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

NCT03340896 | Active Not Recruiting Phase 3 DMC

• 1 other identifier: GORTEC 2014-03
• Study Type: interventional
• Target: 256
• Locations: 1 country
• Sites: 1

Brief 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

Head and Neck Squamous Cell Carcinoma

Keywords

Larynx, hypopharynx

Outcome Measures

Primary Outcomes (1)

• free survival

  Minimum time between randomization and the occurrence of events such as: death, total laryngectomy, tracheotomy.

  24 months after treatment initiation

Secondary Outcomes (4)

• Overall survival

  60 months

• Progression free survival

  60 months

• Larynx Preservation

  24 months after treatment initiation

• Feasibility of salvage surgery

  60 months after randomization

Study Arms (2)

TPF followed by radiotherapy

ACTIVE COMPARATOR

Induction chemotherapy by Docetaxel 75 mg/m² day 1,cisplatin 75 mg/m² day 1 and 5 fluorouracil 750mg/m²(day 1 to day 5) 3 cycles day1, day 22, day 43 followed (for responders or stable disease patients) by radiotherapy Radiotherapy ;70 gray fractionization: 2Gy/day, 5days/week, for 7 weeks.

Drug: Docetaxel; Drug: Cisplatin; Drug: Fluorouracil; Radiation: radiotherapy

Cisplatin and radiotherapy

EXPERIMENTAL

Drug and radiation • Cisplatin: 100 mg / m² administered IV at J1, J22 and J43 of radiotherapy . Radiotherapy 70 gray fractionization: 2Gy/day, 5days/week, for 7 weeks.

Drug: Cisplatin; Radiation: radiotherapy

Interventions

Docetaxel DRUG

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)

Also known as: Taxotere

TPF followed by radiotherapy

Cisplatin DRUG

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.

Also known as: Cisplatine

Cisplatin and radiotherapy; TPF followed by radiotherapy

Fluorouracil DRUG

5-FU, 750 mg / m² / day administered in continuous infusion from D1 to D5 (or 120 hours)

Also known as: 5 FU

TPF followed by radiotherapy

radiotherapy RADIATION

Radiotherapy : 70Gy (2Gy/day) for 7 weeks.

Also known as: radiation therapy

Cisplatin and radiotherapy; TPF followed by radiotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Squamous cell carcinoma of the larynx or hypopharynx, histologically proven, locally advanced:
• T2 not accessible to a supra-cricoid partial laryngectomy or not,
• T3 without massive infiltration by endolarynx transglottic injury,
• N0 to N2c
• No distant metastasis
• No associated cancer or earlier
• Patients Previously Untreated
• Age\> 18 years and \<75 years
• PS 0 or 1 according to WHO
• Tumor volume assessable by RECIST.
• Absence of distant metastasis, confirmed by chest TDM, abdominal ultrasound (or TDM) in case of abnormal liver function and bone scan if local symptoms.
• Absence of any concomitant cancer treatment.
• Absence of any chronic treatment ( ≥3 months) with a daily corticosteroid dose is ≥20 mg / day of methylprednisolone or equivalent.
• Hematological function: neutrophils ≥1.5 x 109 / L, platelets ≥100 x 109 / l, hemoglobin ≥10 g / dl (or 6.2 mmol / l).
• Hepatic function: normal total bilirubin; AST (SGOT) and ALT (SGPT) ≤ 2.5 x ULN (LNS) of each center; alkaline phosphatase ≤ 5 x LNS.

You may not qualify if:

• transglottic T3 with massive infiltration of hemilarynx or T4 with massive cartilaginous tumor lysis or reverse cricoarythénoïdenne region or posterior hypopharyngeal wall
• tumor requiring the completion of an immediately tracheotomy.
• Tumour available immediately to partial surgery.
• tumor requiring circular hypopharyngectomie
• N3 nodal injury
• Vaccination against yellow fever recent or anticipated
• Deficit known dihydropyrimidine dehydrogenase (DPD)
• Other malignancies within 5 years prior to randomization, with the exception of adequately treated basal skin cancer and carcinoma in situ of the cervix.
• Patients with AST or ALT\> 1.5xULN associated with alkaline phosphatase \> 2.5x LNS will not be eligible for testing.
• symptomatic neuropathy grade ≥2 with NCI-CTC.
• Clinical alteration of hearing function.
• Other concomitant serious medical conditions (partial list):
• Unstable cardiac disease despite treatment.
• Myocardial infarction within 6 months prior to trial entry.
• Neurological or psychiatric history such as dementia, seizures;

Sponsors & Collaborators

• Groupe Oncologie Radiotherapie Tete et Cou: lead

Study Sites (1)

Centre Jean Bernard

Le Mans, 72000, France

Location

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck; Laryngeal Diseases

Interventions

Docetaxel; Cisplatin; Fluorouracil; Radiotherapy

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Therapeutics

Study Officials

• Yoann POINTREAU, Dr

  Centre Jean Bernard

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2016
• First Posted: November 14, 2017
• Study Start: June 25, 2015
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): November 1, 2028
• Last Updated: September 2, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)