locally advanced squamous cell carcinoma
Conditions
Brief summary
Rate of patient success at 8 weeks
Detailed description
Overall survival defined by the time between the date of randomization and the date of death from any cause. In the absence of notification of death, survival data will be censored on the date of last news without progression., Progression-free survival defined by the time between the date of randomization and the date of first evidence of progression, the date of death from any cause or the date of last news without progression., Rate of patients in local and/or locoregional control of the disease at week 8 ± 3 days., Rate of patients with larynx preservation. Is considered as total laryngectomy event., Metastasis-free survival defined by the time between the date of randomization and the date of first evidence of metastatic progression, or the date of death, whatever the cause., Toxicity of complementary treatment to induction treatment., Rate of patients who received the entire induction treatment., Rate of patients who received the entire complementary treatment to induction treatment., Hospitalization or extension of hospitalization for toxicity linked to the treatments under study., Quality of life according to the EORTC QLQ-C30 and EORTCH& N35 questionnaires
Interventions
DRUGsolution à diluer pour perfusion
DRUGFluorouracil Accord 50 mg/ml διάλυμα για ένεση/έγχυση
DRUGCisplatin Accord 1 mg/ml Konzentrat zur Herstellung einer Infusionslösung
Sponsors
Groupe Oncologie Radiotherapie Tete Cou
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of patient success at 8 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival defined by the time between the date of randomization and the date of death from any cause. In the absence of notification of death, survival data will be censored on the date of last news without progression., Progression-free survival defined by the time between the date of randomization and the date of first evidence of progression, the date of death from any cause or the date of last news without progression., Rate of patients in local and/or locoregional control of the disease at week 8 ± 3 days., Rate of patients with larynx preservation. Is considered as total laryngectomy event., Metastasis-free survival defined by the time between the date of randomization and the date of first evidence of metastatic progression, or the date of death, whatever the cause., Toxicity of complementary treatment to induction treatment., Rate of patients who received the entire induction treatment., Rate of patients who received the entire complementary treatment to induction treatm | — |
Countries
France
Outcome results
None listed