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

Primary Purpose

Head and Neck Squamous Cell Carcinoma

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
da Vinci Surgical System Model IS4000
Sponsored by
University Health Network, Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head and Neck Squamous Cell Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Princess Margaret Cancer Centre

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

da Vinci Surgical System Model IS4000

Arm Description

Transoral robotic surgery, followed by tailored radiotherapy

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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)
Determination of proportions of occult oropharyngeal cancers identified
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
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
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
Determination of the proportion of patients patients amenable to de-intensification treatment
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
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)
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
Exploration of patient reported neck impairment
To explore patient reported neck impairment using the Neck Dissection Impairment Index (NDII) instrument
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.
Rates of survival after treatment
To determine rates of survival at 2 years

Full Information

First Posted
August 21, 2017
Last Updated
July 30, 2023
Sponsor
University Health Network, Toronto
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1. Study Identification

Unique Protocol Identification Number
NCT03281499
Brief Title
Transoral Robotic Surgery and Tailored Radiotherapy in Unknown Primary and Small Squamous Cell Head and Neck Cancer
Acronym
FIND
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)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
August 15, 2017 (Actual)
Primary Completion Date
July 19, 2022 (Actual)
Study Completion Date
July 19, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Health Network, Toronto

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Squamous Cell Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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
Allocation
N/A
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
da Vinci Surgical System Model IS4000
Arm Type
Experimental
Arm Description
Transoral robotic surgery, followed by tailored radiotherapy
Intervention Type
Other
Intervention Name(s)
da Vinci Surgical System Model IS4000
Other Intervention Name(s)
tailored radiotherapy regimen
Intervention Description
tailored radiotherapy regimen following transoral robotic surgery
Primary Outcome Measure Information:
Title
Determination of the rate of out-of-field failures following treatment
Description
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
Secondary Outcome Measure Information:
Title
Adverse Events (AE) monitoring
Description
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
Title
Determination of proportions of occult oropharyngeal cancers identified
Description
To determine the proportion of patients with occult oropharyngeal cancers identified
Time Frame
2 years
Title
Location of primary tumours identified through enumeration of patients in each identified site group
Description
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
Title
Determination of the proportion of patients with completely resected primary tumours
Description
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
Title
Determination of the proportion of patients patients amenable to de-intensification treatment
Description
Determination of the proportion of patients patients amenable to de-intensification treatment
Time Frame
2 years
Title
Exploration of expert rated swallowing impairment
Description
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
Title
Exploration of patient reported swallowing related quality of life
Description
To explore patient reported swallowing related quality of life using the MD Anderson Dysphagia Inventory (MDADI)
Time Frame
2 years
Title
Exploration of speech and swallowing performance status
Description
To explore observer rated speech and swallowing using the Performance Status Scale for Head and Neck (PSS-HN) instrument
Time Frame
2 years
Title
Exploration of patient reported neck impairment
Description
To explore patient reported neck impairment using the Neck Dissection Impairment Index (NDII) instrument
Time Frame
2 years
Title
Determination of patterns of failure by location
Description
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
Title
Rates of survival after treatment
Description
To determine rates of survival at 2 years
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John de Almeida, MD
Organizational Affiliation
University Health Network, Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
Princess Margaret Cancer Centre
City
Toronto
State/Province
Ontario
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
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Transoral Robotic Surgery and Tailored Radiotherapy in Unknown Primary and Small Squamous Cell Head and Neck Cancer

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