamous cell carcinoma in patients over 70 years without frailty (after geriatric assessment).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
85
6 cycles (1 cycle = 21 days) of: carboplatin AUC 5, 5FU D1-4 1000mg/m²/d, every 21 days cetuximab weekly (400 mg/m² the first week of treatment and then 250 mg/m²/w) Maintenance by cetuximab 500 mg/m² every 2 weeks until progression or toxicity
Hôpital de la Dracénie
Draguignan, France
Institut Gustave Roussy
Villejuif, France
Objective response and acute toxicity
Objective tumor response at 12 weeks, safety (no grade 3, 4, 5 toxicities) and preservation of geriatric autonomy (absence of 2 or more points decrease on the Activities of Daily Living (ADL) scale) 1 month after the end of chemotherapy
Time frame: 1 month after the end of chemotherapy
Best objective tumor response
Best objective tumor response during treatment
Time frame: 6 weeks after the end of treatment
Overall survival
Overall survival
Time frame: 1 year after the end of treatment
progression free survival
progression free survival
Time frame: 1 year after the end of treatment
Duration of response under cetuximab maintenance therapy
Duration of response under cetuximab maintenance therapy
Time frame: 1 year after the end of maintenance
Toxicity of cetuximab maintenance therapy
Toxicity of cetuximab maintenance therapy
Time frame: 3 months after the end of maintenance
autonomy
Autonomy assessed by ADL and IADL scales during treatment and until 1 month after the end of treatment
Time frame: 1 month after the end of treatment
Health related quality of life
Quality of life assessed by EORTC QLQ-C30 and QLQ-HN35 questionnaires
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 1 month after the end of chemotherapy