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Study of low-dose radiation therapy combined with paclitaxel and carboplatin in patients with advanced throat and larynx cancer

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 focuses on patients with advanced throat and larynx cancer. The study evaluates a treatment approach called induction radiochemotherapy that uses low doses of ionizing radiation combined with chemotherapy medications. The chemotherapy drugs used in this study are paclitaxel and carboplatin, which are given through an intravenous injection directly into the bloodstream.

The purpose of this research is to determine how effective and well-tolerated this combined treatment approach is for patients with advanced throat and larynx cancer. The treatment involves receiving both chemotherapy medications along with low-dose radiation therapy. During the study, patients will receive treatment over a period of up to 37 days.

The study will monitor how patients respond to the treatment by examining the cancer's response, checking for any spread of the disease, and tracking overall patient survival. The research will also look at how low doses of radiation affect the body at both molecular and biochemical levels. Throughout the treatment period, doctors will carefully watch for and record any side effects that patients may experience.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial treatment phase

    Your treatment will begin with induction radiochemotherapy using low doses of radiation combined with chemotherapy medications

    You will receive two medications through an intravenous line: Paclitaxel and Carboplatin

    The medications will be given as a solution directly into your vein

  2. Step 2

    Monitoring during treatment

    Your medical team will regularly assess how your body responds to the treatment

    They will check for any side effects in different parts of your body

    The effectiveness of the treatment will be measured by examining how the cancer responds locally and in the lymph nodes

  3. Step 3

    Follow-up assessments

    Your medical team will check if the cancer has spread to other parts of your body

    Regular examinations will track your overall health and recovery

    The medical team will monitor for any signs that the cancer has returned

    Your progress will be tracked to measure how long you remain free from cancer progression

  4. Step 4

    Long-term monitoring

    Your treatment and follow-up will continue until December 2028

    The medical team will continue to monitor your overall survival and health status

    Regular checkups will help ensure any potential return of cancer is detected early

Who can join the trial?

9 criteria

  • Must have advanced cancer of the throat (upper, middle, or lower part) or larynx (voice box) that has not been treated before
  • Cancer must be at a specific stage:
    • Lymph node involvement (N1) larger than 2 cm, or N2 or N3 stage
    • Tumor size (T2, T3, or T4)
    • No distant spread of cancer (M0)
    • Must be healthy enough to receive induction chemotherapy (initial cancer treatment using drugs)
    • Must not have other serious medical conditions that would prevent chemotherapy treatment
    • Must be at least 18 years old
    • Must be willing and able to sign an informed consent form for study participation
    • Both men and women can participate in the study

Who cannot join the trial?

14 criteria

  • Age below 18 years or above 65 years
  • Presence of distant metastases (cancer that has spread to other parts of the body)
  • Previous radiotherapy treatment in the head and neck area
  • Active or uncontrolled infections
  • Significant heart problems or uncontrolled heart disease
  • Severe kidney or liver dysfunction
  • Pregnancy or breastfeeding
  • Participation in other clinical trials within the last 30 days
  • Mental conditions that prevent understanding of the trial requirements
  • Known allergies to study medications
  • Immunodeficiency (weakened immune system) or autoimmune diseases
  • Uncontrolled diabetes mellitus (high blood sugar)
  • Active substance abuse or alcoholism
  • Inability to follow study procedures
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Investigated drugs

Radiotherapy - This is a treatment that uses ionizing radiation at low doses to target and destroy cancer cells in the throat and larynx area. The radiation is delivered in carefully controlled amounts to minimize damage to healthy tissue while treating the cancer. Chemotherapy - This treatment works together with radiation therapy (combined as radiochemotherapy) to make cancer cells more sensitive to radiation and help destroy them more effectively. The specific chemotherapy medications are not mentioned in the source data, but they are used in combination with radiation to treat advanced throat and larynx cancer. The treatment approach combines both therapies (radiochemotherapy) using lower doses of radiation than standard treatment protocols to evaluate its effectiveness and how well patients tolerate it.

What is already known about the treatment

Since no specific medication names are provided in the source data, and the trial appears to focus on radiochemotherapy treatment, I can describe the general therapeutic approach used in this type of cancer treatment: Radiochemotherapy - A combined treatment approach that uses both radiation therapy and chemotherapy to treat advanced throat and larynx cancer. The therapy involves the administration of low-dose ionizing radiation (external beam radiation) together with chemotherapy drugs, delivered according to a specific schedule. This treatment method works by damaging cancer cells' DNA and preventing them from dividing and growing, while the combination of both therapies can provide better results than either treatment alone. Radiochemotherapy belongs to the class of multimodal cancer treatments and is commonly used as an induction (initial) therapy for advanced head and neck cancers.

Investigated diseases

  • Throat Cancer

    A disease that develops when abnormal cells begin growing in the tissues of the throat (pharynx). The condition typically starts in the flat squamous cells that line the throat, gradually forming tumors that can affect swallowing, speaking, and breathing. The disease can spread to nearby tissues and lymph nodes in the neck area. As it progresses, it may cause persistent sore throat, difficulty swallowing, and changes in voice quality.

  • Laryngeal Cancer

    A condition where malignant cells form in the tissues of the larynx (voice box). It begins in the squamous cells lining the larynx and can affect the vocal cords and surrounding areas. The disease typically develops gradually, affecting voice production and breathing. As it advances, it can cause persistent hoarseness, difficulty breathing, ear pain, and a feeling of a lump in the throat.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-517480-23-00Protocol codeiCHRTL/2021Estimated enrolment40 patientsSponsorNarodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie-Panstwowy Instytut Badawczy

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