Transoral robotic surgery for early oropharyngeal cancer
Single and Combined Modality Trans-Oral Robotic Surgery in Early Oropharyngeal Cancer: Exploring the Impact of Surgical Margins on Local Disease Recurrence: The SCORE Study
This study is testing how well transoral robotic surgery works for people with early-stage throat cancer and whether it helps them avoid cancer coming back, while also looking at any complications and other factors that might affect their recovery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 250 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Royal Marsden NHS Foundation Trust Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (London) |
| Trial ID | NCT05933889 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with early-stage (T1-T2) oropharyngeal squamous cell carcinoma treated with transoral robotic surgery.
Not a fit: Patients with moderate to advanced stage oropharyngeal cancer or those with a history of head and neck cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve surgical outcomes and reduce recurrence rates in patients with early oropharyngeal cancer.
How similar studies have performed: Other studies have shown promising results with robotic surgical approaches in head and neck cancers, suggesting potential for success in this study.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
London
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.