Study on Radiotherapy with Xevinapant or Placebo for Older Patients with Advanced Head and Neck Cancer

What is this study about?

This clinical trial is focused on studying a type of cancer called squamous cell carcinoma of the head and neck. This cancer affects areas such as the mouth, throat, and voice box. The study is investigating the effects of a treatment called xevinapant, which is also known by its code name Debio 1143. Xevinapant is taken as an oral solution, meaning it is a liquid that is swallowed. The trial will compare the effects of xevinapant combined with radiotherapy to a placebo combined with radiotherapy. A placebo is a substance with no active medication.

The purpose of the study is to see if adding xevinapant to radiotherapy can help improve the time patients live without the cancer coming back or getting worse. The study will involve older patients who have locally advanced head and neck cancer, which means the cancer has spread to nearby tissues but not to distant parts of the body. Participants will receive either xevinapant or a placebo along with their radiotherapy treatment. The study will monitor how long patients remain free from cancer progression and will also look at overall survival, response to treatment, and any side effects experienced.

Throughout the study, patients’ health and quality of life will be assessed using various scales and questionnaires. The trial aims to provide valuable information on whether xevinapant can offer additional benefits to standard radiotherapy in treating this type of cancer. The study is expected to continue until June 2030, with recruitment having started in September 2023.

1 joining the study

Upon joining the study, you will be asked to provide written informed consent. This means you agree to participate after understanding the details and potential risks of the study.

2 initial assessment

An initial assessment will be conducted to confirm eligibility. This includes checking your age, medical history, and current health status. You must be 70 years or older and have a new diagnosis of head and neck squamous cell carcinoma.

3 treatment assignment

You will be randomly assigned to receive either xevinapant or a placebo. A placebo is a substance with no active medication, used to compare effects.

4 medication administration

If assigned to the xevinapant group, you will take the medication orally as a solution. The dosage and frequency will be specified by the study team.

5 radiotherapy

You will undergo radiotherapy, which is a treatment using radiation to kill cancer cells. This is part of the standard treatment for your condition.

6 regular monitoring

Throughout the study, regular monitoring will occur to assess your health and response to treatment. This includes physical exams, blood tests, and imaging studies.

7 quality of life assessments

You will be asked to complete questionnaires about your quality of life, including physical functioning and any symptoms like fatigue or pain.

8 end of study

The study is expected to end by June 2030. At the conclusion, your overall health and treatment outcomes will be evaluated.

Who Can Join the Study?

Must be 70 years or older.
Must sign a written informed consent form, which is a document that explains the study and confirms your agreement to participate.
Must have a new diagnosis of squamous cell carcinoma in the head and neck area, specifically in the oral cavity, oropharynx, hypopharynx, or larynx.
Must have a specific stage of cancer, described as cT3-4 cN0 cM0 or cT1-4 cN1-3 cM0, except for cT1-2 cN1 p16 positive oropharyngeal cancer (based on the AJCC 8th edition).
Must have HPV status available for oropharyngeal squamous cell carcinoma, determined by a test called p16 immunohistochemistry (IHC).
Must have a measurable disease according to a standard called RECIST 1.1, which is a way to measure cancer size and response to treatment.
Must have an ECOG performance status of 0 or 1, which means you are fully active or have some symptoms but can carry out light work.
Must plan to receive primary radiotherapy with the goal of curing the cancer.
Must be able to swallow liquids or have a functioning feeding tube.
Must have adequate blood, kidney, and liver function, shown by specific medical tests:
- Creatinine clearance of at least 30 mL/min, which measures kidney function.
- Absolute neutrophil count of at least 1,500 cells/μL, which is a type of white blood cell important for fighting infections.
- Platelets of at least 100,000 cells/μL, which are cells that help with blood clotting.
- Hemoglobin of at least 9.0 g/dL or 5.6 mmol/L, which is a protein in red blood cells that carries oxygen (blood transfusions during screening are allowed).
- AST and ALT levels no more than 3 times the upper limit of normal, which are enzymes that indicate liver health.
- Total bilirubin no more than 1.5 times the upper limit of normal, or up to 2 times if the direct bilirubin level is normal and the increase is due to indirect bilirubin.

Who Cannot Join the Study?

