Chemo-radiotherapy Versus Radiotherapy in the Treatment of Salivary Glands and Nasal Tumors (IMRT or Protontherapy)

• Status: Recruiting
• Trial end date: 2026-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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)

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Groupe Oncologie Radiotherapie Tete et Cou
• Collaborator: National Cancer Institute, France
• Treatments: Cisplatin

Criteria

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 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

or

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.

Exclusion Criteria:

• 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.