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

NCT03340896 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 256

Last updated 2025-09-02

No results posted yet for this study

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.

Conditions

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.

Sponsors & Collaborators

  • Groupe Oncologie Radiotherapie Tete et Cou

    lead OTHER

Principal Investigators

  • Yoann POINTREAU, Dr · Centre Jean Bernard

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-25
Primary Completion
2028-10-31
Completion
2028-11-30

Countries

  • France

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03340896 on ClinicalTrials.gov