Patients with any other type of cancer besides squamous cell carcinoma of the head and neck cannot participate. This type of cancer affects certain cells in the head and neck area.
Patients who have had another cancer in the past, unless it was successfully treated and has not come back for at least 5 years, are excluded.
Patients who have received radiation therapy or chemotherapy for their cancer before cannot join the study. Radiation therapy uses high-energy rays to kill cancer cells, and chemotherapy uses drugs to do the same.
Patients with serious heart problems, such as heart failure or a recent heart attack, are not eligible. Heart failure is when the heart doesn’t pump blood as well as it should, and a heart attack is when blood flow to the heart is blocked.
Patients with uncontrolled high blood pressure cannot participate. High blood pressure is when the force of the blood against the artery walls is too high.
Patients with severe liver or kidney disease are excluded. The liver and kidneys are important organs that help filter waste from the body.
Patients who are pregnant or breastfeeding cannot join the study. Pregnancy is the period during which a baby develops in the womb, and breastfeeding is feeding a baby with milk from the breast.
Patients who are unable to follow the study procedures or attend the required visits are not eligible.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Oslo Universitetssykehus HF	Oslo	Norway
University Hospital Maastricht	Maastricht	The Netherlands
Institut De Cancerologie De Lorraine	Vandoeuvre Les Nancy	France
IRCCS Humanitas Research Hospital	Rozzano	Italy
Azienda Ospedaliero Universitaria Careggi	Florence	Italy

Other Sites

Site Name	City	Country
Assistance Publique Hopitaux De Paris	Paris	France
University Hospital Galway	Galway	Ireland
Assistance Publique Hopitaux De Paris	Paris	France
University Medical Center Ljubljana	Ljubljana	Slovenia
Universitair Ziekenhuis Gent	Gent	Belgium
Deutsches Herzzentrum Berlin	Berlin	Germany
Saint Luke’s Radiation Oncology Network	Dublin	Ireland
Acschie Ufjcj Slcriomzp Lzhviw Dc Bmjfmeu	Bologna	Italy
Sqynwerzi Rdpmadc Uyxamxmupw Mkxtkpc Cwevpx	Nijmegen	The Netherlands
Ctpajcbgg Uldqajjsefihjl Syhjfvzdk	Woluwe-Saint-Lambert	Belgium
Apeoblkqj Uhh	Amsterdam	The Netherlands
Hxyza Bmrkkl Hy	Bergen	Norway
Uthlcuyfod Mvubmey Czbqxu Hvllclfsugwogvvny	Hamburg	Germany
Umjgzwyyxnptbkhmkynns Enviu Aty	Essen	Germany
Utwyzerdogtg Mrdfwtp Cpyrjcs Grqzlhluz	Groningen	The Netherlands
Ooqyucpnkjpifrmnsvbvmjvljd	Aalst	Belgium
Iyrcapgz Cihhzf Dijrrxelexuaynsch	L'hospitalet De Llobregat	Spain
Hbpffcuw Vlzd deonesqr	Barcelona	Spain
Celaxu Oybkb Lqqkasu	Lille	France

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	29.09.2023
France	Not recruiting	29.09.2023
Germany	Not recruiting	29.09.2023
Ireland	Not recruiting	29.09.2023
Italy	Not recruiting	29.09.2023
Norway	Not recruiting	29.09.2023
Slovenia	Not recruiting	29.09.2023
Spain	Not recruiting	29.09.2023
The Netherlands	Not recruiting	29.09.2023

Trial locations

Investigated drugs:

Xevinapant

Xevinapant is a medication being studied for its potential to improve treatment outcomes in older patients with a type of cancer called locally advanced head and neck squamous cell carcinoma. This medication is being tested to see if it can help patients live longer without the cancer coming back or getting worse when used alongside radiotherapy. Xevinapant works by blocking certain proteins in cancer cells that help them survive, making it easier for the radiotherapy to destroy the cancer cells.

Investigated diseases:

Squamous cell carcinoma of head and neck

Squamous cell carcinoma of head and neck – This is a type of cancer that originates in the squamous cells, which are flat cells found in the lining of the head and neck region. It typically begins in the mucous membranes of the mouth, nose, and throat. The disease progresses as the cancerous cells grow and invade surrounding tissues, potentially spreading to lymph nodes and other parts of the body. As it advances, it can cause symptoms such as a persistent sore throat, difficulty swallowing, and changes in voice. The progression can lead to the formation of tumors, which may become visible or palpable. Over time, the disease can affect the function of the affected areas, impacting speech, breathing, and eating.

Trial ID:

2022-502339-20-00

Protocol code:

EORTC 2120-HNCG

NCT ID:

NCT05724602

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Radiotherapy with Xevinapant or Placebo for Older Patients with Advanced Head and Neck Cancer

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?