Cancer Head NeckSCORENCT05933889
Single and Combined Modality Trans-Oral Robotic Surgery in Early Oropharyngeal Cancer
An observational study of Cancer Head Neck, run by Royal Marsden NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Multi-centre retrospective observational cohort study with optional exploratory radiomic study (international) and prospective molecular analysis studies (UK only). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer Head Neck
- What is being tested?
- Molecular Analysis and Radiomic/ Morphological analysis
- How many people
- 250 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 19 Dec 2023to Aug 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients aged 18 years and older diagnosed with early (T1-T2) primary oropharyngeal squamous cell carcinoma, treated with transoral robotic surgery with or without adjuvant therapy.
Who may be able to join
- 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
Show all 10Show fewer
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
The Royal Marsden Hospital NHS Foundation Trust
London
Andrew Williamson, RESCUE@rmh.nhs.uk
About this study
Official 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
Multi-centre retrospective observational cohort study with optional exploratory radiomic study (international) and prospective molecular analysis studies (UK only).
Read the detailed description
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.
- Conditions
- Cancer Head Neck
- Being tested
- Molecular Analysis, Radiomic/ Morphological analysis
- Keywords
- Robotic Surgical Procedures, Margins of Excision, Oropharyngeal neoplasms, Local neoplasm recurrence, Recurrence free survival
- Medical subject headings
- Head and Neck Neoplasms, Margins of Excision, Oropharyngeal Neoplasms, Neoplasm Recurrence, Local
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Molecular AnalysisGenetic
Germline and circulating tumour DNA analysis of buccal/ blood samples and molecular analysis of primary and recurrent tumour tissue samples
Radiomic/ Morphological analysisOther
Radiomic analysis and assessment of morphological features of pre-operative CT/ MRI imaging in patients who have undergone TORS for primary oropharyngeal cancer.
| Study group | Role | What they receive |
|---|---|---|
| Retrospective observational cohort | Retrospective patients undergoing transoral robotic surgery for early stage T1-2 oropharyngeal cancers on or before to 31/12/2021. Data will be collected from medical records. | |
| Exploratory molecular analysis | Consenting prospective patients based in the UK identified will be invited to participate in the exploratory molecular analysis by their usual care team. If agreeable, patients will consent to donation of either blood or buccal swab samples, in addition to archival tissue from their primary, and if relevant, recurrent tissue samples. Receives: Genetic: Molecular Analysis | |
| Radiology/ radiomic analysis | Retrospective patients based in the UK and abroad will have their pre-operative imaging transferred to the RMH radiology department which will undergo radiomic and morphological assessment to ascertain features that put patients at high risk of local recurrence and positive margins. Receives: Other: Radiomic/ Morphological analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
To report 2-year locoregional survival outcomes following TORS for primary OPSCC with or without adjuvant therapy
To report 2-year locoregional survival outcomes following TORS for primary OPSCC with or without adjuvant therapy
Measured: 2 years
Secondary outcomes (10)
To report 2-year overall survival outcomes following TORS for primary OPSCC with or without adjuvant therapy.
To report 2-year overall survival outcomes following TORS for primary OPSCC with or without adjuvant therapy.
Measured: 2 years
To report 2-year disease-free survival outcomes following TORS for primary OPSCC with or without adjuvant therapy.
To report 2-year disease-free survival outcomes following TORS for primary OPSCC with or without adjuvant therapy.
Measured: 2 years
To report 2-year disease specific survival outcomes following TORS for primary OPSCC with or without adjuvant therapy.
To report 2-year disease specific survival outcomes following TORS for primary OPSCC with or without adjuvant therapy.
