NCT03340896 - Trial of Laryngeal Preservation Comparing Induced CT Followed by RT vs CT Concomitant to RT | Biotech Hunter

Enrollment

256

Participants

Timeline

Start Date

June 25, 2015

Primary Completion Date

October 31, 2028

Study Completion Date

November 30, 2028

Conditions

Head and Neck Squamous Cell Carcinoma

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.

Trial Locations (1)

72000

Centre Jean Bernard, Le Mans

All Listed Sponsors

lead

Groupe Oncologie Radiotherapie Tete et Cou

OTHER