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Study of Nimorazole Treatment Based on Hypoxia Profile in Head and Neck Cancer Patients Receiving Radiotherapy with Cisplatin

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on patients with Head and Neck Squamous Cell Carcinoma, a type of cancer that develops in the tissues of the head and neck region. The research examines the effectiveness of a treatment combination using two medications: nimorazole tablets and cisplatin. Nimorazole is a drug that modifies oxygen levels in cancer cells, while cisplatin is a chemotherapy medication given through infusion.

The purpose of this research is to determine if patients whose tumors show specific genetic patterns related to oxygen levels can achieve similar treatment outcomes whether they receive nimorazole or not during their radiation therapy. The study uses genetic testing to examine tumor characteristics before treatment begins. Patients will receive radiation therapy, and some will also receive nimorazole tablets and cisplatin infusions as part of their treatment.

During the treatment period, which lasts up to 6 months, patients may receive up to 3,500 mg of nimorazole per day and up to 40 mg/m² of cisplatin. The total amount of nimorazole that may be given throughout the entire treatment period is up to 75,000 mg, while the total amount of cisplatin may reach 70 mg. Doctors will monitor how well the cancer responds to the treatment and track any side effects that may occur.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial treatment preparation
Your doctor will confirm you have head and neck squamous cell carcinoma (HNSCC), which is a type of head and neck cancer
A gene profile test will be performed to determine your tumor's hypoxic status (oxygen level in the tumor tissue)
The test results must be available before starting radiotherapy
Step 2
Treatment assignment
Based on your gene profile test results, you will be randomly assigned to one of two treatment groups
Your radiotherapy treatment will start within 3 weeks of joining the study
Step 3
Treatment period
You will receive radiotherapy as your main treatment
Depending on your assigned group, you may receive Nimoral tablets (nimorazole) 500 mg taken by mouth
You may also receive cisplatin through an infusion into your vein
The treatment will continue according to your personalized treatment plan
Step 4
Follow-up period
Your doctor will monitor your response to treatment
Regular check-ups will assess:
- Cancer control in the treated area
- Any spread of cancer to other parts of the body
- Your overall health and recovery
- Any side effects from the treatment
Step 5
Long-term monitoring
The study will continue monitoring patients until December 2029
Your doctor will assess both early and late effects of the treatment
Regular evaluations will track your recovery and cancer status

Who can join the trial?

8 criteria

Diagnosed with head and neck squamous cell carcinoma (HNSCC) requiring treatment with radiation therapy and nimorazole (a medication that helps make radiation therapy more effective)
Must be able to start radiation therapy within 3 weeks of joining the study
Must have results from a hypoxic gene profile test (a test that measures oxygen levels in tumor cells) available before starting radiation therapy
No other current cancer diagnoses or previous cancer that could affect the treatment or results of this study
Must be an adult (18 years or older)
Can be either male or female
Must be able to understand and sign an informed consent form
Must follow treatment guidelines as established by DAHANCA (Danish Head and Neck Cancer Group)

Who cannot join the trial?

15 criteria

Age below 18 years or above 75 years
Patients with any type of cancer other than head and neck squamous cell carcinoma (HNSCC)
Pregnant or breastfeeding women
Previous treatment with radiation therapy to the head and neck area
Active infections that require systemic treatment
Serious heart conditions or uncontrolled high blood pressure
Severe kidney or liver problems
History of allergic reactions to similar medications
Mental conditions that prevent understanding of the trial requirements
Participation in other clinical trials within the last 30 days
Inability to take oral medications
Any condition that could interfere with the regular treatment schedule
History of another cancer in the past 5 years (except for successfully treated non-melanoma skin cancer)
Unstable medical conditions that require frequent medication changes
Use of medications that could interact with the study treatment

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Helse Bergen HF
Bergen, Norway
Verified
Herlev Hospital
Herlev, Denmark
Responsive
Region Midtjylland
Aarhus, Denmark

Trial locations

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Investigated drugs

Nimorazole
is a medication that helps make cancer cells more sensitive to radiation therapy. It works by targeting areas of low oxygen (hypoxic areas) in tumors. When combined with radiation therapy, it helps improve the effectiveness of treatment for head and neck cancer patients. The medication is taken during the course of radiation therapy to enhance treatment outcomes.
Radiation therapy
is a treatment that uses high-energy beams to target and destroy cancer cells in the head and neck area. It is the primary treatment in this trial, and it's delivered in carefully planned doses over several weeks to kill cancer cells while trying to minimize damage to healthy tissue.

What is already known about the treatment

Nimorazole - A radiosensitizing drug administered orally as tablets during radiation therapy for head and neck cancer treatment. This medication works by making oxygen-deprived (hypoxic) cancer cells more sensitive to radiation therapy, thereby improving the effectiveness of the treatment. Nimorazole belongs to the class of hypoxic cell sensitizers and is particularly used in the treatment of head and neck squamous cell carcinoma (HNSCC) in conjunction with radiotherapy. The drug's mechanism of action involves mimicking oxygen in low-oxygen tumor environments, which enhances the DNA-damaging effects of radiation therapy on cancer cells.

Investigated diseases

Head and Neck Squamous Cell Carcinoma (HNSCC) - A cancer that begins in the flat squamous cells that make up the thin layer of tissue on the surface of the head and neck structures. This cancer can develop in the mouth, nose, throat, larynx (voice box), sinuses, or salivary glands. The disease typically starts when cells in the squamous layer begin to grow uncontrollably. As the cancer progresses, it can spread deeper into nearby tissues and may form a tumor mass. HNSCC commonly affects people who have a history of tobacco use or frequent alcohol consumption. The condition can also be linked to human papillomavirus (HPV) infection, particularly in cases affecting the throat area.