Comparing two treatment regimen for sinuses tumors and salivary glands: radiotherapy versus chemoradiotherapy

Phase III randomized trial comparating concomittant administration of radiotherapy with cisplatin versus radiotherapy only for treatment of sinuses tumors and salivary glands

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-001816-39-FR

Enrollment

260

Registered

2016-10-10

Start date

2016-07-15

Completion date

Unknown

Last updated

2024-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

MedDRA version: 19.0 Level: PT Classification code 10060121 Term: Squamous cell carcinoma of head and neck System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Interventions

Trade Name: Cisplatine Accord Product Name: Cisplatine Pharmaceutical Form: Solution for infusion INN or Proposed INN: Cisplatine Other descriptive name: Cisplatine

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 310 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 310

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Main Objective: To Compare progression free survival (PFS) between the 2 treatment arms: RT only versus RT-CT as adjuvant therapy in surgical patients;Secondary Objective: ;Primary end point(s):	—

Countries

Belgium, France

Contacts

Public ContactCécile MICHEL

GORTEC

cecile.michel@gortec.fr33(0)4 92 03 15 95

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026