Measured: 2 years
Define the optimum margin cut off required to avoid 2-year locoregional recurrence in primary TORS without adjuvant therapy
Define the optimum margin cut off required to avoid 2-year locoregional recurrence in primary TORS without adjuvant therapy
Measured: 2 years
To report rates of 30-day post-operative mortality
To report rates of 30-day post-operative mortality
Measured: 30 days
To report rates of 30-day post-operative haemorrhage
To report rates of 30-day post-operative haemorrhage
Measured: 30 days
To report rates of 30-day major haemorrhage necessitating surgical intervention
To report rates of 30-day major haemorrhage necessitating surgical intervention
Measured: 30 days
To report long term feeding tube use after primary TORS surgery with and without post-operative radiotherapy
To report the rate of feeding tube use at 12 months post-operatively
Measured: 12 months
To report long term tracheostomy tube use after primary TORS surgery with and without post-operative radiotherapy
To report the rate of tracheostomy tube use at 12 months post-operatively
Measured: 12 months
Identify clinical and pathological factors predictive of 2-year survival outcomes on uni- and multivariate analysis
Identify clinical and pathological factors predictive of 2-year survival outcomes on uni- and multivariate analysis
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2023
- Study start19 Dec 2023
- Primary completionAug 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cancer Head NeckStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal Marsden NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vinidh Paleri, Principal investigator, Royal Marsden Hospital NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05933889
- Sponsor's protocol ID
- CCR5852
- Other IDs
- CCR5852, IRAS327707
- Acronym
- SCORE
- Status last verified
- Aug 2024
- First submitted
- 14 Jun 2023
- Last updated
- 7 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Hardman JC, Holsinger FC, Brady GC, Beharry A, Bonifer AT, D'Andrea G, Dabas SK, de Almeida JR, Duvvuri U, Floros P, Ghanem TA, Gorphe P, Gross ND, Hamilton D, Kurukulasuriya C, Larsen MHH, Lin DJ, Magnuson JS, Meulemans J, Miles BA, Moore EJ, Pantvaidya G, Roof S, Rubek N, Simon C, Subash A, Topf MC, Van Abel KM, Vander Poorten V, Walgama ES, Greenlay E, Potts L, Balaji A, Starmer HM, Stephen S, Roe J, Harrington K, Paleri V. Transoral Robotic Surgery for Recurrent Tumors of the Upper Aerodigestive Tract (RECUT): An International Cohort Study. J Natl Cancer Inst. 2022 Oct 6;114(10):1400-1409. doi: 10.1093/jnci/djac130.
PubMed 35944904Warner L, O'Hara JT, Lin DJ, Oozeer N, Fox H, Meikle D, Hamilton D, Iqbal MS, Robinson M, Paleri V. Transoral robotic surgery and neck dissection alone for head and neck squamous cell carcinoma: Influence of resection margins on oncological outcomes. Oral Oncol. 2022 Jul;130:105909. doi: 10.1016/j.oraloncology.2022.105909. Epub 2022 May 26.
PubMed 35636080Williamson A, Moen CM, Slim MAM, Warner L, O'Leary B, Paleri V. Transoral robotic surgery without adjuvant therapy: A systematic review and meta-analysis of the association between surgical margins and local recurrence. Oral Oncol. 2023 Dec;147:106610. doi: 10.1016/j.oraloncology.2023.106610. Epub 2023 Nov 9.
PubMed 37951118
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT05933889
- Acronym / sponsor ID
- SCORE / CCR5852
- Conditions
- Cancer Head Neck
- Keywords
- Robotic Surgical Procedures, Margins of Excision, Oropharyngeal neoplasms, Local neoplasm recurrence, Recurrence free survival
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Royal Marsden NHS Foundation TrustUniversity, hospital or other
- Study start
- 19 Dec 2023 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 6 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Multi-centre retrospective observational cohort study with optional exploratory radiomic study (international) and prospective molecular analysis studies (UK only).
