Informations générales (source: ClinicalTrials.gov)

NCT02998385 En recrutement IDF
A Phase III Randomized Study of Chemo-radiotherapy Versus Radiotherapy Alone in the Adjuvant Treatment of Salivary Glands and Nasal Tumors (IMRT or Protontherapy) (SANTAL)
Interventional
  • Tumeurs du nez
Phase 3
Groupe Oncologie Radiotherapie Tete et Cou (Voir sur ClinicalTrials)
janvier 2017
mars 2030
11 juillet 2024
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) (IMRT or protontherapy) - Arm B: Radiotherapy (66 to 70 Gy; 5 fractions/week; 1fraction/day; 2 Gy/fraction; IMRT or protontherapy) + concomitant cisplatin 100 mg/m2 IV on day 1 - J22 - 43 (3 cycles)
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Etablissements

Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données
CHI DE CRETEIL Xavier CUENCA En recrutement IDF 29/03/2024 01:27:16  Contacter
CLCC INSTITUT CURIE Active, sans recrutement 04/09/2024 13:49:50 Contact (sur clinicalTrials)
CLCC INSTITUT GUSTAVE ROUSSY Yun Gan TAO En recrutement IDF 11/04/2024 10:58:26 Contact (sur clinicalTrials)
Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
CDS ACCES VISION SAINT MANDE François Régis FERRAND, MD En recrutement IDF Contact (sur clinicalTrials)

Critères

Tous
Inclusion Criteria:

- 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)

or

Unresectable or not operable tumors of salivary glands or sinuses

- Carcinomas of the main salivary glands (parotid, submandibular or sublingual glands)
and accessories or Malignant sinus tumors with any histological type except
melanoma, lymphoma, mesenchymal tumor (sarcoma type), squamous cell carcinoma and
nasopharyngeal carcinoma type 1, 2, 3.

- 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 (Cockroft formula)

- 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.


- History of radiotherapy in the ENT region and/or neoadjuvant chemotherapy for the
pathology concerned

- Synchronous metastases

- Contraindications for administration of cisplatin or carboplatin

- Allergy to cisplatin and/or its excipients

- 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.