Etude : SALTORL /



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Acronyme
Nom
Traitement
Type d'étude
MÀJ
Présentation de l'étude
Acronyme : SALTORL

Nom :

Traitement : Néoadjuvant / Radiothérapie

Type d'étude : Hors ciblage moléculaire

Dernière MÀJ : 06/08/2019
Titre
Spécialité(s)
CIM10 - Localisation(s)
Informations principales
Titre : Etude de phase III de préservation laryngée comparant une chimiothérapie d’induction associant le Cisplatine, le 5-Fluorouracile et le Docétaxel (TPF) suivie de radiothérapie à une radiothérapie associée à l’administration concomitante de Cisplatine

Spécialité : Lèvre, cavité buccale et pharynx
Localisation : C13 - Tumeur maligne de l'hypopharynx

Spécialité : Organes respiratoires et intrathoraciques
Localisation : C32 - Tumeur maligne du larynx
Schéma
Phase
Stade
Ligne(s)
Informations complémentaires
Schéma : 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.

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.

2 treatment arms:

- Active Comparator: TPF followed by radiotherapy
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.

- Experimental: Cisplatin and radiotherapy
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.

Phase : III

Stade : Localisé à Localement avancé

NA
Critères d'inclusion
Critères de non-inclusion
Critères d'inclusion et de non-inclusion
Critères d'inclusion : - 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

Critères de non-inclusion : - 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.
NCT
Promoteur
Coordonnateur
Informations relatives au promoteur
NCT :
NCT03340896
Promoteur :
Groupe Oncologie Radiothérapie Tête et Cou (GORTEC)
Type de sponsor : Institutionnel
37000 TOURS

Coordonnateur :
Centre investigateur
Investigateur
TEC / ARC / IDE
État
MÀJ
Informations relatives aux investigateurs
Centre investigateur :
CHU de Caen - Avenue de la Côte de Nacre - 14033 Caen Cedex - 14000 CAEN

Investigateur :
Emmanuel BABIN

TEC / ARC / IDE :
Esther LEBRETON
lebreton-e@
chu-caen.fr

Ouverture de l'essai : OUVERT

MAJ : 02/02/2018

Centre investigateur :
Centre François BACLESSE - 3 avenue du Général Harris - 14000 CAEN

Investigateur :
Dominique DE RAUCOURT

TEC / ARC / IDE :
Karim HAMOND
k.hamond@
baclesse.unicancer.fr

Ouverture de l'essai : OUVERT

MAJ : 02/02/2018