Status:
NOT_YET_RECRUITING
Surgery and Reducing Ionizing Radiation of the Unknown Primary
Lead Sponsor:
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Collaborating Sponsors:
Dr. Jake Jervis-Bardy
Dr. David Palma
Conditions:
Head and Neck Squamous Cell Carcinoma
HPV Positive Oropharyngeal Squamous Cell Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
About 3% of people with head and neck cancer have cancer in their lymph nodes, but doctors are unable to find the primary tumour. This situation has become more common due to human papillomavirus (HPV...
Detailed Description
Approximately 3% of all head and neck squamous cell carcinoma (SCC) patients present with nodal disease from an unknown primary (PUK). The incidence of PUK has increased in tandem with the rise of hum...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
January 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 30 2027
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT06578871
Start Date
January 1 2025
End Date
May 30 2027
Last Update
September 3 2024
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Royal Adelaide Hospital
Adelaide, South Australia, Australia, 5000
2
Flinders Medical Centre
Adelaide, South Australia, Australia, 5042
3
London Health Sciences Centre
London, Ontario, Canada, N6A 5W9