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:

• People aged 18 to 69 years old
• People who have been diagnosed with a specific type of mouth cancer (called squamous cell carcinoma) at stages pT1 through pT4, confirmed by a tissue test, and who are having surgery to remove the cancer along with lymph nodes in the neck
• People whose cancer has certain high-risk features, such as cancer cells found at or very close to the edge of the removed tissue (5mm or less), cancer that has spread into nearby blood vessels or nerves, or a tumour classified as pT3 or pT4
• People who have had enough lymph nodes removed from at least one side of the neck (at least 12 nodes from one side)
• People whose cancer has not spread extensively to the lymph nodes (classified as N0 or N1) but who have high-risk features and are having radiation therapy after surgery for mouth cancer
• People who have had a specific tissue risk assessment called the Brandwein-Gensler (BG) histological risk assessment completed
• People with a general health and functioning score of 70 or above on the Karnofsky scale (confirm with trial site)
• People who are able to complete quality-of-life questionnaires in English or Hindi
• People whose radiation treatment after surgery can begin within around 6 to 8 weeks of surgery
• People who have given written consent to participate in treatment
• People who are able to attend long-term follow-up appointments

Who may not be able to join:

• People whose cancer is not the squamous cell type
• People whose cancer has spread to other parts of the body (distant metastases)
• People with early-stage cancer (pT1–2) that does not have any high-risk features
• People whose cancer has spread significantly to the lymph nodes (classified as N2 or N3)
• People who need radiation therapy because their cancer has come back and they have been irradiated before
• People who did not have enough lymph nodes removed during surgery (fewer than 12 nodes examined)
• People whose tumour is very close to the midline of the mouth (within 1 cm) and who only had lymph nodes removed from one side of the neck
• People for whom radiation treatment after surgery would begin more than 8 weeks after surgery
• People who have previously had radiation therapy to the head or neck area
• People who have had another cancer (other than certain non-melanoma skin cancers or early-stage cervical cancer) within the past 2 years
• People under 18 or over 70 years of age
• People who have not had the Brandwein-Gensler (BG) histological risk assessment completed

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