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:

• You are generally healthy and able to carry out daily activities with little or no limitation (your doctor may refer to this as ECOG performance status 0 or 1).
• You have been newly diagnosed with a confirmed squamous cell cancer (a specific type of cancer) of the mouth, throat, voice box, or lower throat area, and it has been classified as an advanced stage (Stage III or IV).
• You have completed one of the following treatments: surgery followed by radiation or combined radiation and chemotherapy; pre-treatment therapy followed by radiation or combined radiation and chemotherapy; or combined radiation and chemotherapy alone.
• If you had surgery, your radiation treatment started between 4 and 8 weeks after your surgery was completed.
• You are enrolling between 4 and 8 weeks after your last radiation treatment was finished.
• There is no sign that your cancer is still active in the treated area or has spread to other parts of your body before joining the trial.
• Your blood counts, liver function, and kidney function are all within acceptable levels (your doctor will check this with blood tests).
• You are willing to be informed about the research nature of the study and sign a consent form agreeing to take part.

Who may not be able to join:

• Your cancer tests positive for a protein called p16 (confirm with trial site).
• You are known to be unable to tolerate or are allergic to a drug called capecitabine.
• You have a condition that makes it difficult to take medication by mouth, such as trouble swallowing, ongoing severe diarrhea, or a bowel blockage.
• You have had a previous cancer, unless it was an early-stage skin cancer or a non-spreading cervical condition that has already been successfully treated.
• You are currently pregnant or breastfeeding (women who could become pregnant will be asked to take a pregnancy test and to use effective contraception during the trial).
• You received surgery, chemotherapy, radiation, or other cancer treatments to the affected area before your main course of treatment (diagnostic procedures do not count).
• You received surgery, biological therapy, or immunotherapy at the same time as your radiation treatment.
• You are currently receiving, or are very likely to receive, other chemotherapy, biological therapy, or immunotherapy after your radiation treatment has finished.
• You have another serious ongoing health condition that could put you at unacceptable risk or make it hard to follow the trial requirements — for example, unstable heart disease, kidney disease, chronic hepatitis, poorly controlled diabetes, or significant emotional or mental health difficulties.

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