A Phase III Randomized Study of Chemo-radiotherapy Versus Radiotherapy Alone in the Adjuvant Treatment of Salivary Glands and Nasal Tumors (IMRT or Protontherapy)

GORTEC 2016-02

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)

2017-01-20

2030-02-01

2030-03-01

Recruiting

Early phase I

342

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. Exclusion Criteria: * 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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 342, 'type': 'ESTIMATED'}}

2023-09-25