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Head and Neck Squamous Cell CarcinomaPhase 3SALTORLNCT03340896

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

A Phase 3 study testing Docetaxel, Cisplatin and Fluorouracil in people with Head and Neck Squamous Cell Carcinoma, run by Groupe Oncologie Radiotherapie Tete et Cou at 1 site in France.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Head and Neck Squamous Cell Carcinoma
What is being tested?
Docetaxel, Cisplatin and Fluorouracil
Could I receive a placebo?
No, everyone receives an active treatment
How many people
256 participants
Where
1 siteFrance
Study dates
25 Jun 2015to Nov 2028
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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.

Who cannot join

  • 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
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  • 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.

Trial locations and contacts

1 site in 1 country.

France1 site

  • Centre Jean Bernard

    Le Mans, 72000

Other trials in France

About this study

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

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.

Read the detailed description

In patients with tumors classified as T3 or T4 larynx and hypopharynx, the usually recommended treatment was total laryngectomy.This intervention allows to obtain locoregional disease control in 75% of cases, without laryngectomy

TPF arm followed by radiotherapy was validated in a Phase III (GORTEC 2000-01), it will be the standard treatment.

The RTOG study concluded that chemotherapy administrated during radiotherapy became a standard of laryngeal preservation.

Taking together all these considerations, it is necessary to perform a direct comparison in a randomized trial to further test this hypothesis. Chemotherapy followed by radiotherapy will be the standard arm. It hopes to increase the survival rate from 52% to 65% in the experimental arm.

Being tested
Docetaxel, Cisplatin, Fluorouracil, radiotherapy
Keywords
Larynx, hypopharynx
Medical subject headings
Squamous Cell Carcinoma of Head and Neck, Laryngeal Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DocetaxelDrug

    Also called Taxotere

    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)

  • CisplatinDrug

    Also called Cisplatine

    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.

  • FluorouracilDrug

    Also called 5 FU

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

  • radiotherapyRadiation

    Also called radiation therapy

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

Study groups in NCT03340896
Study groupRoleWhat they receive
TPF followed by radiotherapyActive comparatorInduction 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.
Receives: Drug: Docetaxel; Drug: Cisplatin; Drug: Fluorouracil; Radiation: radiotherapy
Cisplatin and radiotherapyExperimentalDrug 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.
Receives: Drug: Cisplatin; Radiation: radiotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. free survival

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

    Measured: 24 months after treatment initiation

Secondary outcomes (4)

  1. Overall survival

    "From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months").

    Measured: 60 months

  2. Progression free survival

    "From date of randomization until the date of first documented progression assessed up to 60 months").

    Measured: 60 months

  3. Larynx Preservation

    From date of randomization up to 24 months evaluated by dynamic deglutition videoscopy

    Measured: 24 months after treatment initiation

  4. Feasibility of salvage surgery

    Assessing the number of recurrences that could be successfully treated with salvage surgery and description of postoperative

    Measured: 60 months after randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Nov 2017
  2. Study start25 Jun 2015
  3. Primary completionOct 2028 (estimated)
  4. Study completionNov 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
256 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03340896
Sponsor's protocol ID
GORTEC 2014-03
Acronym
SALTORL
Status last verified
Sep 2026
First submitted
8 Mar 2016
Last updated
2 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Docetaxel, Cisplatin and Fluorouracil in people with Head and Neck Squamous Cell Carcinoma, run by Groupe Oncologie Radiotherapie Tete et Cou at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 22 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

free survival (time frame: 24 months after treatment initiation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03340896.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.

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