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 of the oropharynx (such as the tonsil, base of tongue, throat wall, or soft palate) or an unknown primary cancer site, confirmed by biopsy or cell testing, and shown to be p16 positive or HPV positive by lab testing.
• People whose cancer shows up clearly on a PET scan (with a specific activity level of at least 4.0 on the scan, from any date or scanner).
• People whose cancer is classified as Stage I or Stage II according to standard cancer staging guidelines (AJCC 8th edition).
• People with no signs that the cancer has spread to distant parts of the body, confirmed through appropriate scans and check-ups done within the required timeframes before joining.
• People who have had a physical examination and weight recorded within 4 weeks before registration.
• For one group in the trial (Cohort B): people who have had a PET/CT scan for staging within 6 weeks before registration. For the other group (Cohort A): a diagnostic CT scan of the neck/chest or a PET-CT scan within 6 weeks before registration is acceptable.
• People with a good general health and activity level, rated 0 or 1 on the Zubrod Performance Scale (meaning fully active or able to carry out light activity), assessed within 4 weeks before registration.
• People aged 18 or older.
• People who are physically able to tolerate PET/CT imaging as required by the trial.
• For Cohort A: people whose tumour is considered potentially removable through the mouth by surgery, as determined by the treating surgeon, and who have 0 to 2 lymph nodes that appear affected on imaging.
• People with blood count results within acceptable levels, taken within 4 weeks before registration (Cohort B requires specific minimum levels for white blood cells, platelets, and haemoglobin).
• People with kidney function within normal limits or above a minimum threshold, tested within 4 weeks before registration.
• People who are willing and able to use an effective form of contraception throughout the treatment phase of the trial (applies to women who could become pregnant and to male participants).
• People who are able to provide signed informed consent before entering the trial.

Who may not be able to join:

• People whose cancer is classified as T4, N3, or M1 stage (meaning the tumour is very large, there are significant lymph node findings, or the cancer has spread to other parts of the body).
• People whose imaging shows signs that the cancer has broken through the outer wall of lymph nodes, or who have lymph nodes that appear to be clumped together in a way that suggests spread beyond the nodes.
• People who have had another invasive cancer in the past (other than certain types of non-melanoma skin cancer), unless they have been cancer-free for at least 3 years. (Note: certain non-invasive cancers such as carcinoma in situ of the breast, mouth, or cervix are generally still acceptable — confirm with trial site.)
• People who have already received any treatment for the cancer being studied in this trial.
• People who have previously had radiation therapy to the same area of the body where the study cancer is located, if that prior treatment would overlap with the radiation planned in this trial.
• People who have had a severe allergic or hypersensitivity reaction to paclitaxel, carboplatin, other platinum-based drugs, or products containing Cremophor EL (a substance used in some medicines).
• People with serious active health conditions, including: unstable chest pain or heart failure requiring hospitalisation in the past 6 months; a severe heart attack in the past 3 months; a current bacterial or fungal infection requiring intravenous antibiotics; a current severe flare-up of a lung condition (such as COPD) that would prevent participation; AIDS as defined by current health authority guidelines; liver disease causing yellowing of the skin or blood clotting problems; or severe bone marrow problems or significant bleeding.
• People who are pregnant, or women who could become pregnant and men who are sexually active but are not willing or able to use an acceptable form of contraception, as the treatments used in this trial may be harmful to an unborn child.
• For Cohort B: people with poorly controlled diabetes (fasting blood sugar above 200 mg/dL) that has not improved after two attempts to adjust fasting and medications.
• People who are currently enrolled in another clinical trial that involves active treatment for the same cancer being studied here.

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