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

NCT03281499 | Completed DMC

• 1 other identifier: FIND Trial
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Head and Neck Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• 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.

  2 years

Secondary Outcomes (11)

• Adverse Events (AE) monitoring

  2 years

• Determination of proportions of occult oropharyngeal cancers identified

  2 years

• Location of primary tumours identified through enumeration of patients in each identified site group

  2 years

• Determination of the proportion of patients with completely resected primary tumours

  2 years

• Determination of the proportion of patients patients amenable to de-intensification treatment

  2 years

Study Arms (1)

da Vinci Surgical System Model IS4000

EXPERIMENTAL

Transoral robotic surgery, followed by tailored radiotherapy

Other: da Vinci Surgical System Model IS4000

Interventions

da Vinci Surgical System Model IS4000 OTHER

tailored radiotherapy regimen following transoral robotic surgery

Also known as: tailored radiotherapy regimen

da Vinci Surgical System Model IS4000

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Location

Related Publications (13)

• Kostakoglu L, Fardanesh R, Posner M, Som P, Rao S, Park E, Doucette J, Stein EG, Gupta V, Misiukiewicz K, Genden E. Early detection of recurrent disease by FDG-PET/CT leads to management changes in patients with squamous cell cancer of the head and neck. Oncologist. 2013;18(10):1108-17. doi: 10.1634/theoncologist.2013-0068. Epub 2013 Sep 13.

  PMID: 24037978 BACKGROUND

• Strojan P, Ferlito A, Medina JE, Woolgar JA, Rinaldo A, Robbins KT, Fagan JJ, Mendenhall WM, Paleri V, Silver CE, Olsen KD, Corry J, Suarez C, Rodrigo JP, Langendijk JA, Devaney KO, Kowalski LP, Hartl DM, Haigentz M Jr, Werner JA, Pellitteri PK, de Bree R, Wolf GT, Takes RP, Genden EM, Hinni ML, Mondin V, Shaha AR, Barnes L. Contemporary management of lymph node metastases from an unknown primary to the neck: I. A review of diagnostic approaches. Head Neck. 2013 Jan;35(1):123-32. doi: 10.1002/hed.21898. Epub 2011 Oct 27.

  PMID: 22034046 BACKGROUND

• Rodel RM, Matthias C, Blomeyer BD, Wolff HA, Jung K, Christiansen H. Impact of distant metastasis in patients with cervical lymph node metastases from cancer of an unknown primary site. Ann Otol Rhinol Laryngol. 2009 Sep;118(9):662-9. doi: 10.1177/000348940911800911.

  PMID: 19810608 BACKGROUND

• Waltonen JD, Ozer E, Hall NC, Schuller DE, Agrawal A. Metastatic carcinoma of the neck of unknown primary origin: evolution and efficacy of the modern workup. Arch Otolaryngol Head Neck Surg. 2009 Oct;135(10):1024-9. doi: 10.1001/archoto.2009.145.

  PMID: 19841343 BACKGROUND

• Jones AS, Cook JA, Phillips DE, Roland NR. Squamous carcinoma presenting as an enlarged cervical lymph node. Cancer. 1993 Sep 1;72(5):1756-61. doi: 10.1002/1097-0142(19930901)72:53.0.co;2-5.

  PMID: 8348505 BACKGROUND

• Cianchetti M, Mancuso AA, Amdur RJ, Werning JW, Kirwan J, Morris CG, Mendenhall WM. Diagnostic evaluation of squamous cell carcinoma metastatic to cervical lymph nodes from an unknown head and neck primary site. Laryngoscope. 2009 Dec;119(12):2348-54. doi: 10.1002/lary.20638.

  PMID: 19718744 BACKGROUND

• Chaturvedi AK, Anderson WF, Lortet-Tieulent J, Curado MP, Ferlay J, Franceschi S, Rosenberg PS, Bray F, Gillison ML. Worldwide trends in incidence rates for oral cavity and oropharyngeal cancers. J Clin Oncol. 2013 Dec 20;31(36):4550-9. doi: 10.1200/JCO.2013.50.3870. Epub 2013 Nov 18.

  PMID: 24248688 BACKGROUND

• D'Souza G, Kreimer AR, Viscidi R, Pawlita M, Fakhry C, Koch WM, Westra WH, Gillison ML. Case-control study of human papillomavirus and oropharyngeal cancer. N Engl J Med. 2007 May 10;356(19):1944-56. doi: 10.1056/NEJMoa065497.

  PMID: 17494927 BACKGROUND

• Chaturvedi AK, Engels EA, Pfeiffer RM, Hernandez BY, Xiao W, Kim E, Jiang B, Goodman MT, Sibug-Saber M, Cozen W, Liu L, Lynch CF, Wentzensen N, Jordan RC, Altekruse S, Anderson WF, Rosenberg PS, Gillison ML. Human papillomavirus and rising oropharyngeal cancer incidence in the United States. J Clin Oncol. 2011 Nov 10;29(32):4294-301. doi: 10.1200/JCO.2011.36.4596. Epub 2011 Oct 3.

  PMID: 21969503 BACKGROUND

• Ali AN, Switchenko JM, Kim S, Kowalski J, El-Deiry MW, Beitler JJ. A model and nomogram to predict tumor site origin for squamous cell cancer confined to cervical lymph nodes. Cancer. 2014 Nov 15;120(22):3469-76. doi: 10.1002/cncr.28901. Epub 2014 Jul 24.

  PMID: 25060659 BACKGROUND

• Abuzeid WM, Bradford CR, Divi V. Transoral robotic biopsy of the tongue base: A novel paradigm in the evaluation of unknown primary tumors of the head and neck. Head Neck. 2013 Apr;35(4):E126-30. doi: 10.1002/hed.21968. Epub 2011 Dec 16.

  PMID: 22180229 RESULT

• de Almeida JR, Martino R, Hosni A, Goldstein DP, Bratman SV, Chepeha DB, Waldron JN, Weinreb I, Perez-Ordonez B, Yu E, Metser U, Hansen AR, Xu W, Su SJ, Kim J. Transoral Robotic Surgery and Radiation Volume Deintensification in Unknown Primary Squamous Cell Carcinoma of the Neck: The Phase 2 FIND Nonrandomized Controlled Trial. JAMA Otolaryngol Head Neck Surg. 2024 Jun 1;150(6):463-471. doi: 10.1001/jamaoto.2024.0423.

  PMID: 38602692 DERIVED

• de Almeida JR, Noel CW, Veigas M, Martino R, Chepeha DB, Bratman SV, Goldstein DP, Hansen AR, Yu E, Metser U, Weinreb I, Perez-Ordonez B, Xu W, Kim J. Finding/identifying primaries with neck disease (FIND) clinical trial protocol: a study integrating transoral robotic surgery, histopathological localisation and tailored deintensification of radiotherapy for unknown primary and small oropharyngeal head and neck squamous cell carcinoma. BMJ Open. 2019 Dec 30;9(12):e035431. doi: 10.1136/bmjopen-2019-035431.

  PMID: 31892671 DERIVED

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Study Officials

• John de Almeida, MD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: No masking will be used in this study for both participants and the study team
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: There will only be a single group of participants in this study

Study Record Dates

• First Submitted: August 21, 2017
• First Posted: September 13, 2017
• Study Start: August 15, 2017
• Primary Completion: July 19, 2022
• Study Completion: July 19, 2022
• Last Updated: August 1, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)