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NCT Number: NCT05933889

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

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

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Key information

Conditions

Cancer Head Neck Head and Neck Neoplasms Margins of Excision Morphological and Microscopic Findings Neoplasm Recurrence, Local Neoplasms Neoplasms by Site Neoplastic Processes Oropharyngeal Neoplasms Otorhinolaryngologic Diseases Otorhinolaryngologic Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms Pharyngeal Diseases Pharyngeal Neoplasms Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The Royal Marsden Hospital NHS Foundation Trust

London, United Kingdom

Location status: Recruiting

Location contact

Andrew Williamson

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. To report 2-year locoregional survival outcomes following TORS for primary OPSCC with or without adjuvant therapy

    Time frame: 2 years

    To report 2-year locoregional survival outcomes following TORS for primary OPSCC with or without adjuvant therapy

Secondary outcomes

  1. To report 2-year overall survival outcomes following TORS for primary OPSCC with or without adjuvant therapy.

    Time frame: 2 years

    To report 2-year overall survival outcomes following TORS for primary OPSCC with or without adjuvant therapy.

  2. To report 2-year disease-free survival outcomes following TORS for primary OPSCC with or without adjuvant therapy.

    Time frame: 2 years

    To report 2-year disease-free survival outcomes following TORS for primary OPSCC with or without adjuvant therapy.

  3. To report 2-year disease specific survival outcomes following TORS for primary OPSCC with or without adjuvant therapy.

    Time frame: 2 years

    To report 2-year disease specific survival outcomes following TORS for primary OPSCC with or without adjuvant therapy.

  4. Define the optimum margin cut off required to avoid 2-year locoregional recurrence in primary TORS without adjuvant therapy

    Time frame: 2 years

    Define the optimum margin cut off required to avoid 2-year locoregional recurrence in primary TORS without adjuvant therapy

  5. To report rates of 30-day post-operative mortality

    Time frame: 30 days

    To report rates of 30-day post-operative mortality

  6. To report rates of 30-day post-operative haemorrhage

    Time frame: 30 days

    To report rates of 30-day post-operative haemorrhage

  7. To report rates of 30-day major haemorrhage necessitating surgical intervention

    Time frame: 30 days

    To report rates of 30-day major haemorrhage necessitating surgical intervention

  8. To report long term feeding tube use after primary TORS surgery with and without post-operative radiotherapy

    Time frame: 12 months

    To report the rate of feeding tube use at 12 months post-operatively

  9. To report long term tracheostomy tube use after primary TORS surgery with and without post-operative radiotherapy

    Time frame: 12 months

    To report the rate of tracheostomy tube use at 12 months post-operatively

  10. Identify clinical and pathological factors predictive of 2-year survival outcomes on uni- and multivariate analysis

    Time frame: 2 years

    Identify clinical and pathological factors predictive of 2-year survival outcomes on uni- and multivariate analysis

Other outcomes

  1. Ascertain the differing molecular characteristics between tumours that experience early 2-year local recurrence and those who do not.

    Time frame: 2 years

    Ascertain the differing molecular characteristics between tumours that experience early 2-year local recurrence and those who do not.

  2. Ascertain the changes in circulating tumour DNA levels in patients undergoing primary TORS for early oropharyngeal cancer.

    Time frame: 2 years

    Ascertain the changes in circulating tumour DNA levels in patients undergoing primary TORS for early oropharyngeal cancer.

  3. Correlation of high-risk genetic features with 2 year local recurrence outcomes

    Time frame: 2 years

    Correlation of high-risk genetic features with 2 year local recurrence outcomes

  4. Ascertain CT or MRI radiomic/ or morphological characteristics of tumours that develop 2-year local recurrence.

    Time frame: 2 years

    Ascertain CT or MRI radiomic/ or morphological characteristics of tumours that develop 2-year local recurrence.

  5. Correlation of high-risk radiomic/ or morphological features and local recurrence

    Time frame: 2 years

    Correlation of high-risk radiomic/ or morphological features and local recurrence

Study contacts

Contact information is provided by the study sponsor or research team.

Andrew Williamson

CONTACT

[email protected]

02000000000

Reyhaneh Sadegh Zadeh

CONTACT

[email protected]

02000000000

Sponsors and collaborators

Lead sponsor

Royal Marsden NHS Foundation Trust

Other

Registry information

Official study title

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

Acronym: SCORE

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Jul 6, 2023
Registry last updated
Aug 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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