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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.
Full 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.
Enrollment
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Inclusion criteria
Squamous cell carcinoma of the larynx or hypopharynx, histologically proven, locally advanced:
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):
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.
Primary purpose
Allocation
Interventional model
Masking
256 participants in 2 patient groups
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Central trial contact
Adeline PECHERY; Yoann POINTREAU, Dr
Data sourced from clinicaltrials.gov
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