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Study Comparing Two Cisplatin Dosing Schedules with Radiation for Patients with Advanced Head and Neck Cancer

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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 treatments for advanced head and neck cancer, specifically a type called squamous cell carcinoma. The study is comparing two different schedules of a chemotherapy drug called cisplatin, which is used in combination with radiation therapy. Cisplatin is given as a solution through an infusion, which means it is delivered directly into the bloodstream through a vein. The trial will compare giving cisplatin every three weeks at a higher dose of 100 mg/m² to giving it weekly at a lower dose of 40 mg/m².

The purpose of the study is to determine if the weekly schedule of cisplatin is better in terms of reducing side effects, known as acute toxicity, compared to the three-week schedule. Additionally, the study aims to see if the weekly schedule is just as effective in terms of overall survival, which means how long patients live after starting treatment. The trial will also look at other outcomes, such as the cancer's response to treatment and any long-term side effects.

Participants in the study will receive either the weekly or the three-week cisplatin treatment along with radiation therapy. The study will monitor patients over time to assess the effectiveness and safety of the treatments. This research is important for finding the best way to treat advanced head and neck cancer while minimizing side effects for patients.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial treatment phase
The treatment involves the use of cisplatin, a medication administered through an intravenous infusion. This means the medication is given directly into a vein.
There are two different dosing schedules for cisplatin in this study. One group receives 100 mg/m² every three weeks, while the other group receives 40 mg/m² weekly. The specific schedule will be determined at the start of the trial.
Step 2
Radiation therapy
Radiation therapy is combined with cisplatin treatment. This therapy uses high-energy rays to target and destroy cancer cells in the head and neck area.
The duration and frequency of radiation therapy will align with the cisplatin dosing schedule assigned.
Step 3
Monitoring and assessment
Throughout the trial, regular monitoring will occur to assess the body's response to treatment. This includes evaluating any side effects and the effectiveness of the therapy.
Assessments will focus on measuring acute toxicity, overall survival, and other health outcomes such as quality of life and hearing.
Step 4
Follow-up phase
After completing the treatment phase, follow-up visits will be scheduled to continue monitoring health status and any long-term effects of the treatment.
These visits will help in understanding the progression-free survival and any late toxicity effects.

Who can join the trial?

13 criteria

Must have a confirmed diagnosis of squamous cell carcinoma of the head and neck, which is a type of cancer affecting areas like the throat, voice box, or nearby regions.
Can have another cancer, as long as it doesn't affect the safety or effectiveness of the study treatment.
If able to become pregnant, must have a negative pregnancy test within 14 days before joining the study.
Must agree to use highly effective birth control methods during the study and for a period after the last dose of the study drug: 14 months for females and 11 months for males.
Must provide informed consent, which means agreeing to participate after understanding the study details.
Must have visible or detectable cancer at the main site or in nearby lymph nodes.
Must be at a specific stage of cancer, with no spread to distant parts of the body.
Must be 18 years of age or older.
Must have a Zubrod (ECOG) performance status of 0-1, which means being fully active or restricted in physically strenuous activity but able to carry out light work, within 14 days before joining the study.
Must have adequate blood health, as defined in the study, within 30 days before joining.
Must have adequate kidney health, as defined in the study, within 30 days before joining.
Must have adequate liver health, with specific limits on liver function tests, within 30 days before joining. This does not apply to those with known Gilbert's syndrome, a mild liver condition.
Patients with HIV who are on effective treatment, have an undetectable viral load within 6 months, and a CD4 T Cell count greater than 200 cells/mm³ can join. HIV testing is not required to enter the study.

Who cannot join the trial?

7 criteria

Patients who have a different type of cancer than advanced head and neck cancer cannot participate.
Individuals who are not within the specified age range for the study are excluded.
Patients who are not able to receive the specific treatment being tested, which involves radiation and a drug called cisplatin, are not eligible.
People who have other serious health conditions that might interfere with the study treatment are excluded.
Individuals who are pregnant or breastfeeding cannot take part in the study.
Patients who have participated in another clinical trial recently may not be eligible.
Those who are unable to follow the study procedures or attend regular appointments are excluded.

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Verified sites

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University Hospital Galway
Galway, Ireland

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Investigated drugs

Cisplatin
This medication is used in the trial to treat patients with advanced squamous cell carcinoma of the head and neck. It is a type of chemotherapy that helps to stop the growth of cancer cells. In this study, cisplatin is given to patients in two different schedules: either every three weeks or weekly, in combination with radiation therapy. The trial aims to compare the effectiveness and side effects of these two treatment schedules.
Radiation Therapy
This treatment uses high-energy rays to target and kill cancer cells. In the trial, radiation therapy is combined with cisplatin to treat patients with advanced squamous cell carcinoma of the head and neck. The study is investigating whether the combination of radiation with weekly cisplatin is as effective as, or better than, the combination with cisplatin given every three weeks.

Cisplatin

What is already known about the treatment

Cisplatin – Cisplatin is administered intravenously and is used in combination with radiation therapy for treating advanced head and neck cancer. It is currently well-established in medical practice and literature as a chemotherapy agent. The main therapeutic indication for cisplatin in this context is locoregionally advanced squamous cell carcinoma of the head and neck. At the molecular level, cisplatin works by binding to DNA in cancer cells, causing cross-linking and ultimately leading to cell death. It is classified as a platinum-based chemotherapy drug.

Investigated diseases

Advanced Head and Neck Cancer – This disease refers to a group of cancers that originate in the squamous cells lining the moist surfaces inside the head and neck, such as the mouth, throat, and nose. It is characterized by the uncontrolled growth of abnormal cells in these areas, which can form tumors. As the disease progresses, it may spread to nearby tissues and lymph nodes, and in some cases, to distant parts of the body. Symptoms often include persistent sore throat, difficulty swallowing, and changes in voice. The progression of the disease can lead to significant impacts on speech, breathing, and overall quality of life. Early detection and management are crucial to controlling the spread and impact of the disease.