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 who have been diagnosed (confirmed by tissue or cell testing) with squamous cell carcinoma (a type of cancer) in the mouth area — this includes the tongue, floor of the mouth, inner lip, inner cheek, lower or upper gum ridge, the area behind the back molars, or the roof of the mouth
• People whose cancer is at an early stage (T1 or T2, with no spread to lymph nodes or distant parts of the body, based on standard staging guidelines), confirmed by a physical examination and head/neck and chest imaging done within the past 42 days
• People who a surgeon has assessed as suitable for a specific type of surgery involving removal of the main tumour through the mouth and a lymph node procedure in the neck, all done within the past 42 days
• People aged 18 or older
• People with a general health and activity level that falls within an acceptable range (confirmed by assessment within the past 42 days)
• Women who could become pregnant must have had a negative pregnancy test (blood or urine) within the past 42 days
• People who are able to read and understand English or French (required because a key questionnaire used in this trial is only available in those two languages)
• People who have completed a specific quality-of-life questionnaire (called the NDII) before moving to the next stage of the trial
• People whose PET/CT scan (a type of imaging scan done before the second stage of the trial) shows no cancer in the lymph nodes, as confirmed by a central review team
• People (or their legal representative) who have given written consent to participate in the study

Who may not be able to join:

• People whose cancer has already clearly spread to lymph nodes in the neck or to other parts of the body
• People who have had another type of invasive cancer (not counting certain treated skin cancers or early-stage breast or cervical conditions) unless they have been cancer-free for at least 2 years
• People whose squamous cell carcinoma is located in other parts of the throat or voice box area (such as the oropharynx, nasopharynx, hypopharynx, or larynx) rather than the mouth
• People who are unwilling or unable to complete the required questionnaire
• People who have previously received chemotherapy specifically for this mouth cancer (prior chemotherapy for a different cancer may be acceptable — confirm with trial site)
• People who have had radiation therapy to the same area of the body in a way that would overlap with any future radiation treatment
• People with serious ongoing health conditions that would make neck surgery too risky
• People who are pregnant or breastfeeding
• People whose mouth cancer was not fully removed, leaving a positive (cancerous) margin after surgery — though a prior biopsy-style removal is acceptable
• People who have had prior surgery to the side of the neck (such as a previous neck dissection or a serious neck injury that would prevent further surgery in that area) — prior thyroid surgery or a simple biopsy may be acceptable (confirm with trial site)
• People with a known history of blood cancers (such as certain types of leukaemia) or other active conditions known to cause enlarged lymph nodes (such as sarcoidosis or untreated tuberculosis-type infections)
• People currently receiving chemotherapy, immunosuppressive medicines, or other treatments that affect the immune system
• People currently taking part in another clinical trial involving an experimental treatment

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