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Study Comparing Cisplatin and Radiotherapy with Durvalumab and Radiotherapy for Patients with Intermediate Risk HPV-Positive Oropharyngeal Cancer

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What is this study about?

This clinical trial is focused on studying a type of cancer called Oropharyngeal Squamous Cell Carcinoma, which affects the throat area. The study is specifically looking at cases that are linked to a virus known as HPV (Human Papillomavirus) and are considered to be at an intermediate risk level. The trial is comparing different treatment combinations to see which is more effective in preventing the cancer from coming back or spreading. The treatments being tested include a drug called Durvalumab, another drug called Cisplatin, and a treatment method called radiotherapy, which uses high-energy rays to target and kill cancer cells.

The purpose of the study is to evaluate how well these treatments work in terms of event-free survival, which means the length of time patients remain free from certain negative events related to their cancer. Participants in the study will receive one of the following treatment plans: radiotherapy combined with Cisplatin, radiotherapy combined with Durvalumab followed by additional Durvalumab, or radiotherapy combined with Durvalumab followed by a combination of Tremelimumab and Durvalumab. The study will monitor patients over a period to assess the effectiveness and safety of these treatments.

Throughout the study, participants will undergo regular check-ups and assessments to track their health and the progress of their treatment. The study aims to provide valuable information that could help improve treatment options for patients with this type of cancer in the future. The trial is expected to continue until 2026, allowing researchers to gather comprehensive data on the long-term effects and benefits of the treatments being tested.

1 randomization

Upon joining the study, the patient is randomly assigned to one of the treatment groups. This process is called randomization and ensures that each patient has an equal chance of receiving any of the treatment options being studied.

2 treatment group assignment

The patient is assigned to one of the following treatment groups: (A) cisplatin plus radiotherapy, or (B) durvalumab plus radiotherapy followed by additional durvalumab treatment.

3 treatment initiation

Treatment begins within one week of randomization. The patient receives either cisplatin or durvalumab, depending on the assigned group, in combination with radiotherapy.

4 cisplatin administration

For patients in the cisplatin group, the medication is administered intravenously as a solution for infusion. The specific dosage and frequency are determined by the medical team based on the patient’s condition.

5 durvalumab administration

For patients in the durvalumab group, the medication is also administered intravenously as a solution for infusion. The treatment continues with additional doses of durvalumab after the initial combination with radiotherapy.

6 follow-up and monitoring

Throughout the trial, the patient’s health and response to treatment are closely monitored. This includes regular medical assessments and imaging tests to evaluate the effectiveness of the treatment and to check for any side effects.

7 completion of treatment

The treatment phase concludes as per the study protocol. The patient continues to be monitored for event-free survival, overall survival, and quality of life, among other outcomes.

Who Can Join the Study?

  • The patient must have a confirmed diagnosis of squamous cell carcinoma of the oropharynx, which is a type of cancer in the throat area, and it must be locally advanced but not spread to other parts of the body.
  • The patient must be able and willing to complete questionnaires about their quality of life and health in the languages provided.
  • The patient must be available for treatment and follow-up appointments.
  • The treatment must start within one week after the patient is randomly assigned to a treatment group.
  • The patient must not be receiving any other anti-cancer treatment in another clinical study and must agree not to join other studies while participating in this trial.
  • The patient must have normal functioning of organs and bone marrow, as defined in the study protocol, checked within 14 days before starting the study.
  • The patient must give written consent to participate in the study, following local and regulatory requirements.
  • The patient must be evaluated by cancer specialists and deemed suitable for the study treatments, which include radiotherapy, cisplatin, and durvalumab.
  • The cancer must be related to human papillomavirus (HPV), confirmed by a specific test showing positive results in a significant portion of the tumor cells.
  • The patient must have a performance status of 0 or 1, which means they are fully active or have some symptoms but can carry out light work, and must weigh more than 30 kg.
  • The patient must be 18 years of age or older.
  • Certain imaging tests, like CT or MRI scans, must be done within 8 weeks before starting the study.
  • Women and men who can have children must agree to use effective birth control methods during the study and for a specified time after the study treatments.
  • Women who can have children will have a pregnancy test before starting the study and regularly during the study and for a period after the study treatments.
  • The patient must agree to provide tissue samples for the study.
  • The patient must agree to provide samples of blood, saliva, and a swab from the throat area.

Who Cannot Join the Study?

  • Patients who have a different type of cancer than the one being studied.
  • Patients who have had previous treatment for their cancer that is not allowed in the study.
  • Patients with other serious health conditions that could affect their safety or the study results.
  • Patients who are pregnant or breastfeeding.
  • Patients who are unable to follow the study procedures or attend study visits.
  • Patients who are participating in another clinical trial at the same time.
  • Patients who have allergies to the study medications.
  • Patients who have an active infection that requires treatment.
  • Patients who have a history of certain heart problems.
  • Patients who have a history of certain lung problems.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Katholieke Universiteit te Leuven Leuven Belgium

Other Sites

Site Name City Country Status
Universitair Ziekenhuis Gent Gent Belgium
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur Namur Belgium
Gasthuiszusters Antwerpen Antwerp Belgium
Fondazione I.R.C.C.S. Istituto Neurologico Besta Milan Italy
Calhakloc Ucavfwpqvqwiga Scdyxuaru Woluwe-Saint-Lambert Belgium
Iqanxkhz Cxiyzv Dheujihwsdzbocitk L'hospitalet De Llobregat Spain
Hbtpgulf Vlvp debfenjz Barcelona Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
28.05.2018
Italy Italy
Not recruiting
28.05.2018
Spain Spain
Not recruiting
28.05.2018

Trial locations

Investigated drugs:

Cisplatin is a chemotherapy medication used in this trial to treat cancer. It works by damaging the DNA of cancer cells, which prevents them from dividing and growing. In this study, it is combined with radiotherapy to enhance its effectiveness against oropharyngeal squamous cell cancer.

Durvalumab is an immunotherapy drug that helps the immune system recognize and attack cancer cells. It is used in this trial in combination with radiotherapy and also as an additional treatment after the initial therapy to help prevent the cancer from returning.

Tremelimumab is another immunotherapy medication that is being tested in this trial. It works by stimulating the immune system to fight cancer cells. In this study, it is used after the initial treatment with durvalumab and radiotherapy to see if it can further improve the outcomes for patients.

Oropharyngeal Squamous Cell Carcinoma – This is a type of cancer that occurs in the oropharynx, which is the middle part of the throat. It typically begins in the squamous cells, which are flat cells lining the throat. The disease often progresses by growing locally in the throat and can spread to nearby lymph nodes. It is associated with risk factors such as smoking, alcohol use, and infection with human papillomavirus (HPV). As the cancer advances, it may cause symptoms like a sore throat, difficulty swallowing, or a lump in the neck. Early detection and monitoring are crucial for managing its progression.

Trial ID:
2023-508853-13-00
Protocol code:
EORTC 1740-HNCG
NCT ID:
NCT03410615
Trial Phase:
Therapeutic exploratory (Phase II)

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