An interventional study of da Vinci Surgical System Model IS4000 in Head and Neck Squamous Cell Carcinoma, sponsored by University Health Network, Toronto. Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-08-01.
Sponsored by University Health Network, Toronto · Not applicable, Interventional, and Treatment
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 patients may be suitable for more targeted radiotherapy that would lead to a reduction in the total amount of radiotherapy needed as part of their treatment. Reducing the amount of radiotherapy received has been found to reduce the risk of late complications and toxicity to the patient.The pathologic findings will then be used to determine patients who may be candidates for de-intensification of radiotherapy.
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 techniques for identification of primary tumors involved a Positron Emission Tomography scan (PET)/ computerized tomography scan(CT) followed by examination under anesthesia with biopsies of the nasopharynx, tongue base, piriform sinuses in conjunction with a tonsillectomy may identify as many as 44% of primary tumors, the remaining unidentified tumors are treated with mucosal irradiation to all high risk mucosal sites. The addition of a lingual tonsillectomy with Transoral Robotic Surgery (TORS) may identify almost 70% of primary tumours that have otherwise escaped initial identification at this timepoint,. Historically, for those whose primary would not be discovered at the PET/CT, the discovery would have been made later during follow up visits.
The investigators propose to integrate Transoral Robotic Surgery into the diagnostic evaluation of participants presenting with metastatic squamous cell carcinoma to the neck of unknown primary origin. The investigators will localize small hidden oropharyngeal carcinomas, determine their laterality, and based on the laterality of the tumour, laterality of neck nodes, and completeness of resection, will offer reduced radiotherapy to the primary site and/or to the neck (de-intensification)to the participant. The investigators hypothesize that this approach to unknown primary carcinomas will be both safe and effective.
Exclusion Criteria:
Transoral robotic surgery, followed by tailored radiotherapy
Other: da Vinci Surgical System Model IS4000
tailored radiotherapy regimen following transoral robotic surgery
Also known as: tailored radiotherapy regimen
Determination of the rate of out-of-field failures following treatment
The primary outcome for the study is to determine the rate of out-of-field failures following treatment as determined by use of morphologic imaging (contrast enhanced CT or MRI of the head) and confirmed by biopsy.
Time frame: 2 years
Adverse Events (AE) monitoring
To determine the profile of TORS related complications and Surgical Adverse Events within 30 days of surgery using National Cancer Institute Common Terminology Criteria (CTC) for Adverse Events (NCI CTC-AE v 4.0)
Time frame: 2 years
Determination of proportions of occult oropharyngeal cancers identified
To determine the proportion of patients with occult oropharyngeal cancers identified
Time frame: 2 years
Location of primary tumours identified through enumeration of patients in each identified site group
To determine the location of primary tumours identified through enumeration of patients in each identified site group. The study data will be sorted by location of primary tumour and the proportions for each location calculated
Time frame: 2 years
Determination of the proportion of patients with completely resected primary tumours
To determine the location of primary tumours identified, the proportion of patients with primary oropharyngeal carcinomas completely resected (with negative margins), and the proportion of patients amenable to de-intensification treatment (ie, patients who receive no radiotherapy to the primary site and/or unilateral neck radiotherapy).
Time frame: 2 years
Determination of the proportion of patients patients amenable to de-intensification treatment
Determination of the proportion of patients patients amenable to de-intensification treatment
Time frame: 2 years
Exploration of expert rated swallowing impairment
To explore expert rated swallowing impairment on video fluoroscopic swallow studies (VFSS) using the Modified Barium Swallow Impairment (MBS-Imp)instrument tool 2 years
Time frame: 2 years
Exploration of patient reported swallowing related quality of life
To explore patient reported swallowing related quality of life using the MD Anderson Dysphagia Inventory (MDADI)
Time frame: 2 years
Exploration of speech and swallowing performance status
To explore observer rated speech and swallowing using the Performance Status Scale for Head and Neck (PSS-HN) instrument
Time frame: 2 years
Exploration of patient reported neck impairment
To explore patient reported neck impairment using the Neck Dissection Impairment Index (NDII) instrument
Time frame: 2 years
Determination of patterns of failure by location
To determine patterns of failure by location (local, regional, distant) as determined by CT/MRI of the Head and Neck and/or biopsy.
Time frame: 2 years
Rates of survival after treatment
To determine rates of survival at 2 years
Time frame: 2 years
Plan to share: No
This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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University Health Network, Toronto