Clinical trial · Interventional
Trial of Laryngeal Preservation Comparing Induced CT Followed by RT vs CT Concomitant to RT
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
NCT03340896CI-TRIAL-00094397SALTORLactive not recruitingPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Squamous Cell Carcinoma | Head and Neck Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cisplatin | Drug | Cisplatin | ALIAS |
| Docetaxel | Drug | Docetaxel | ALIAS |
| Fluorouracil | Drug | Fluorouracil | ALIAS |
| radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- TPF followed by radiotherapy
- description
- 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.
- interventionNames
- Drug: Docetaxel
- Drug: Cisplatin
- Drug: Fluorouracil
- Radiation: radiotherapy
- type
- EXPERIMENTAL
- label
- Cisplatin and radiotherapy
- description
- 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.
- interventionNames
- Drug: Cisplatin
- Radiation: radiotherapy
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.