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

Titre officiel

A Pilot Study Integrating Transoral Robotic Surgery, Histopathologic Localization, and Tailored De-Intensification of Radiation Therapy for Unknown Primary and Small Oropharyngeal Head and Neck Squamous Cell Carcinoma(FIND Trial)

Sommaire:

Le but de cette étude est d’évaluer l’utilisation de la chirurgie robotique transorale (CRTO) pour détecter les petits carcinomes oropharyngés. Les résultats de cette étude serviront à mieux déterminer quels patients pourraient être de bons candidats à une radiothérapie plus ciblée permettant de réduire la quantité totale de radiothérapie nécessaire dans le cadre de leur traitement. Il a été démontré que la quantité moindre de radiothérapie reçue réduit le risque de complications tardives et de toxicité chez les patients. Les résultats pathologiques seront ensuite utilisés pour déterminer quels patients pourraient être candidats à la désintensification de la radiothérapie.

Description de l'essai

Primary Outcome:

  • Determination of the rate of out-of-field failures following treatment
Secondary Outcome:
  • Adverse Events (AE) monitoring
  • Determination of proportions of occult oropharyngeal cancers identified
  • Location of primary tumours identified through enumeration of patients in each identified site group
  • Determination of the proportion of patients with completely resected primary tumours
  • Determination of the proportion of patients patients amenable to de-intensification treatment
  • Exploration of expert rated swallowing impairment
  • Exploration of patient reported swallowing related quality of life
  • Exploration of speech and swallowing performance status
  • Exploration of patient reported neck impairment
  • Determination of patterns of failure by location
  • Rates of survival after treatment
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 tumours 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 tumours, the remaining unidentified tumours 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 radiation therapy 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.

Voir cet essai sur ClinicalTrials.gov

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