Authorised Therapeutic confirmatory (Phase III) - Resected tumors of sinuses or salivary glands - Non-operable tumors of sinuses or salivary glands - Carcinomas of major salivary glands - Malignant tumors of sinuses

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

EU CTIS ID: 2024-513972-16-00

What this study is testing

To Compare progression free survival (PFS) between the 2 treatment arms: RT only versus RT-CT as adjuvant therapy in surgical patients

  • Therapeutic confirmatory (Phase III)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • Resected tumors of the sinuses or salivary glands: T3-4 N0 or T1-4 N1-3 or T1-2 N0 with invaded edges or positive margins (< 5 mm) or Unresectable or inoperable tumors of the sinuses or salivary glands
  • Carcinomas of the main salivary glands (parotid, submandibular or sublingual glands) and accessories or Malignant tumors of the sinuses with any histological type except melanomas, lymphomas, mesenchymal tumors (sarcoma type), squamous cell carcinomas and nasopharyngeal carcinomas of type 1, 2, 3.
  • Age ≥ 18 years
  • Performance index according to the World Health Organization (WHO) criteria from 0 to 2
  • For patients ≥ 70 years, the G8 questionnaire score must be > 14 with no falls noted in the previous 12 months or presenting a geriatric assessment compatible with the administration of chemotherapy
  • Estimated life expectancy greater than or equal to 6 months

You likely can't join if

  • History of radiotherapy in the ENT region and/or neoadjuvant chemotherapy for the pathology concerned
  • Synchronous metastases
  • Contraindications to the administration of cisplatin or carboplatin
  • Other cancer, except in situ cervical cancer, skin carcinoma (except melanoma) or cancer controlled for more than 5 years

The study team makes the final eligibility decision.

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.