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

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What is this study about?

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.

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 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 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 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 Study?

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 Study?

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

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Nzxvhfie Ilumspsx Oznhykqrq Izw Mtfxj Snkpyzwmvbfjakvjvieonsohpjkj Iknojwiy Bxjywqxm	Cracow	Poland

Trial status

Country	Status	Recruitment Start
Poland	Recruiting	02.01.2022

Trial locations

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.

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 ID:

2024-517480-23-00

Protocol code:

iCHRTL/2021

Trial Phase:

Therapeutic exploratory (Phase II)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?