NCT05933889 Single and Combined Modality Trans-Oral Robotic Surgery in Early Oropharyngeal Cancer
| NCT ID | NCT05933889 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Royal Marsden NHS Foundation Trust |
| Condition | Cancer Head Neck |
| Study Type | OBSERVATIONAL |
| Enrollment | 250 participants |
| Start Date | 2023-12-19 |
| Primary Completion | 2027-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 250 participants in total. It began in 2023-12-19 with a primary completion date of 2027-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Multi-centre retrospective observational cohort study with optional exploratory radiomic study (international) and prospective molecular analysis studies (UK only).
Eligibility 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.
Contact & Investigator
Vinidh Paleri
PRINCIPAL INVESTIGATOR
Royal Marsden Hospital NHS Foundation Trust
Frequently Asked Questions
Who can join the NCT05933889 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cancer Head Neck. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05933889 currently recruiting?
Yes, NCT05933889 is actively recruiting participants. Contact the research team at andrew.williamson2@rmh.nhs.uk for enrollment information.
Where is the NCT05933889 trial being conducted?
This trial is being conducted at London, United Kingdom.
Who is sponsoring the NCT05933889 clinical trial?
NCT05933889 is sponsored by Royal Marsden NHS Foundation Trust. The principal investigator is Vinidh Paleri at Royal Marsden Hospital NHS Foundation Trust. The trial plans to enroll 250 participants.
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