Phase 2 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 who have been diagnosed with squamous cell carcinoma (a type of cancer) in the mouth, throat, voice box, or related areas in the head and neck, confirmed by a tissue or cell sample, and detected using PET, CT, or MRI scans
• People whose cancer is at Stage III, IVa, or IVb (for cancers of the mouth, lower throat, or voice box), or Stage III, IVa, or IVb oropharyngeal cancer that tests negative for p16, or Stage III oropharyngeal cancer that tests positive for p16 — based on standard cancer staging guidelines
• People who have measurable areas of cancer that can be tracked using standard imaging measurements (RECIST 1.1)
• People whose treatment plan involves radiation and chemotherapy together (without surgery) as the main treatment
• People who are planned to receive a standard type of targeted radiation therapy (IMRT) with a total planned dose of around 70 Gy
• People with a general health/activity level rated 0, 1, or 2 on the ECOG scale (ranging from fully active to limited in strenuous activity but able to carry out lighter tasks)
• People whose existing side effects from prior treatments are mild (Grade 2 or lower on a standard medical scale) and considered stable and not clinically significant at the time of screening
• People who are expected to survive for at least 20 weeks
• People who are able to follow the requirements of the trial protocol
• People who are able to understand and willing to sign a written informed consent form

Who may not be able to join:

• People who have previously had radiation treatment to the head and neck area that overlaps with the planned radiation zone, or whose prior radiation doses to sensitive organs would be exceeded, or who are known to be especially sensitive to radiation
• People with active, uncontrolled, or clinically significant physical or mental health conditions that, in the doctor's opinion, could affect their safety, ability to consent, or ability to follow the trial requirements (stable conditions managed on a steady dose may still be considered)
• People with a history of uncontrolled seizures (people with a distant history of a single triggered seizure, or well-controlled seizures on one stable medication, may still be considered — confirm with trial site)
• People who are unable to swallow a tablet and do not already have a feeding tube (NG or PEG tube) in place for medical reasons
• People whose blood test results at screening show liver enzyme levels (ALT or AST) more than 2.5 times the upper limit of normal
• People whose kidney function test shows a creatinine clearance of 50 mL/min or below
• People with a low white blood cell count (neutrophils below 1,500/µL)
• People with a low platelet count (below 100,000/µL)
• People with a low haemoglobin level (below 9 g/dL)
• People with high calcium levels in the blood (above 1.5 times the upper limit of normal)
• People with high total bilirubin levels (above 2 times the upper limit of normal)
• People with abnormal blood clotting test results (PT/INR above 1.5 times the upper limit of normal, or abnormal aPTT — confirm with trial site)
• People who test positive for hepatitis B, hepatitis C, HIV, or syphilis (RPR test)
• People who show significant abnormalities on a heart electrical activity test (ECG), such as a QTcF reading above 450 msec
• People who are receiving or planned to receive a higher-dose-per-session radiation schedule (more than 2 Gy per day)
• People with a known allergy or sensitivity to any ingredient in the trial medication
• People with a history of drug addiction in the 3 months before signing the consent form, unless a urine drug screen comes back negative before the start of the trial
• People who have taken strong medications known to significantly affect how certain liver enzymes process drugs (strong CYP3A4 or CYP2D6 inducers or inhibitors) within 14 days before the start of the trial, or within 5 times the medication's half-life, whichever is longer
• People who have received chemotherapy or other anti-cancer treatments within 14 days before the start of the trial
• People who needed intravenous (drip) antibiotics, antivirals, or antifungals for an active or uncontrolled infection at the start of the trial
• People taking sedating doses of benzodiazepine medications (such as lorazepam), though a stable low dose may be permitted
• People who have participated in another clinical trial and received a trial drug within 4 weeks before the start of this trial
• People of childbearing potential (and their partners) who are not willing to use medically accepted contraception throughout the trial and for 14 months after the last dose of cisplatin (for female participants) or 11 months (for male participants)
• People who, in the trial investigators' judgement, are otherwise not suitable to participate

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