Transoral robotic surgery for early oropharyngeal cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational cohort study investigates the outcomes of local recurrence-free survival in patients with early-stage oropharyngeal squamous cell carcinoma who undergo transoral robotic surgery, with or without additional therapy. It includes a multi-centre retrospective analysis and optional exploratory studies on radiomics and molecular characteristics. The study aims to determine safe margin cut-offs to minimize local recurrence risk and assess post-operative complications. Additionally, it will analyze circulating tumor DNA levels to better understand recurrence patterns.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 18 years and older.
* Primary tumour within the oropharynx (defined as tonsil, soft palate, tongue base, lateral and posterior oropharyngeal walls)
* Histologically confirmed squamous cell carcinoma.
* P16 positive or negative tumours
* Index cancer treated with TORS with or without adjuvant therapy.
* Early pT1-T2 stage oropharyngeal SCC
* TORS performed on or before 31st December 2021

For the exploratory analysis only:

* Ability to consent to molecular analysis study
* Ability to consent to radiomic/ imaging study (as required for international centres)

Exclusion Criteria:

* Moderate to advanced stage T3-T4 oropharyngeal SCC
* TORS performed for diagnostic, recurrent, or palliative intentions.
* Prior history of head and neck cancer or radiation therapy at any time
* Known distant metastatic disease.
* Nasopharyngeal, thyroid, cutaneous, and non-SCC head and neck cancers.

Where it's running

• The Royal Marsden Hospital NHS Foundation Trust
  London, United Kingdom Recruiting

Study contacts

• Principal investigator: Vinidh Paleri — Royal Marsden Hospital NHS Foundation Trust
• Study coordinator: Andrew Williamson
• Email: andrew.williamson2@rmh.nhs.uk
• Phone: 02000000000

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.