Head and Neck Squamous Cell CarcinomaFINDNCT03281499
Transoral Robotic Surgery and Tailored Radiotherapy in Unknown Primary and Small Squamous Cell Head and Neck Cancer
A study testing da Vinci Surgical System Model IS4000 in people with Head and Neck Squamous Cell Carcinoma, run by University Health Network, Toronto at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Squamous Cell Carcinoma
- What is being tested?
- da Vinci Surgical System Model IS4000
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteCanada
- Study dates
- 15 Aug 2017to 19 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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)
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.
Read the 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.
- Conditions
- Head and Neck Squamous Cell Carcinoma
- Being tested
- da Vinci Surgical System Model IS4000
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
da Vinci Surgical System Model IS4000Other
Also called tailored radiotherapy regimen
tailored radiotherapy regimen following transoral robotic surgery
| Study group | Role | What they receive |
|---|---|---|
| da Vinci Surgical System Model IS4000 | Experimental | Transoral robotic surgery, followed by tailored radiotherapy Receives: Other: da Vinci Surgical System Model IS4000 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Secondary outcomes (11)
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)
Measured: 2 years
Determination of proportions of occult oropharyngeal cancers identified
To determine the proportion of patients with occult oropharyngeal cancers identified
Measured: 2 years
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
Measured: 2 years
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).
Measured: 2 years
Determination of the proportion of patients patients amenable to de-intensification treatment
Determination of the proportion of patients patients amenable to de-intensification treatment
Measured: 2 years
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
Measured: 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)
Measured: 2 years
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
Measured: 2 years
Exploration of patient reported neck impairment
To explore patient reported neck impairment using the Neck Dissection Impairment Index (NDII) instrument
Measured: 2 years
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.
Measured: 2 years
Rates of survival after treatment
To determine rates of survival at 2 years
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2017
- Study start15 Aug 2017
- Primary completion19 Jul 2022
- Study completion19 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Head and Neck Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- There will only be a single group of participants in this study
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John de Almeida, MD, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03281499
- Sponsor's protocol ID
- FIND Trial
- Acronym
- FIND
- Status last verified
- Jul 2023
- First submitted
- 21 Aug 2017
- Last updated
- 1 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 24037978Strojan 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.
PubMed 22034046Rodel 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.
PubMed 19810608Waltonen 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.
PubMed 19841343Jones 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.
PubMed 8348505Cianchetti 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.
PubMed 19718744Chaturvedi 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.
PubMed 24248688D'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.
PubMed 17494927Chaturvedi 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.
PubMed 21969503Ali 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.
PubMed 25060659Abuzeid 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.
PubMed 22180229de 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.
PubMed 38602692de 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.
PubMed 31892671
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with 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)
- ClinicalTrials.gov ID
- NCT03281499
- Acronym / sponsor ID
- FIND / FIND Trial
- Conditions
- Head and Neck Squamous Cell Carcinoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 15 Aug 2017 (actual)
- Primary completion
- 19 Jul 2022 (actual)
- Study completion
- 19 Jul 2022 (actual)
- First posted
- 13 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- There will only be a single group of participants in this study
| Arm | Type | Receives |
|---|---|---|
| da Vinci Surgical System Model IS4000 | Experimental | Other: da Vinci Surgical System Model IS4000Transoral robotic surgery, followed by tailored radiotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| da Vinci Surgical System Model IS4000Also: tailored radiotherapy regimentailored radiotherapy regimen following transoral robotic surgery | Other | da Vinci Surgical System Model IS4000 |
Primary outcome
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.
11 secondary outcomes
Adverse Events (AE) monitoring
Time frame: 2 years
Determination of proportions of occult oropharyngeal cancers identified
Time frame: 2 years
Location of primary tumours identified through enumeration of patients in each identified site group
Time frame: 2 years
Determination of the proportion of patients with completely resected primary tumours
Time frame: 2 years
Determination of the proportion of patients patients amenable to de-intensification treatment
Time frame: 2 years
Exploration of expert rated swallowing impairment
Time frame: 2 years
Exploration of patient reported swallowing related quality of life
Time frame: 2 years
Exploration of speech and swallowing performance status
Time frame: 2 years
Exploration of patient reported neck impairment
Time frame: 2 years
Determination of patterns of failure by location
Time frame: 2 years
Rates of survival after treatment
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2023.
- Background: PubMed 24037978Kostakoglu 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.
- Background: PubMed 22034046Strojan 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.
- Background: PubMed 19810608Rodel 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.
- Background: PubMed 19841343Waltonen 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.
- Background: PubMed 8348505Jones 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.
- Background: PubMed 19718744Cianchetti 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.
- Background: PubMed 24248688Chaturvedi 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.
- Background: PubMed 17494927D'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.
- Background: PubMed 21969503Chaturvedi 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.
- Background: PubMed 25060659Ali 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.
- Results publication: PubMed 22180229Abuzeid 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.
- Derived from this study: PubMed 38602692de 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.
- Individual participant dataSharing planned: No
Related trials for Head and Neck Squamous Cell Carcinoma
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
RecruitingObservational study
Multicenter Prospective Cohort on Esophageal Endoscopic Submucosal Dissection
Superficial Esophageal Cancer, Oesophageal Adenocarcinoma
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
Not yet recruiting
Tumoral Versus Luminal Microbiome in Head and Neck Squamous Cell Carcinoma
Squamous Cell Cancer of Head and Neck (SCCHN)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John de Almeida, MD principal investigator
University Health Network, Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing da Vinci Surgical System Model IS4000 in people with Head and Neck Squamous Cell Carcinoma, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determination of the rate of out-of-field failures following treatment (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03281499, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2023.