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Study Comparing Radiotherapy Alone to Radiotherapy with Cisplatin for Patients with Sinus or Salivary Gland Tumors

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the treatment of tumors of the sinuses and salivary glands. These tumors can be either resected, meaning they have been surgically removed, or non-operable, meaning surgery is not an option. The study involves two treatment approaches: one group will receive radiotherapy alone, while the other group will receive a combination of radiotherapy and a chemotherapy drug called cisplatin. Cisplatin is administered as a solution for infusion, which means it is given through a vein.

The purpose of the study is to compare the effectiveness of these two treatment methods in preventing the progression of the disease. Participants will be randomly assigned to one of the two treatment groups. Throughout the study, participants will receive regular assessments to monitor their health and the progression of their condition. The study aims to determine which treatment approach offers better outcomes in terms of progression-free survival, which refers to the length of time during and after treatment that a patient lives with the disease without it getting worse.

In addition to progression-free survival, the study will also look at other important factors such as overall survival, quality of life, and the time it takes for the disease to progress locally or spread to other parts of the body. The study will also monitor any side effects that participants may experience, particularly those that are severe. The trial is expected to continue until 2030, with recruitment starting in 2024.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed based on specific criteria such as age, type of tumor, and overall health status.

    The study focuses on patients with tumors of the sinuses or salivary glands, including both resected and non-operable tumors.

  2. Step 2

    Treatment group assignment

    Participants are randomly assigned to one of two treatment groups: one receiving only radiotherapy and the other receiving a combination of radiotherapy and chemotherapy with cisplatin.

  3. Step 3

    Radiotherapy

    All participants undergo radiotherapy, which involves targeted radiation to treat the tumor. The frequency and duration of the sessions are determined by the medical team.

  4. Step 4

    Chemotherapy with cisplatin

    Participants in the chemoradiotherapy group receive cisplatin as a solution for infusion. The dosage is 1 mg/ml, and the administration schedule is set by the healthcare provider.

    The infusion is typically administered in cycles, with specific intervals between each cycle to allow the body to recover.

  5. Step 5

    Monitoring and follow-up

    Throughout the trial, regular monitoring is conducted to assess the treatment's effectiveness and any side effects.

    Participants attend scheduled follow-up appointments to evaluate progression-free survival and other health outcomes.

  6. Step 6

    End of trial

    The trial is expected to conclude by May 31, 2030. At the end of the trial, final assessments are made to determine the overall survival, quality of life, and any long-term effects of the treatments.

Who can join the trial?

6 criteria

  • Patients must have tumors of the sinuses or salivary glands that have been removed by surgery, or tumors that cannot be removed by surgery.
  • Patients with cancer of the main salivary glands, such as the parotid, submandibular, or sublingual glands, or malignant tumors of the sinuses, except for certain types like melanomas, lymphomas, sarcomas, squamous cell carcinomas, and nasopharyngeal carcinomas.
  • Patients must be 18 years old or older.
  • Patients must have a **performance index** from 0 to 2 according to the World Health Organization (WHO) criteria. This index measures how well a patient can perform daily activities.
  • For patients who are 70 years or older, they must have a **G8 questionnaire score** greater than 14, which assesses their health status, and they should not have had any falls in the past 12 months. Alternatively, they should have a geriatric assessment that shows they can receive chemotherapy.
  • Patients must have an estimated life expectancy of at least 6 months.

Who cannot join the trial?

4 criteria

  • Patients with **resected tumors** of the sinuses or salivary glands cannot participate. This means tumors that have been surgically removed.
  • Patients with **non-operable tumors** of the sinuses or salivary glands are excluded. These are tumors that cannot be removed through surgery.
  • Patients with **carcinomas of major salivary glands** are not eligible. Carcinomas are a type of cancer that starts in the skin or the tissue lining organs.
  • Patients with **malignant tumors** of the sinuses cannot join. Malignant tumors are cancerous and can spread to other parts of the body.
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Investigated drugs

  • Cisplatin

    is a chemotherapy medication used in this trial to help treat tumors of the sinuses and salivary glands. It works by stopping the growth of cancer cells. In this study, it is given together with radiotherapy to see if it improves the chances of the cancer not coming back after surgery.

  • Radiotherapy

    is a treatment that uses high doses of radiation to kill cancer cells and shrink tumors. In this trial, it is used alone in one group of patients and combined with cisplatin in another group to compare the effectiveness of these treatments in preventing cancer recurrence after surgery.

What is already known about the treatment

Cisplatin – Cisplatin is administered intravenously and is used in combination with radiotherapy for treating certain types of tumors, including those in the sinuses and salivary glands. It is currently being studied in clinical trials to evaluate its effectiveness in improving progression-free survival when used alongside radiotherapy. The main therapeutic indications include resected or non-operable tumors of the sinuses or salivary glands, as well as carcinomas of major salivary glands. At the molecular level, cisplatin works by binding to DNA and interfering with its replication, leading to cell death. It is classified as a platinum-based chemotherapy drug.

Investigated diseases

  • Resected Tumors of Sinuses or Salivary Glands

    These are tumors that have been surgically removed from the sinuses or salivary glands. The progression involves monitoring for any recurrence or regrowth of the tumor in the affected area.

  • Non-operable Tumors of Sinuses or Salivary Glands

    These tumors cannot be surgically removed due to their location or size. They may continue to grow and potentially affect nearby structures, leading to symptoms such as pain or difficulty in swallowing.

  • Carcinomas of Major Salivary Glands

    This is a type of cancer that originates in the major salivary glands. The disease progresses as the cancer cells grow and potentially spread to nearby tissues or other parts of the body.

  • Malignant Tumors of Sinuses

    These are cancerous growths located in the sinus cavities. The progression of the disease involves the potential for the tumor to invade surrounding tissues and possibly metastasize to other areas.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-513972-16-00Protocol codeGORTEC 2016-02Estimated enrolment342 patientsSponsorGroupe Oncologie Radiotherapie Tete Cou

sourced from the EU Clinical Trials Register and site verification

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