An Open Label Randomized, Multi-Centre Phase III Trial of TPF Chemotherapy Plus Concomitant Treatment With Cisplatin and Conventional Radiotherapy Versus TPF Chemotherapy Plus Concomitant Cetuximab and Conventional Radiotherapy in Locally Advanced, Unresectable Head and Neck Cancer.
This study is being sponsored by a cooperative medical group.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
519
3 cycles of: cisplatin: 75 mg/m2, i.v., 1 hour, once daily docetaxel: 75 mg/m2, i.v., 1 hour, once daily 5-fluorouracil: 750 mg/m2, i.v., 24 hours, 5 days Radiotherapy: 70Gy, divided into daily doses of 2 Gray (total days: 35) Cisplatin: 100 mg/m2, i.v., 1 hour, 3 days
3 cycles of: cisplatin: 75 mg/m2, i.v., 1 hour, once daily docetaxel: 75 mg/m2, i.v., 1 hour, once daily 5-fluorouracil: 750 mg/m2, i.v., 24 hours, 5 days Radiotherapy: 70Gy, divided into daily doses of 2 Gray (total days: 35) Cetuximab: 400 mg/m2, i.v, 2 hours, 1 day Cetuximab: 250 mg/m2, i.v, 1 hour, 7 days
Global survival
The time from the start of induction chemotherapy with TPF to death due to any cause or to the last check-up in the case of living patients
Time frame: Up to 89 months
Overall response rate (ORR)
The response rate (CR + PR) measured using the RECIST 1.0 method.
Time frame: Up to 89 months
Progression free-survival (PFS)
Time to progression as the time since the start date of treatment with TPF induction chemotherapy until the time when DP occurred or death occurred due to any cause.
Time frame: Up to 89 months
Time to loco-regional control of disease
As permanent and complete resolution of the disease in terms of its initial site and lymph nodes (T and N). If the disease lasted (regardless of size), the tumor recurred, or a second tumor appeared in the field RT, it will be recorded as a therapeutic failure.
Time frame: Up to 89 months
Satisfaction with treatment. Analysis of QoL in both treatment arms.
EORTC QoL questionnaires: C30 version 3.0 and QLQ-H\&N35 module
Time frame: Up to 89 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Hospital Puerta del Mar
Almería, Almería, Spain
Hospital Germans Trias i Pujol
Badalona, Barcelona, Spain
Hospital Durán i Reynals
Hospitalet de Ll., Barcelona, Spain
Hospital de Manresa
Manresa, Barcelona, Spain
Hospital Mútua de Terrassa
Terrassa, Barcelona, Spain
Hospital Son Dureta
Palma de Mallorca, Mallorca, Spain
Hospital Son Llàtzer
Palma de Mallorca, Mallorca, Spain
Hospital de Sagunto
Sagunto, Valencia, Spain
Hospital general Universitario
Alicante, Spain
Hospital Nuestra Señora de Sonsoles
Ávila, Spain
...and 29 more locations