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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03281499
Recruitment Status : Recruiting
First Posted : September 13, 2017
Last Update Posted : October 24, 2019
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto

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.

Condition or disease Intervention/treatment Phase
Head and Neck Squamous Cell Carcinoma Other: da Vinci Surgical System Model IS4000 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 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
Primary Purpose: Treatment
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 2020
Estimated Study Completion Date : August 2021

Resource links provided by the National Library of Medicine


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 Name: tailored radiotherapy regimen




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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. Determination of proportions of occult oropharyngeal cancers identified [ Time Frame: 2 years ]
    To determine the proportion of patients with occult oropharyngeal cancers identified

  3. 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

  4. 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).

  5. 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

  6. 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

  7. 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)

  8. 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

  9. Exploration of patient reported neck impairment [ Time Frame: 2 years ]
    To explore patient reported neck impairment using the Neck Dissection Impairment Index (NDII) instrument

  10. 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.

  11. Rates of survival after treatment [ Time Frame: 2 years ]
    To determine rates of survival at 2 years



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Contacts
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Contact: Risho Yogananthan 4169464501 ext 4722 Risho.Yogananthan@uhn.ca
Contact: Kathryn Sabate 4169464501 ext 3656 Kathryn.Sabate@uhn.ca

Locations
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Canada, Ontario
London Health Sciences Centre Recruiting
London, Ontario, Canada, N6A 5W9
Contact: Anthony Nichols, MD    519-685-8500 ext 58804    Anthony.nichols@lhsc.on.ca   
Contact: Shamim Mortuza    519-685-8618    Shamim.mortuza@lhsc.on.ca   
Principal Investigator: Anthony Nichols, MD         
Princess Margaret Cancer Centre Recruiting
Toronto, Ontario, Canada
Contact: Amit Oza, MD    416-946-2818      
Contact: Risho Yogananthan    416-946-4501 ext 4722    Risho.Yogananthan@uhn.ca   
Principal Investigator: John de Almeida, MD         
Sponsors and Collaborators
University Health Network, Toronto
Investigators
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Principal Investigator: John de Almeida, MD University Health Network, Toronto

Publications of Results:
Other Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT03281499    
Other Study ID Numbers: FIND Trial
First Posted: September 13, 2017    Key Record Dates
Last Update Posted: October 24, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Head and Neck Neoplasms
Neoplasms by Site