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:

• People who have been diagnosed with squamous cell carcinoma (a type of cancer) of the oropharynx — this includes cancers of the tonsil, base of tongue, soft palate, or back wall of the throat, confirmed by a tissue or cell sample.
• People whose tissue sample has tested positive for a protein called p16 (found in more than 70% of the sample cells), which is a marker linked to HPV-related cancers.
• People who have a detectable level of HPV DNA in their blood at the time of screening (measured by a specific test called the Naveris test).
• People whose cancer is at a stage classified as T1–T3, N1–N2b (using the AJCC 7th Edition staging system), with no sign that the cancer has spread to distant parts of the body (confirm with trial site for what this means for a specific case).
• People who have had a throat examination using a small camera or mirror within 8 weeks before joining the trial.
• People who have had appropriate imaging scans — either a CT scan or MRI of the neck (with contrast dye), combined with a PET/CT scan of the neck and chest — within 8 weeks before joining.
• People who have a personal smoking history of 10 pack-years or fewer. A pack-year is calculated by multiplying the number of packs of cigarettes smoked per day by the number of years smoked (cigars and pipes are not counted in this calculation).
• People who are reasonably active and able to care for themselves, rated 0 or 1 on the Zubrod Performance Scale (a medical measure of general wellbeing), within 8 weeks before joining.
• People with blood test results showing adequate blood cell counts and blood health, taken within 2 weeks before joining (confirm with trial site for specific values).
• People with adequate kidney function, measured by a blood or urine test within 2 weeks before joining (confirm with trial site for specific values).
• Women who could potentially become pregnant must have a negative pregnancy blood test within 14 days before joining.
• People who are HIV-positive may still be considered eligible, provided they have never had an AIDS-defining illness, have a CD4 immune cell count of at least 350 cells/mm³, do not have drug-resistant HIV, and do not also have hepatitis B or hepatitis C infections. People who have been vaccinated against hepatitis B and show immunity may still be considered eligible.
• People who are willing and able to give informed consent to take part in the study before joining.

Who may not be able to join:

• People whose blood test shows no detectable HPV DNA at the start of the trial.
• People whose cancer originated in the oral cavity (such as the tongue, floor of the mouth, gums, cheeks, or lips), the nasopharynx, hypopharynx, or larynx, even if the cancer tests positive for p16.
• People with a cancer in the neck where no primary (original) tumour site can be identified, even if p16 positive.
• People whose cancer has spread to distant parts of the body, or to lymph nodes below the collarbone.
• People who have already had all visible cancer removed through surgery — including tonsil removal, removal of the primary tumour, or removal of all affected lymph nodes.
• People who have two separate primary cancers occurring at the same time, or cancers on both sides of the body.
• People who have had another cancer in the past, unless they have been free of that cancer for at least 3 years. Some non-invasive cancers (such as certain early-stage cancers of the breast, mouth, or cervix) may still be permitted (confirm with trial site).
• People who have previously received chemotherapy specifically for this cancer. Prior chemotherapy for a different cancer may be acceptable.
• People who have previously had radiation therapy to the same area of the body in a way that would overlap with the radiation planned in this trial.
• People with serious ongoing health conditions, including: unstable chest pain or heart failure requiring hospitalisation in the past 6 months; a major heart attack in the past 6 months; an active serious bacterial or fungal infection being treated with intravenous antibiotics at the time of joining; a severe flare-up of a lung condition or other breathing problem requiring hospitalisation within 30 days of joining; serious liver disease causing visible jaundice or blood clotting problems; or AIDS with significant immune system damage (confirm with trial site for specific definition).
• People who are currently pregnant, as the treatment may be harmful to an unborn baby.
• People who have had a severe allergic reaction to the chemotherapy drug cisplatin in the past.
• People who cannot safely have an MRI scan, including those with certain metal implants (such as pacemakers, surgical clips, artificial valves, or metal fragments in the body), metal jewellery or clothing clips that cannot be removed, a fear of enclosed spaces (claustrophobia), or a history of seizures.
• People with very poor kidney function (GFR below 15 ml/min/1.73m²) or who are on dialysis will not receive the contrast-enhanced MRI scan, but may still receive a standard MRI without contrast (confirm with trial site).

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