Surgery and Reducing Ionizing Radiation of the Unknown Primary

Launched by LONDON HEALTH SCIENCES CENTRE RESEARCH INSTITUTE OR LAWSON RESEARCH INSTITUTE OF ST. JOSEPH'S · Aug 28, 2024

Keywords

ClinConnect Summary

The SUPERIOR trial is studying the best ways to treat certain types of head and neck cancer, particularly when doctors can't find the original tumor but see cancer in the lymph nodes. This often happens in patients with HPV-positive cancers, which tend to have a good survival rate. The trial aims to find out if reducing the amount of radiation given during treatment can still be effective in treating the cancer while also helping patients avoid side effects like difficulty swallowing and dry mouth. Researchers are also looking into whether surgery alone might be enough for some patients instead of combining surgery with radiation.

To be eligible for the trial, participants should be at least 18 years old and have a specific type of cancer that meets certain criteria, such as having positive tests for a marker called p16 and no evidence of the original tumor after thorough medical exams. Participants will undergo surgeries and possibly receive less radiation than usual, depending on their specific situation. The trial is not yet recruiting, but it aims to help improve treatment outcomes and quality of life for those dealing with this type of cancer.

Gender

ALL

Eligibility criteria

• • Inclusion criteria for the Registration phase
• • p16 positive PUK SCC of the neck
• • Age 18 years or older
• • Willing to provide informed consent
• • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
• • Clinical nodal stage N1, AJCC 8th edition (i.e. clinical unilateral nodal disease, none larger than 6 cm)
• • Complete clinical work-up, including CT neck, physical examination with nasopharyngoscopy, and PET/CT, with no evidence of a primary tumor. The PET/CT scan must be without focal metabolic activity concerning for a primary tumor, in the opinion of the nuclear medicine physician. Metabolic activity, particularly in the tonsils and base of the tongue which is within normal physiologic range, does not exclude participation.
• • Inclusion criteria for the Randomization phase
• • Completed ipsilateral tonsillectomy and base of tongue mucosectomy with no evidence of a primary tumor
• • o Note, patients who had a PET/CT that was initially positive, and therefore not meeting criteria in 4.10, but panendoscopy with biopsies of the fluorodeoxyglucose (FDG)-avid areas do not show malignancy, can then be enrolled and would be returned the OR for a neck dissection prior to randomization
• • Ipsilateral nodal disease on pathology with no evidence of extranodal extension
• Exclusion Criteria:
• • Radiological or pathological extra-nodal extension
• • Epstein-Barr Virus (EBV)-positive
• • Clinical nodal stage (i.e. before neck dissection) N2-3, AJCC 8th edition (ie. bilateral nodes or node \>6cm)
• • Pathological nodal stage (i.e. after neck dissection) pN3
• • Prior history of head and neck cancer within 2 years
• • Any other active invasive malignancy, except non-melanotic skin cancers, low-risk prostate cancer, and stage I-IVA papillary or follicular thyroid cancer
• • Known metastatic disease
• • Unable to complete QOL questionnaires
• • Pregnant or lactating women