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ACTIVE NOT RECRUITING
NCT03340896
PHASE3

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

Sponsor: Groupe Oncologie Radiotherapie Tete et Cou

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

256

Start Date

2015-06-25

Completion Date

2028-11

Last Updated

2025-09-02

Healthy Volunteers

No

Interventions

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.

Locations (1)

Centre Jean Bernard

Le Mans, France