Phase 3 Head and Neck Cancer Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• Adults aged 18 or older at the time of signing the consent form.
• People diagnosed for the first time with a specific type of head and neck cancer (squamous cell carcinoma) confirmed by a tissue sample, located in the oropharynx, larynx, or hypopharynx, at certain defined stages, and only on one side of the body without crossing the midline.
• People whose lymph nodes have been assessed using a specific type of scan (FDG-PET/CT) showing no cancer activity on the opposite side of the neck from the tumour.
• People whose treating doctor has determined that radiation therapy, with or without chemotherapy, is an appropriate treatment option for them.
• People who are generally well enough to carry out daily activities with little to no restriction (ECOG score of 0 or 1).
• People whose recent blood tests (taken within 7 days before enrolment) show that their blood cell counts, liver function, and kidney function all fall within acceptable ranges for this trial.
• People whose heart rhythm measurement (ECG) meets specific limits within 7 days before enrolment (confirm with trial site).
• Women who could become pregnant, provided a pregnancy test taken within 7 days before enrolment is negative, and who agree to use adequate contraception for up to one month after treatment ends.
• Men who are able to father children and who agree to use effective contraception during the study and for up to one month after treatment ends.
• People who are willing and able to follow the study schedule, complete required measures, and sign the informed consent form before any study procedures begin.
• People who have health insurance coverage, where this is required in their country.

Who may not be able to join:

• People whose tumour crosses the midline of the body, or who have tumours on both sides.
• People whose cancer is at a stage that does not fall within the specific categories required by this trial, including very early or very advanced stages (T4), or those with cancers spread extensively to lymph nodes or to nodes on both sides of the neck.
• People whose primary tumour size is unknown (classified as T0 in staging).
• People whose FDG-PET/CT scan shows cancer activity in lymph nodes on the opposite side of the neck from the primary tumour.
• People who have previously received any treatment for this type of head and neck cancer, including chemotherapy, radiotherapy, targeted therapy, immunotherapy, or any experimental therapy.
• People who have had another type of cancer within the past 3 years, with some exceptions such as certain treated skin cancers, cervical pre-cancers, or localised prostate cancer treated surgically with the aim of cure.
• People who are currently taking, or are expected to need, immune-suppressing medications (such as high-dose steroids, methotrexate, or similar drugs), with some limited exceptions for low-dose or locally applied steroids.
• People who are currently taking, or are expected to need, medications that stimulate the immune system, such as interferons or interleukin-2.
• People who are currently receiving another cancer treatment or taking part in another clinical trial involving a treatment.
• People with certain active infections, including a severe infection in the past 4 weeks, active hepatitis B, active hepatitis C (unless a specific blood test shows the virus is not active), HIV infection, or active tuberculosis.
• People who have psychological, cognitive, family-related, social, or geographical circumstances that may make it difficult to follow the study requirements (confirm with trial site).
• People with a known allergy or sensitivity to tretinoin (the study drug), other retinoids, soya, peanuts, or any ingredients in the study medication.
• People who have difficulty absorbing medicines through the gut, or who are unable to swallow oral medication.
• People who are currently taking or expected to need vitamin A, tetracyclines, other retinoid medicines, anti-fibrinolytic agents, or certain medications that strongly affect how the body processes the study drug (CYP3A4 inducers or inhibitors).
• Women who are pregnant or currently breastfeeding.

Important: Always verify eligibility with the trial site directly before applying.