Study on the Safety and Tolerance of Durvalumab and Radiotherapy for Patients with Untreated Head and Neck Squamous Cell Carcinoma

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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 testing a treatment that combines a medication called durvalumab (also known by its code name MEDI4736) with radiotherapy, which is a treatment that uses high-energy rays to target and kill cancer cells. The purpose of the study is to evaluate how well this combination works in controlling the cancer in the neck area without using additional radiation in areas that do not show signs of cancer.

Participants in the study will receive the treatment over a period of time, with regular check-ups to monitor their health and the cancer’s response to the treatment. The study will look at how well the treatment controls the cancer in the neck and whether it causes any side effects. The study will also assess the overall health and survival of the participants, as well as their quality of life during and after the treatment.

This trial is important for understanding the effectiveness and safety of combining durvalumab with radiotherapy for treating squamous cell carcinoma of the head and neck. The results could help improve treatment options for patients with this type of cancer in the future.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria such as age, health status, and type of cancer. The study focuses on untreated squamous cell carcinoma of the head and neck.

The patient must be over 18 years old and meet certain health conditions, including specific performance status and medical history.

2 treatment initiation

The treatment involves a combination of durvalumab and radiotherapy. Durvalumab is administered as a solution for infusion, which means it is given through a drip into a vein.

The specific dosage and frequency of durvalumab administration are determined by the medical team based on individual patient needs and study protocols.

3 radiotherapy

Radiotherapy targets the tumor site, including the primary tumor and affected lymph nodes. The treatment does not include prophylactic irradiation of unaffected neck regions.

The aim is to control the cancer locally and regionally, focusing on the neck area.

4 monitoring and follow-up

Throughout the study, the patient’s response to treatment is closely monitored. This includes assessing the control of cancer in the neck region and observing any side effects.

Regular follow-ups are scheduled to evaluate the patient’s health status and the effectiveness of the treatment. These follow-ups occur at baseline, 3, 12, and 24 months after radiotherapy.

5 study completion

The study is expected to conclude by July 2026. The primary goal is to assess the control of cancer in the neck region one year after treatment.

Secondary outcomes include evaluating side effects, overall survival, and quality of life scores.

Who Can Join the Study?

Must be over 18 years old, with no upper age limit.
Must have a Performance Status ECOG between 0 and 2. This is a scale that measures how well a person can perform daily activities.
Must have squamous cell carcinoma that has not been treated before. This is a type of cancer that affects certain cells in the body.
Must have a tumor classified as T1 to T4 with specific clinical statuses (N0-N1, N2a, or N2b) and only one affected lymph node on the same side as the tumor, as seen in imaging tests.
Must meet at least one of these fragility criteria:
- ECOG Status of 1 with multiple other health issues, at least two of which are moderate to severe (affecting kidneys, heart, blood vessels, liver, nerves, or lungs).
- ECOG Status of 2.
- Age 70 or older, considered unfit by a special geriatric evaluation or unable to receive certain chemotherapy drugs (cisplatin or carboplatin-5FU) due to specific health criteria.
The cancer must be located in the oral cavity, oropharynx, hypopharynx, or larynx.
Must have documentation of p16 disease, which is related to HPV status for tumors in the oropharynx.
Must have a glomerular filtration rate (GFR) greater than 40 mL/min/1.73m² or a calculated creatinine clearance greater than 40 mL/min. These are measures of kidney function.

Who Cannot Join the Study?

Having an untreated squamous cell carcinoma of the head and neck. This means the type of cancer in the head and neck area has not been treated yet.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Institut Gustave Roussy	Villejuif	France
Centre Radiothérapie de Blois	La Chaussée Saint Victor	France
Centre de Radiothérapie Guillaume le Conquérant	Le Havre	France
Centre Hospitalier Regional Et Universitaire De Brest	Brest	France
Centr Georges Francois Leclerc	Dijon	France

Other Sites

Site Name	City	Country
Centre Antoine Lacassagne	Nice	France
Hopital Tenon	Paris	France
Institut Sainte Catherine	Avignon	France
Centre Hospitalier Blois Simone Veil	Blois	France
Centre Paul Strauss	STRASBOURG, Alsace	France
Centre Joliot Curie	Saint-Martin-Boulogne	France
Groupe Hospitalier Bretagne Sud	Lorient	France
Hopital Beaujon	Clichy	France
Hopital Nord Franche-Comte	Belfort	France
Institut de Cancérologie de l’Ouest	Saint-Herblain	France
Centre Francois Baclesse	Caen	France
Centre De Lutte Contre Le Cancer Eugene Marquis	Rennes	France
Naurvisq Cyyxepmh daw Duginpodumpw	Valenciennes	France
Ceqtqm Oofnz Ltsnyrd	Lille	France

Trial status

Country	Status	Recruitment Start
France	Not recruiting	24.07.2024

Trial locations

Investigated drugs:

Durvalumab

Durvalumab is a medication used in this trial to help the body’s immune system fight cancer. It works by blocking a specific protein that can stop the immune system from attacking cancer cells. In this study, it is combined with radiotherapy to treat squamous cell carcinoma of the head and neck.

Radiotherapy is a treatment that uses high-energy rays to target and destroy cancer cells. In this trial, radiotherapy is directed at the tumor site, including the primary tumor and the affected lymph nodes, to help control the spread of cancer in the head and neck area.

Investigated diseases:

Squamous cell carcinoma of head and neck

Squamous Cell Carcinoma of the Head and Neck – This is a type of cancer that begins in the squamous cells, which are flat cells found in the lining of the head and neck region. It typically affects areas such as the mouth, throat, and nose. The disease progresses by forming tumors that can invade nearby tissues and spread to lymph nodes in the neck. As it advances, it may cause symptoms like a persistent sore throat, difficulty swallowing, or a lump in the neck. The progression can vary, with some cases remaining localized while others may spread to distant parts of the body. Early detection and monitoring are crucial for managing the disease’s progression.

Trial ID:

2024-513977-31-00

Protocol code:

GORTEC 2018-02

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Safety and Tolerance of Durvalumab and Radiotherapy for Patients with Untreated Head and Neck Squamous Cell Carcinoma

What is this study about?

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