Status:
COMPLETED
Transoral Robotic Surgery and Tailored Radiotherapy in Unknown Primary and Small Squamous Cell Head and Neck Cancer
Lead Sponsor:
University Health Network, Toronto
Conditions:
Head and Neck Squamous Cell Carcinoma
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to evaluate the use of Transoral Robotic Surgery (TORS) to identify small oropharyngeal carcinomas. Findings from this study will be used to better determine which patient...
Detailed Description
Patients who present with carcinomas of unknown primary site (CUP) of the head and neck represent a challenging problem for clinicians both from a diagnostic and therapeutic perspective. Traditional t...
Eligibility Criteria
Inclusion
- Age \>= 18
- Metastatic squamous cell carcinoma (T0,N1-3,M0) to at least one regional lymph node of the neck (includes N1-N3) based on fine needle aspiration (FNA) biopsy, core biopsy, excisional biopsy, or neck dissection
- Ability to understand and willing to sign a written informed consent document
- Women of child-producing potential must agree to use effective contraceptive methods prior to study entry, during study participation, and for at least 30 days after the last administration of study medication.
Exclusion
- Evidence of a nasopharyngeal carcinoma by one or more of the following methods: endoscopic examination, imaging, positive nasopharyngeal biopsy or core lymph node biopsy staining for Epstein Barr Encoded RNA (EBER) by In Situ Hybridization.
- Prior non-cutaneous head and neck squamous cell carcinoma
- Prior head and neck radiotherapy
- History of neck dissection - contralateral to the side of the nodal disease
- Presence of lymphadenopathy on CT unlikely to originate from a primary oropharyngeal carcinoma (i.e., parotid, isolated low (level IV/low level V)
- Radiologically abnormal/enlarged retropharyngeal adenopathy.
- Poor performance status (ECOG status 3 - 5)
- Severe comorbidity or uncontrolled inter-current illness (i.e., unstable angina or heart failure in last 6 months, myocardial infarction in last 6 months, chronic obstructive pulmonary disease with exacerbations necessitating hospitalization or emergency room visit in the past 3 months, history of pneumonia in the past 3 months, use of home oxygen, uncorrectable coagulopathy)
- Not a surgical candidate
- Pregnancy
Key Trial Info
Start Date :
August 15 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 19 2022
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT03281499
Start Date
August 15 2017
End Date
July 19 2022
Last Update
August 1 2023
Active Locations (1)
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1
Princess Margaret Cancer Centre
Toronto, Ontario, Canada