Etude : SANTAL / GORTEC 2016 02

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Acronyme / Nom
Situation thérapeutique
Cadre réglementaire
Présentation de l'étude
Acronyme / Nom : SANTAL / GORTEC 2016 02

Situation thérapeutique : Néoadjuvant

Traitement : Chimiothérapie / Radiothérapie

Cadre réglementaire : RIPH1

Dernière MÀJ : 30/11/2021
CIM10 - Localisation(s)
Informations principales
Titre : Etude de phase III randomisée de chimio-radiothérapie versus radiothérapie seule pour le traitement des tumeurs des sinus et des glandes salivaires

Spécialité : Lèvre, cavité buccale et pharynx
Localisation : C08 - Tumeur maligne des glandes salivaires principales, autres et non précisées

Spécialité : Organes respiratoires et intrathoraciques
Localisation : C31 - Tumeur maligne des sinus de la face
Informations complémentaires
Schéma : A phase III, multicenter, randomized, open-label, french study comparing:
- Arm A : Radiotherapy alone (66 to 70 Gy; 5 fractions/week; 1fraction/day; 2 Gy/fraction)
- Arm B: Radiotherapy (66 to 70 Gy; 5 fractions/week; 1fraction/day; 2 Gy/fraction) + concomitant cisplatin 100 mg/m2 IV on day 1 - J22 - 43 (3 cycles)

Patient can also be treated by protontherapy

Phase : III

Stade : Localisé à Métastatique

Informations libres de droit
Critères d'inclusion
Critères de non-inclusion
Informations libres de droit
Critères d'inclusion et de non-inclusion
Critères d'inclusion : - Resected tumors of the sinus or the salivary glands T3-4, N1-3 or T1-2 N0, with overgrown banks or positive margins (< 5 mm)
- Unresectable or not operable tumors of salivary glands or sinuses

- Carcinomas of the major salivary glands (Parotid, submandibular and sublingual glands) and accessories with the following histologies: adenoid cystic Carcinoma, adenocarcinoma without another indication (SAI) of high-grade, muco-epidermoid of intermediate grade or high grade Carcinoma, salivary ductal carcinoma, carcinomas to turn cells (with dedifferencie contingent or Ki 67 > 10%), Sebaceous Carcinoma, large cell carcinoma, small cell carcinomas Mucinous adenocarcinoma, carcinoma on massively invasive Pleomorphic adenoma, oncocytic carcinomas, myoepithelial Carcinoma
Malignant tumors of the sinus with the following histology: adenocarcinomas of the ethmoid (ADE) of bowel and no intestinal type, CF adenoids carcinomas and other carcinomas of salivary origin (COS).

- Age ≥ 18 years

- Performance status 0 -2 (WHO criteria)

- For patients ≥ 70 years, the score to the G8 questionnaire must be > 14 with no fall in the previous 12 months or with a geriatric assessment consistent with the administration of chemotherapy

- Estimated life expectancy greater than or equal to 6 months

- Neutrophils > 1.5 x 109/l, platelets > 100 x 109/l, hemoglobin ≥ 9.5 g/dl, bilirubin ≤ 3 x upper normal value (ULN), AST/ALT < 5 ULN, PAL < 3 ULN

- Creatinin Clearance ≥ 60 mL/min

- Adequate cardiac function according to the investigator, compatible with the administration of cisplatin 100 mg/m²

- Affiliation to a social insurance or beneficiary of such a regimen

- Patient having given his written consent signed before any study specific procedure.

Critères de non-inclusion : - History of radiation therapy in the ENT area

- Synchronous metastases

- Contraindications for administration of cisplatin or carboplatin

- Allergy to cisplatin and/or its excipients

- Melanoma, lymphoma, tumors of mesenchymal (of type Sarcoma), epidermoid carcinomas, (SCUNC) neuroendocrine carcinomas and carcinoma undifferentiated (SNUC), nasopharyngeal carcinomas type 1, 2, and 3.

- Vaccination against yellow fever, recent or planned

- Administration of phenytoin with prophylactic purpose

- Other cancer, except for cancer in situ of the cervix, skin Carcinoma (except melanoma) or cancer controlled for more than 5 years

- Pregnant, breastfeeding or without birth control woman. Woman having the ability to procreate should have (serum or urinary) negative pregnancy test within 14 days prior to study treatment decision-making. (Men or women) patients should use a reliable contraceptive method throughout the treatment and at least 6 months after the end of chemotherapy.

- Persons deprived of liberty under supervision or under curatorship, or unable to adhere to medical follow-up of the study for geographical, social or psychological reasons.
Informations relatives au promoteur
Promoteur :
Groupe Oncologie Radiothérapie Tête et Cou (GORTEC)
Type de sponsor : Institutionnel
37000 TOURS

Coordonnateur :
Centre investigateur
Informations relatives aux investigateurs
Centre investigateur :
Centre François BACLESSE - 3 avenue du Général Harris - 14000 CAEN
Apicrypt :

Investigateur :


Statut de l'essai : OUVERT

MAJ : 02/02/2018