NCT03340896

Trial of Laryngeal Preservation Comparing Induced CT Followed by RT vs CT Concomitant to RT

Phase III Trial of Laryngeal Preservation Comparing Induction Chemotherapy With Cisplatin, 5-fluorouracil and Docetaxel (TPF) Followed by Radiotherapy and Concomitant Administration of Radiotherapy With Cisplatin

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 256 (actual)
• Sponsor: Groupe Oncologie Radiotherapie Tete et Cou · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Head and Neck Squamous Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Docetaxel	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)
DRUG	Cisplatin	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.
DRUG	Fluorouracil	5-FU, 750 mg / m² / day administered in continuous infusion from D1 to D5 (or 120 hours)
RADIATION	radiotherapy	Radiotherapy : 70Gy (2Gy/day) for 7 weeks.

Timeline

• Start date: 2015-06-25
• Primary completion: 2028-10-01
• Completion: 2028-11-01
• First posted: 2017-11-14
• Last updated: 2025-09-02

Locations

1 site across 1 country: France