Not recruiting

Study of NBTXR3 and Cetuximab with Radiotherapy for Elderly Patients with Advanced Head and Neck Cancer Not Eligible for Platinum Chemotherapy

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 a type of cancer called Locally Advanced Head & Neck Squamous Cell Carcinoma. This cancer affects areas such as the mouth, throat, and voice box. The study is exploring a new treatment approach using a special material called NBTXR3, which is a sterile implantable nanomaterial. This material is injected directly into the tumor to help improve the effects of radiation therapy, which is a common treatment for cancer that uses high-energy rays to kill cancer cells.

The trial will compare the effectiveness of using NBTXR3 with radiation therapy alone or in combination with a medication called Cetuximab. Cetuximab is a type of protein used to treat certain cancers by blocking the growth of cancer cells. The study aims to see if this combination can improve survival outcomes for patients who cannot receive a standard chemotherapy treatment known as platinum-based chemotherapy. This is particularly relevant for elderly patients who may not tolerate standard treatments well.

Participants in the study will receive either the new treatment combination or the standard treatment, which may include radiation therapy with or without Cetuximab. The study will monitor the participants over time to assess how well the treatments work in controlling the cancer and improving survival. The goal is to find out if the new treatment approach can offer better results for patients with this type of cancer.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, the patient will have signed an informed consent form, indicating understanding of the study's purpose and procedures.
The patient must meet specific health criteria, including adequate organ and bone marrow function, and must be at least 60 years old.
Step 2
Initial assessment
The patient will undergo an initial assessment to confirm eligibility, including a biopsy to confirm the type of cancer and other health evaluations.
The patient's tumor must be suitable for direct injection, and they must be unable to receive platinum-based chemotherapy.
Step 3
Treatment planning
The treatment plan will be developed, which may include radiotherapy alone or in combination with cetuximab, depending on the investigator's choice.
Cetuximab is administered as an intravenous infusion, with the dosage and frequency determined by the study protocol.
Step 4
Treatment phase
The patient will receive NBTXR3 injected directly into the tumor, followed by radiotherapy, with or without cetuximab.
The treatment aims to evaluate survival outcomes and is expected to continue until the study's estimated end date in April 2027.
Step 5
Monitoring and follow-up
Throughout the study, the patient will be monitored for any progression of the disease or side effects from the treatment.
Regular follow-up appointments will be scheduled to assess the patient's health and response to the treatment.

Who can join the trial?

12 criteria

You must sign a form that shows you understand the study and agree to take part.
You should be 60 years old or older.
You need to have a confirmed type of cancer in specific areas like the mouth or throat. If no previous samples are available, a new sample must be taken.
If you have a type of throat cancer, your HPV status must be known.
Your tumor should be in certain stages as defined by medical guidelines.
You must have one main tumor that can be injected directly with the study treatment.
You should not be able to receive a specific type of chemotherapy due to certain health conditions or age.
You must be able to handle radiation therapy aimed at curing the cancer.
You should be suitable for a specific type of treatment with radiation therapy. If you have mouth cancer, surgery should not be the primary treatment option, and a team of specialists must agree on the radiation therapy plan.
Your general health should be good enough to participate, as measured by a specific performance status scale.
You should have a life expectancy of at least 6 months.
Your organs and bone marrow need to be functioning well, as shown by specific blood tests and other health measures.

Who cannot join the trial?

7 criteria

Patients who have a different type of cancer than the one being studied cannot participate.
Patients who have had previous treatments that might interfere with the study cannot participate.
Patients with certain medical conditions that could affect the study results cannot participate.
Patients who are unable to follow the study procedures cannot participate.
Patients who are pregnant or breastfeeding cannot participate.
Patients who are not able to give their consent to participate cannot participate.
Patients who are part of another clinical trial cannot participate.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Athens Medical Center S.A.
Verified
Thessaloniki, Greece
Justus-Liebig-Universitaet Giessen
Verified
Giessen, Germany
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)
Verified
Munich, Germany

Trial locations

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Investigated drugs

NBTXR3
is a new type of treatment that is injected directly into the tumor. It is designed to enhance the effects of radiation therapy. In this study, it is being tested to see if it can improve survival outcomes for patients with a specific type of head and neck cancer.
Radiotherapy
is a common cancer treatment that uses high doses of radiation to kill cancer cells and shrink tumors. In this trial, radiotherapy is used either alone or in combination with other treatments to see how well it works with NBTXR3.
Cetuximab
is a medication used to treat certain types of cancer. It works by targeting and blocking a protein that helps cancer cells grow. In this study, cetuximab is used in combination with radiotherapy to see if it can improve treatment outcomes for patients who cannot undergo platinum-based chemotherapy.

Cetuximab

What is already known about the treatment

NBTXR3 – NBTXR3 is administered through direct injection into the tumor, specifically for patients with locally advanced head and neck squamous cell carcinoma. It is currently being studied in clinical trials to assess its effectiveness when activated by radiotherapy, with or without the addition of cetuximab, particularly in elderly patients who cannot undergo platinum-based chemotherapy. The main therapeutic indication is to improve survival outcomes in these patients. At the molecular level, NBTXR3 works by enhancing the effects of radiotherapy, making cancer cells more susceptible to radiation damage. It is classified as a radio-enhancer in pharmacology.

Investigated diseases

Locally Advanced Head and Neck Squamous Cell Carcinoma – This is a type of cancer that occurs in the squamous cells lining the moist surfaces inside the head and neck. It is considered locally advanced when the cancer has spread from its original site to nearby tissues or lymph nodes but not to distant parts of the body. The progression of this disease can involve the growth of tumors in areas such as the throat, mouth, or nasal passages, potentially affecting speech, swallowing, and breathing. As the disease advances, it may cause symptoms like persistent sore throat, difficulty swallowing, unexplained weight loss, and changes in voice. The condition is often linked to risk factors such as tobacco use, alcohol consumption, and human papillomavirus (HPV) infection. Early detection and monitoring are crucial for managing the disease's progression.