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

• Status: Recruiting
• Trial end date: 2028-09-24
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Groupe Oncologie Radiotherapie Tete et Cou
• Treatments: Cisplatin; Docetaxel; Fluorouracil

Criteria

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

• VHI and DHI questionary

• Quality of Life Questionnaire QLQ-C30 and QLQ-H & N35

• 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.

• Dynamic Vidéoscopie of deglutition

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.