Transoral Robotic Surgery and Tailored Radiotherapy in Unknown Primary and Small Squamous Cell Head and Neck Cancer (FIND)

July 30, 2023 updated by: University Health Network, Toronto

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 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

Enrollment (Actual)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada
        • Princess Margaret Cancer Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • tailored radiotherapy regimen

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
2 years
Determination of proportions of occult oropharyngeal cancers identified
Time Frame: 2 years
To determine the proportion of patients with occult oropharyngeal cancers identified
2 years
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
2 years
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).
2 years
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
2 years
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
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)
2 years
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
2 years
Exploration of patient reported neck impairment
Time Frame: 2 years
To explore patient reported neck impairment using the Neck Dissection Impairment Index (NDII) instrument
2 years
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.
2 years
Rates of survival after treatment
Time Frame: 2 years
To determine rates of survival at 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Health Network, Toronto

Investigators

  • Principal Investigator: John de Almeida, MD, University Health Network, Toronto

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 15, 2017

Primary Completion (Actual)

July 19, 2022

Study Completion (Actual)

July 19, 2022

Study Registration Dates

First Submitted

August 21, 2017

First Submitted That Met QC Criteria

September 12, 2017

First Posted (Actual)

September 13, 2017

Study Record Updates

Last Update Posted (Actual)

August 1, 2023

Last Update Submitted That Met QC Criteria

July 30, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FIND Trial

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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