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

NCT02998385 | Active Not Recruiting Phase 3 DMC

• 1 other identifier: GORTEC 2016-02
• Study Type: interventional
• Target: 342
• Locations: 1 country
• Sites: 1

Brief 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)

Conditions

HNSCC

Keywords

salivary glands; sinus carcinoma; radiochemotherapy concomitant; cisplatin; protontherapy

Outcome Measures

Primary Outcomes (1)

• Progression-free survival

  Compare progression-free survival between the 2 treatment arms: radiation therapy alone versus radiochimiotherapy in adjuvant patients treatment operated.

  From date of randomization to date of disease progression or death, which occur first, assessed during 62 months

Secondary Outcomes (1)

• Overall Survival

  From date of randomization to date of death, assessed during 62 months

Other Outcomes (1)

• Assessment of quality of Life: QLQC30 overall score

  From date of randomization to end of study or death or progression (the first occurred), assessed during 62 months

Study Arms (2)

Radiotherapy

ACTIVE COMPARATOR

Arm A Radiation therapy: 66 to 70 Gy in fractions of 2 Gy, 1 fraction/day, 5 fractions per week. Radiation therapy will be conducted by conformational intensity modulation radiotherapy (IMRT) or protontherapy. Irradiation by 3D conformational radiotherapy can be discussed on a case by case with the Intergroup Coordinator GORTEC.

Radiation: radiotherapy

Radiotherapy + concomitant cisplatin

EXPERIMENTAL

Arm B Concomitant systemic treatment with cisplatin + radiotherapy According to standard protocol of concomitant cisplatin 100 mg/m2 IV on day 1 - J22 - 43 (3 maximum cycles). Radiation therapy: 66 to 70 Gy in fractions of 2 Gy, 1 fraction/day, 5 fractions per week. Radiation therapy will be conducted by conformational intensity modulation radiotherapy (IMRT) or protontherapy. Irradiation by 3D conformational radiotherapy can be discussed on a case by case with the Intergroup Coordinator GORTEC

Drug: Cisplatin; Radiation: radiotherapy

Interventions

Cisplatin DRUG

intravenous, concomitant to irradiation

Radiotherapy + concomitant cisplatin

radiotherapy RADIATION

66 à 70 Gy per fractions of 2 Gy, 1 fraction/day, 5 fractions/week

Radiotherapy; Radiotherapy + concomitant cisplatin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Groupe Oncologie Radiotherapie Tete et Cou: lead
• National Cancer Institute, France: collaborator

Study Sites (1)

Hôpital Bégin

Saint-Mandé, 94, France

Location

Related Publications (2)

• Ferrari M, Orlandi E, Bossi P. Sinonasal cancers treatments: state of the art. Curr Opin Oncol. 2021 May 1;33(3):196-205. doi: 10.1097/CCO.0000000000000726.

  PMID: 33756515 DERIVED

• Joshi NP, Broughman JR. Postoperative Management of Salivary Gland Tumors. Curr Treat Options Oncol. 2021 Feb 9;22(3):23. doi: 10.1007/s11864-021-00820-9.

  PMID: 33560478 DERIVED

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

Cisplatin; Radiotherapy

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2016
• First Posted: December 20, 2016
• Study Start: January 20, 2017
• Primary Completion (Estimated): February 1, 2030
• Study Completion (Estimated): March 1, 2030
• Last Updated: May 7, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)