Clinical trial · Interventional
Transoral Robotic Surgery and Tailored Radiotherapy in Unknown Primary and Small Squamous Cell Head and Neck Cancer
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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Squamous Cell Carcinoma | Head and Neck Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| da Vinci Surgical System Model IS4000 | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- da Vinci Surgical System Model IS4000
- description
- Transoral robotic surgery, followed by tailored radiotherapy
- interventionNames
- Other: da Vinci Surgical System Model IS4000
Primary outcomes (1)
- measure
- Determination of the rate of out-of-field failures following treatment
- timeFrame
- 2 years
- 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.
Secondary outcomes (11)
- measure
- Adverse Events (AE) monitoring
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (13)
- BACKGROUNDKostakoglu 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
- BACKGROUNDStrojan 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
- BACKGROUNDRodel 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
- BACKGROUNDWaltonen 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
- BACKGROUNDJones 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
- BACKGROUNDCianchetti 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.