Transoral Robotic Surgery and Tailored Radiotherapy in Unknown Primary and Small Squamous Cell Head and Neck Cancer (FIND)
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|ClinicalTrials.gov Identifier: NCT03281499|
Recruitment Status : Active, not recruiting
First Posted : September 13, 2017
Last Update Posted : April 19, 2021
|Condition or disease||Intervention/treatment||Phase|
|Head and Neck Squamous Cell Carcinoma||Other: da Vinci Surgical System Model IS4000||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||22 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||There will only be a single group of participants in this study|
|Masking:||None (Open Label)|
|Masking Description:||No masking will be used in this study for both participants and the study team|
|Official Title:||A Pilot Study Integrating Transoral Robotic Surgery, Histopathologic Localization, and Tailored De-Intensification of Radiotherapy for Unknown Primary and Small Oropharyngeal Head and Neck Squamous Cell Carcinoma(FIND Trial)|
|Actual Study Start Date :||August 15, 2017|
|Estimated Primary Completion Date :||August 2022|
|Estimated Study Completion Date :||August 2022|
Experimental: da Vinci Surgical System Model IS4000
Transoral robotic surgery, followed by tailored radiotherapy
Other: da Vinci Surgical System Model IS4000
tailored radiotherapy regimen following transoral robotic surgery
Other Name: tailored radiotherapy regimen
- Determination of the rate of out-of-field failures following treatment [ Time Frame: 2 years ]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.
- Adverse Events (AE) monitoring [ Time Frame: 2 years ]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)
- Determination of proportions of occult oropharyngeal cancers identified [ Time Frame: 2 years ]To determine the proportion of patients with occult oropharyngeal cancers identified
- Location of primary tumours identified through enumeration of patients in each identified site group [ Time Frame: 2 years ]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
- Determination of the proportion of patients with completely resected primary tumours [ Time Frame: 2 years ]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).
- Determination of the proportion of patients patients amenable to de-intensification treatment [ Time Frame: 2 years ]Determination of the proportion of patients patients amenable to de-intensification treatment
- Exploration of expert rated swallowing impairment [ Time Frame: 2 years ]To explore expert rated swallowing impairment on video fluoroscopic swallow studies (VFSS) using the Modified Barium Swallow Impairment (MBS-Imp)instrument tool 2 years
- Exploration of patient reported swallowing related quality of life [ Time Frame: 2 years ]To explore patient reported swallowing related quality of life using the MD Anderson Dysphagia Inventory (MDADI)
- Exploration of speech and swallowing performance status [ Time Frame: 2 years ]To explore observer rated speech and swallowing using the Performance Status Scale for Head and Neck (PSS-HN) instrument
- Exploration of patient reported neck impairment [ Time Frame: 2 years ]To explore patient reported neck impairment using the Neck Dissection Impairment Index (NDII) instrument
- Determination of patterns of failure by location [ Time Frame: 2 years ]To determine patterns of failure by location (local, regional, distant) as determined by CT/MRI of the Head and Neck and/or biopsy.
- Rates of survival after treatment [ Time Frame: 2 years ]To determine rates of survival at 2 years
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03281499
|Princess Margaret Cancer Centre|
|Toronto, Ontario, Canada|
|Principal Investigator:||John de Almeida, MD||University Health Network, Toronto|