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 aged 18 or older at the time of signing the consent form.
• People diagnosed with a specific type of throat cancer (squamous cell carcinoma of the oropharynx) that tests positive for p16 and/or HPV, affecting areas such as the base of the tongue, tonsils, soft palate, or the back wall of the throat.
• People whose cancer has been staged as early-to-intermediate (Stage I or Stage II according to AJCC 8th edition guidelines), with no more than 5 lymph nodes affected, only a small amount of cancer spread outside the lymph node covering (no more than 2mm), and with clear surgical edges of at least 2mm at the site where the cancer was removed.
• People with a general health and functioning score (called Karnofsky Performance Status) of 60 or higher, measured within 8 weeks before joining the trial.
• People whose blood test shows a certain ratio of immune cells (neutrophil-to-lymphocyte ratio) of 5 or below, measured within 8 weeks of joining.
• People with a haemoglobin level of 10 or above, measured within 8 weeks of joining (a blood transfusion to reach this level is permitted).
• People who are current non-smokers (for at least 6 months) and have a smoking history of 15 pack-years or less.
• People who are able to start radiation therapy within 8 weeks of their surgery (6 weeks is preferred).
• People who have already had the primary tumour removed through a mouth-based (transoral) surgical approach, along with removal of lymph nodes from at least the same side of the neck as the cancer.
• People who are willing and able to use adequate contraception (such as hormonal methods, barrier methods, or abstinence) before, during, and for 90 days after completing treatment. Women who become pregnant or think they may be pregnant during the trial should inform their treating doctor straight away.
• People who are able to understand the study and are willing to sign a written consent form.

Who may not be able to join:

• People whose cancer has spread along the nerves at the primary tumour site (perineural invasion).
• People whose cancer has spread into the blood vessels or lymph vessels at the primary tumour site (lymphovascular space invasion).
• People who have had cancer found in lymph nodes at a lower part of the neck (Level 4 nodes), even if those nodes have been surgically removed.
• People who have had cancer found in lymph nodes behind the throat (retropharyngeal nodes), even if those nodes have been surgically removed.
• People who still have any cancer remaining that has not been surgically removed.
• People whose cancer in the lymph nodes has grown into the surrounding neck muscles.
• People whose primary tumour was removed through a more invasive surgical approach that did not go through the mouth, such as splitting the jaw (mandibulotomy) or cutting through the side of the throat (lateral pharyngotomy).
• People who have had another cancer diagnosed within the 2 years before joining the trial — with exceptions for certain skin cancers that have been fully treated with no signs of remaining disease, or a low-grade prostate cancer (Gleason 6) that is being monitored rather than actively treated.
• People whose cancer has spread slightly outside a lymph node (extracapsular extension) but who have not had a biopsy confirming squamous cell carcinoma in a lymph node on the same side of the neck as the cancer.

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