New chemo combo aims to help laryngeal cancer patients keep their voice
NCT ID NCT03340896
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This Phase 3 trial tests whether giving a three-drug chemotherapy regimen (docetaxel, cisplatin, and fluorouracil) before radiotherapy helps people with advanced laryngeal or hypopharyngeal cancer avoid losing their voice box. The standard approach is to give cisplatin during radiotherapy. The study enrolled 256 patients and tracks how many are alive without needing a laryngectomy or tracheostomy two years after treatment.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Docetaxel, cisplatin, and fluorouracil (chemotherapy drugs)
- What this could lead to
- If successful, this could show that a specific combination of chemotherapy and radiotherapy helps more people with advanced laryngeal cancer keep their voice box and avoid a laryngectomy.
- What could go wrong
- This is a Phase 3 trial, but results are not yet reported. The treatments involve strong chemotherapy with significant side effects, and there is no guarantee that the experimental arm will be better than the standard approach.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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256 people
The number who actually took part.
- Started
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Jun 2015
- Expected to finish
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Nov 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 participation in a clinical trial within 30 days prior to inclusion. * 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. * Renal function: serum creatinine ≤ 120 mol / l (1.4 mg / dl); if creatinine \> 120 mol / l, creatinine clearance should be ≥ 60 ml / min. * calculated creatinine clearance (Crockcroft formula) or measured ≥ 60 ml / min * Estimated life expectancy ≥ 3 months * Weight loss less than 10% over the last 3 months * Patient has given its written consent before any specific procedure of the Protocol. * Women and men of childbearing age should have accepted a medically effective contraception during the treatment period and at least 6 months after discontinuation of study treatments (Docetaxel, 5-Fluorouracil and Cisplatin. If pregnancy is declared by a patient or partner of a patient, it must be followed to know the evolution of pregnancy. Exclusion Criteria: * 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; * Severe uncontrolled infection. * Significant gastrointestinal abnormalities, including those that require parenteral nutrition, active peptic ulcer disease and a history of surgical procedures affecting absorption * Obstructive pulmonary disease requiring hospitalization in the year before inclusion. * Unstable diabetes or other cons-indications to corticosteroids. * Significant ophthalmologic abnormality. * Moderate or severe eczema. * Allergy to iodine. * Hypersensitivity to Docetaxel, Cisplatin or at one of their excipients. * Concomitant use of phenytoin, carbamazepine, barbiturates and rifampicin. * Presence, selection, psychological factors, family, social or geographical may alter patient compliance with the study protocol and follow-up, a criterion of non-inclusion. These factors should be discussed with the patient before inclusion in the trial. * Pregnant or nursing women. * Patient (male or female) of childbearing age not taking adequate contraceptive measures. * Patient deprived of their liberty, without guardianship or curatorship.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Centre Jean Bernard
Le Mans, 72000, France
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Other studies related to the condition(s) this trial covers.
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