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Single and Combined Modality Trans-Oral Robotic Surgery in Early Oropharyngeal Cancer

View on ClinicalTrials.gov ↗

At a glance

What the study gets you: Health checks and monitoring — no treatment given
Type of study: Observational (no treatment given)
Time in hospital: In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention: Molecular Analysis (genetic), Radiomic/ Morphological analysis (other)
How long the study runs: Study runs about 44 months (dates as stated)
About the drug or intervention: Molecular Analysis — genetic: Germline and circulating tumour DNA analysis of buccal/ blood samples and molecular analysis of primary and recurrent tumour tissue samples · Radiomic/ Morphological analysis — other: Radiomic analysis and assessment of morphological features of pre-operative CT/ MRI imaging in patients who have undergone TORS for primary oropharyngeal cancer.
Patient visit burden: Not specified by the sponsor

Type of study: Observing health over time
Ages: 18 Years and over
Who: All
Number of participants: 250
Started: 2023-12-19
Last checked: 2024-08

Plain English Summary

What is this study?

• Testing a new treatment for cancer head neck
• Clinical study - 250 participants
• Multi-centre retrospective observational cohort study with optional exploratory radiomic study (international) and prospective molecular analysis studies (UK only)

Who can take part?

• Ages 18 Years and over
• Diagnosed with cancer head neck

Where?

• London - The Royal Marsden Hospital NHS Foundation Trust

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

Multi-centre retrospective observational cohort study with optional exploratory radiomic study (international) and prospective molecular analysis studies (UK only).

More detail

The SCORE study is a international multicentre cohort study investigating the local recurrence free survival outcomes in patients undergoing transoral robotic surgery with and without adjuvant therapy for early stage (T1-T2) oropharyngeal squamous cell carcinoma (OPSCC). Important secondary objectives include assessment of other survival measures (overall, disease free and disease specific), determination of a safe margin "cut off" that minimises the risk of local recurrence, and reporting the rate of early post-operative complications and mortality. Retrospective SCORE patients will optionally contain an exploratory radiomic and radiology morphological analysis to ascertain high risk features of positive margins and local recurrence following TORS for early oropharyngeal cancer. Additionally, the SCORE study will contain a prospective exploratory molecular analysis of consenting patients to help further define OPSCC molecular characteristics in those who experience recurrence and those who do not, in addition to assessing levels of circulating tumour DNA in before and after TORS procedures.

Cancer Head Neck

How this trial compares with your answers

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What we know so far

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

Age: 18 Years and over
Who can join: All genders

Biomarkers mentioned

P16 positiveor negative

Treatment history

Treatments you must have had:

✓ for international centres)

What the study is looking for

✓18 years and older.
✓Primary tumour within the oropharynx (defined as tonsil, soft palate, tongue base, lateral and posterior...
✓confirmed by a biopsy squamous cell carcinoma.
✓P16 positive or negative tumours
✓Index cancer treated with TORS with or without after surgery therapy.

Who cannot take part

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

See the full 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 Is This Study? (1 UK site)

The Royal Marsden Hospital NHS Foundation Trust

London, United Kingdom

Recruiting

Site contact (verified)

Andrew WilliamsonRESCUE@rmh.nhs.uk

How to Get in Touch

Andrew Williamson

Sponsor contact

CONTACT

02000000000 andrew.williamson2@rmh.nhs.uk

Reyhaneh Sadegh Zadeh

Sponsor contact

CONTACT

02000000000 reyhaneh.sadeghzadeh@rmh.nhs.uk

Data sourced from ClinicalTrials.gov · Last verified: 2024-08