Study on Reducing Chemoradiotherapy for HPV-Related Oropharyngeal Cancer Using Cisplatin for Patients with Squamous Cell Carcinoma

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What is this study about?

This clinical trial is focused on studying a type of throat cancer called oropharyngeal squamous cell carcinoma, which is linked to the human papillomavirus (HPV). The treatment being tested in this study is called cisplatin, a medication that is given through a vein in the arm. The purpose of the study is to see if reducing the intensity of the usual treatment, which combines chemotherapy and radiation, can still effectively control the cancer over two years while minimizing side effects.

Participants in the study will receive a treatment plan that involves the use of cisplatin over a period of time. The study will monitor how well the cancer is controlled locally, meaning in the area where it started, and will also look at any side effects that occur. The study aims to find out if this adjusted treatment approach can maintain control over the cancer and improve the quality of life for patients.

Throughout the study, researchers will also gather information on overall survival rates, survival without the disease, and any spread of the cancer to other parts of the body. They will also examine the reliability of a specific biomarker called p16, which is used to help identify this type of cancer. The study will compare results between people who smoke and those who do not, to see if there are differences in how the cancer behaves. The study is expected to continue until 2029.

1 joining the study

Upon joining the study, the patient must meet specific criteria, including having oropharyngeal squamous cell carcinoma associated with human papillomavirus (HPV).

The patient must be at least 18 years old, with adequate blood counts and renal function, and must not exceed a lifetime smoking history of 20 pack-years.

2 treatment initiation

The treatment involves the administration of cisplatin, a chemotherapy drug, given through an intravenous route.

The therapy is designed to last for one week, with the aim of de-escalating the primary chemoradiotherapy.

3 monitoring and assessment

Throughout the trial, the effectiveness of the treatment in controlling the disease locally for two years will be assessed.

The prevalence of late side effects will also be evaluated using specific criteria.

4 follow-up and outcomes

The primary outcome is the control of the disease in the local region over two years.

Secondary outcomes include overall survival, disease-specific survival, and the impact on quality of life.

Who Can Join the Study?

Have a type of cancer called oropharyngeal squamous cell carcinoma.
Have a certain level of neutrophils (a type of white blood cell) that is at least 1.5 x 10^9 per liter.
Have adequate kidney function to handle a one-week therapy with a drug called cisplatin.
Have levels of bilirubin, AST, or ALT (liver enzymes) that are no more than three times the normal upper limit.
Have a negative pregnancy test if applicable.
Have signed an informed consent form, which means you understand and agree to participate in the study.
Be able to speak the Slovak language.
Have a positive result for p16 by a test called immunohistochemistry, which is used to check for certain proteins in cancer cells.
Have a clinical stage of T1-T2, N1-N2c or T3, N2-N2c according to the UICC 8th edition, and no cancer spread to distant parts of the body.
Have a lifetime smoking history that does not exceed 20 pack-years (a way to measure how much someone has smoked over time).
Have a WHO status of 0-1, which means you are fully active or have some symptoms but can still do light work.
Be at least 18 years old.
Be of any gender.
Have a hemoglobin level of at least 10 grams per liter, which is important for carrying oxygen in the blood.
Have a platelet count of at least 100 x 10^9 per liter, which is important for blood clotting.

Who Cannot Join the Study?

Patients who have a different type of cancer than the one being studied.
Patients who have had previous treatments that might interfere with the study results.
Patients with other serious health conditions that could affect their safety during the trial.
Patients who are unable to follow the study procedures or attend required visits.
Patients who are pregnant or breastfeeding.
Patients who are participating in another clinical trial at the same time.
Patients who have allergies to the study medication or its ingredients.
Patients who have a history of substance abuse that could affect their participation.
Patients who have certain infections that could impact the study.
Patients who are not able to give informed consent, which means they cannot understand and agree to the study details.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Vychodoslovensky Onkologicky Ustav a.s.	Kosice	Slovakia

Trial status

Country	Status	Recruitment Start
Slovakia	Not recruiting	09.01.2020

Trial locations

Investigated drugs:

Cisplatin

Cisplatin is a chemotherapy medication used in the treatment of various types of cancer, including squamous cell carcinoma of the oropharynx. It works by interfering with the DNA in cancer cells, preventing them from growing and dividing. In this trial, it is used as part of the chemoradiotherapy regimen to help control the cancer.

Radiotherapy is a treatment that uses high doses of radiation to kill cancer cells and shrink tumors. In this trial, radiotherapy is combined with chemotherapy to enhance the effectiveness of the treatment for squamous cell carcinoma of the oropharynx associated with human papilloma virus (HPV). The goal is to control the disease locally and reduce the risk of recurrence.

Human Papillomavirus oropharyngeal squamous cell carcinoma – This is a type of cancer that occurs in the oropharynx, which is the middle part of the throat, including the back of the tongue, tonsils, and walls of the throat. It is associated with infection by the human papillomavirus (HPV), a common virus that can lead to cancerous changes in cells. The disease typically begins with the development of abnormal cells in the oropharynx, which can grow and form tumors. As the cancer progresses, it may spread to nearby tissues and lymph nodes. Symptoms can include a persistent sore throat, difficulty swallowing, and changes in voice. The progression of the disease can vary, with some cases remaining localized while others may spread to distant parts of the body.

Trial ID:

2024-517832-23-00

Protocol code:

NADEJ201901

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Reducing Chemoradiotherapy for HPV-Related Oropharyngeal Cancer Using Cisplatin for Patients with Squamous Cell Carcinoma

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?