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

Head and Neck Squamous Cell Carcinoma Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

  • Head and Neck Squamous Cell Carcinoma
  • Squamous Cell Carcinoma of Head and Neck
Clinical Trial Details
NCT number NCT03340896
Study type Interventional
Source Groupe Oncologie Radiotherapie Tete et Cou
Contact
Status Active, not recruiting
Phase Phase 3
Start date June 25, 2015
Completion date November 2028
View Details
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