This study compare the survival without laryngeal dysfunction 2 years after the end of treatment, obtained by chemotherapy followed by radiotherapy or chemotherapy with cisplatin administrated during radiotherapy.
In patients with tumors classified as T3 or T4 larynx and hypopharynx, the usually recommended treatment was total laryngectomy.This intervention allows to obtain locoregional disease control in 75% of cases, without laryngectomy TPF arm followed by radiotherapy was validated in a Phase III (GORTEC 2000-01), it will be the standard treatment. The RTOG study concluded that chemotherapy administrated during radiotherapy became a standard of laryngeal preservation. Taking together all these considerations, it is necessary to perform a direct comparison in a randomized trial to further test this hypothesis. Chemotherapy followed by radiotherapy will be the standard arm. It hopes to increase the survival rate from 52% to 65% in the experimental arm.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
256
Docetaxel 75 mg / m² administered on day 1 of each cycle every 3 weeks as an intravenous (IV) infusion of one hour followed by cisplatin 75 mg / m² administered on day 1 hour infusion followed by 5-FU, 750 mg / m² / day administered in continuous infusion from D1 to D5 (or 120 hours)
Cisplatin: 75 mg/m² for experimental arm and 100mg/m² for comparator arm administered on day 1 of each cycle every 3 weeks as an intravenous (IV) infusion.
5-FU, 750 mg / m² / day administered in continuous infusion from D1 to D5 (or 120 hours)
Centre Jean Bernard
Le Mans, France
free survival
Minimum time between randomization and the occurrence of events such as: death, total laryngectomy, tracheotomy.
Time frame: 24 months after treatment initiation
Overall survival
"From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months").
Time frame: 60 months
Progression free survival
"From date of randomization until the date of first documented progression assessed up to 60 months").
Time frame: 60 months
Larynx Preservation
From date of randomization up to 24 months evaluated by dynamic deglutition videoscopy
Time frame: 24 months after treatment initiation
Feasibility of salvage surgery
Assessing the number of recurrences that could be successfully treated with salvage surgery and description of postoperative
Time frame: 60 months after randomization
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Radiotherapy : 70Gy (2Gy/day) for 7 weeks.