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Retrospective observational cohort | – | –Retrospective patients undergoing transoral robotic surgery for early stage T1-2 oropharyngeal cancers on or before to 31/12/2021. Data will be collected from medical records. |
| Exploratory molecular analysis | – | Genetic: Molecular AnalysisConsenting prospective patients based in the UK identified will be invited to participate in the exploratory molecular analysis by their usual care team. If agreeable, patients will consent to donation of either blood or buccal swab samples, in addition to archival tissue from their primary, and if relevant, recurrent tissue samples. |
| Radiology/ radiomic analysis | – | Other: Radiomic/ Morphological analysisRetrospective patients based in the UK and abroad will have their pre-operative imaging transferred to the RMH radiology department which will undergo radiomic and morphological assessment to ascertain features that put patients at high risk of local recurrence and positive margins. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged 18 years and older diagnosed with early (T1-T2) primary oropharyngeal squamous cell carcinoma, treated with transoral robotic surgery with or without adjuvant therapy.
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Molecular AnalysisGermline and circulating tumour DNA analysis of buccal/ blood samples and molecular analysis of primary and recurrent tumour tissue samples | Genetic | Exploratory molecular analysis |
| Radiomic/ Morphological analysisRadiomic analysis and assessment of morphological features of pre-operative CT/ MRI imaging in patients who have undergone TORS for primary oropharyngeal cancer. | Other | Radiology/ radiomic analysis |
Primary outcome
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
10 secondary outcomes
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 disease-free 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.
Time frame: 2 years
Define the optimum margin cut off required to avoid 2-year locoregional recurrence in primary TORS without adjuvant therapy
Time frame: 2 years
To report rates of 30-day post-operative mortality
Time frame: 30 days
To report rates of 30-day post-operative haemorrhage
Time frame: 30 days
To report rates of 30-day major haemorrhage necessitating surgical intervention
Time frame: 30 days
To report long term feeding tube use after primary TORS surgery with and without post-operative radiotherapy
Time frame: 12 months
To report long term tracheostomy tube use after primary TORS surgery with and without post-operative radiotherapy
Time frame: 12 months
Identify clinical and pathological factors predictive of 2-year survival outcomes on uni- and multivariate analysis
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2024.
- Background: PubMed 35944904Hardman JC, Holsinger FC, Brady GC, Beharry A, Bonifer AT, D'Andrea G, Dabas SK, de Almeida JR, Duvvuri U, Floros P, Ghanem TA, Gorphe P, Gross ND, Hamilton D, Kurukulasuriya C, Larsen MHH, Lin DJ, Magnuson JS, Meulemans J, Miles BA, Moore EJ, Pantvaidya G, Roof S, Rubek N, Simon C, Subash A, Topf MC, Van Abel KM, Vander Poorten V, Walgama ES, Greenlay E, Potts L, Balaji A, Starmer HM, Stephen S, Roe J, Harrington K, Paleri V. Transoral Robotic Surgery for Recurrent Tumors of the Upper Aerodigestive Tract (RECUT): An International Cohort Study. J Natl Cancer Inst. 2022 Oct 6;114(10):1400-1409. doi: 10.1093/jnci/djac130.
- Background: PubMed 35636080Warner L, O'Hara JT, Lin DJ, Oozeer N, Fox H, Meikle D, Hamilton D, Iqbal MS, Robinson M, Paleri V. Transoral robotic surgery and neck dissection alone for head and neck squamous cell carcinoma: Influence of resection margins on oncological outcomes. Oral Oncol. 2022 Jul;130:105909. doi: 10.1016/j.oraloncology.2022.105909. Epub 2022 May 26.
- Background: PubMed 37951118Williamson A, Moen CM, Slim MAM, Warner L, O'Leary B, Paleri V. Transoral robotic surgery without adjuvant therapy: A systematic review and meta-analysis of the association between surgical margins and local recurrence. Oral Oncol. 2023 Dec;147:106610. doi: 10.1016/j.oraloncology.2023.106610. Epub 2023 Nov 9.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Vinidh Paleri principal investigator
Royal Marsden Hospital NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer Head Neck, run by Royal Marsden NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andrew Williamson (02000000000, andrew.williamson2@rmh.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To report 2-year locoregional survival outcomes following TORS for primary OPSCC with or without adjuvant therapy (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05933889, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2024.