Head and Neck CancerRECUT PlusNCT04671940
Exploratory Study of Clonal Evolution in Cancer for Patients Undergoing Transoral Robotic Surgery for Radiation Exposed Residual/reCurrent Tumours of the Upper Aerodigestive Tract
An observational study of Head and Neck Cancer, run by Royal Marsden NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Radical radiotherapy for head and neck squamous cell cancer (HNSCC) can be administered to primary disease with curative intent. Residual disease, recurrence or further tumours may subsequently occur in this irradiated field. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- DNA Analysis
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 18 Nov 2020to 7 Oct 2026
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing transoral robotic surgery for radiation exposed residual/recurrent/new primary tumours of the upper aerodigestive tract.
Who may be able to join
- Aged over 18
- Previous H\&N cancer treated with radiotherapy.
- Undergoing TORS as part of their management for residual, recurrent or new primary H\&N cancer.
Who cannot join
- Where TORS is used in a diagnostic setting only
- Nasopharyngeal and thyroid head and neck cancers
- Where no tissue specimens are available from the recurrent/residual/secondary tumour for the retrospective cohort
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
London, SW3 6JJ
Prof Vinidh Paleri
About this study
Official title: RECUT PLUS: Exploratory Study of Clonal Evolution in Cancer for Patients Undergoing Transoral Robotic Surgery for Radiation Exposed Residual/reCurrent Tumours of the Upper Aerodigestive Tract
Radical radiotherapy for head and neck squamous cell cancer (HNSCC) can be administered to primary disease with curative intent. Residual disease, recurrence or further tumours may subsequently occur in this irradiated field. It is unknown whether these cancers reflect primary resistance or represent the evolution of resistance on treatment.
Understanding this could allow stratification of patients to more effective primary treatments, such as transoral robotic surgery, or help tailor systemic therapies for these cancers in previously irradiated fields.
Read more
RECUT+ is an exploratory molecular analysis study to assess the selective impact of radiation therapy on HNSCC.
Participants will be recruited from the Royal Marsden Hospital (RMH), Chelsea, a tertiary referral H\&N cancer unit in London, UK, specialising in transoral robotic surgery.
Retrospective participants will be identified from previous Head and neck MDT lists at RMH.
Prospective participants will be screened for by the RECUT+ team during the weekly H\&N MDT meetings at the Royal Marsden Hospital (RMH).
Blood/saliva samples will be collected pre operatively (prospective participants) and post operatively (retrospective and prospective participants) for germline and circulating tumour DNA analysis.
Biopsy samples from the original cancer and resected specimens from the post radiotherapy residual/recurrent/new primary disease will undergo molecular analysis to assess for any selective impact of radiotherapy on these further tumours.
- Conditions
- Head and Neck Cancer
- Being tested
- DNA Analysis
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DNA AnalysisOther
Molecular analysis includes DNA analysis on the blood/saliva and on the cancer specimens from the biopsies \& subsequent resections
| Study group | Role | What they receive |
|---|---|---|
| Retrospective Cohort | Patients who have previously had radiotherapy and then have had their local residual/recurrent disease managed with salvage TORS at the Royal Marsden Hospital will be eligible for inclusion. They will be informed of the RECUT+ study by a member of their usual care team at RMH during their routine outpatient appointments for follow up of their H\&N cancer.
Potential participants will be asked to consent to provide blood/saliva sample for germline DNA and for permission for their original tumour biopsy sample and their residual/recurrent resection to undergo DNA analysis. Where patients have returned to their referring institution and are no longer under active regular follow up at RMH, a research pack will be sent to the patient via post and email. This pack will contain the Cover Letter, the Participant Information Sheet and the Informed Consent Form. It will also contain a saliva collection tube, buccal swab, blood tubes and instructions for how to provide blood/saliva samples. Receives: Other: DNA Analysis | |
| Prospective Cohort | Patients who have previously had radiotherapy and then are due to have their local residual/recurrent disease managed with salvage transoral robotic surgery at the Royal Marsden Hospital (RMH) will be approached prior to their salvage surgery at a routine outpatient appointment. They will be asked to consent to provide blood/saliva sample for germline DNA pre and post operatively. They will also be asked for permission for their original tumour biopsy sample and their residual/recurrent resection to undergo DNA analysis Receives: Other: DNA Analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of resistant sub clones in post radiotherapy tumour samples
Identification of resistant sub clones in post radiotherapy tumour samples
Measured: Within 1 year of surgery & receipt of blood/saliva and tissue samples
Secondary outcomes (4)
Identification of differences in sub clonal architecture of H&N SCC before and after radiotherapy.
Identification of differences in sub clonal architecture of H\&N SCC before and after radiotherapy.
Measured: Within 1 year of surgery & receipt of blood/saliva and tissue samples
Identification of differences in mutational signatures between the primary disease and resistant sub clones.
Identification of differences in mutational signatures between the primary disease and resistant sub clones.
Measured: Within 1 year of surgery & receipt of blood/saliva and tissue samples
Identification of loss of heterozygosity at the HLA loci in resistant sub clones
Identification of loss of heterozygosity at the HLA loci in resistant sub clones
Measured: Within 1 year of surgery & receipt of blood/saliva and tissue samples
Disease-specific and overall survival at 5 years related to identified molecular characteristics.
Disease-specific and overall survival at 5 years related to identified molecular characteristics.
Measured: 5 years following the date of surgery of the final participant recruited.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2020
- Study start18 Nov 2020
- Primary completion7 Oct 2026 (estimated)
- Study completion7 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by Royal Marsden NHS Foundation TrustThe sponsor's other registered studies.
- 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
- Other
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal Marsden NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Biomedical Research Centre, Oracle Cancer Trust
- Responsible party
- Sponsor
- Investigators
- Prof Vinidh Paleri, Principal investigator, The Royal Marsden Hospital NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04671940
- Sponsor's protocol ID
- CCR 5263
- Acronym
- RECUT Plus
- Status last verified
- Feb 2026
- First submitted
- 11 Dec 2020
- Last updated
- 12 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RECUT PLUS: Exploratory Study of Clonal Evolution in Cancer for Patients Undergoing Transoral Robotic Surgery for Radiation Exposed Residual/reCurrent Tumours of the Upper Aerodigestive Tract
- ClinicalTrials.gov ID
- NCT04671940
- Acronym / sponsor ID
- RECUT Plus / CCR 5263
- Conditions
- Head and Neck Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Royal Marsden NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Biomedical Research Centre, Oracle Cancer Trust
- Study start
- 18 Nov 2020 (actual)
- Primary completion
- 7 Oct 2026 (estimated)
- Study completion
- 7 Oct 2026 (estimated)
- First posted
- 17 Dec 2020 (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.
Radical radiotherapy for head and neck squamous cell cancer (HNSCC) can be administered to primary disease with curative intent. Residual disease, recurrence or further tumours may subsequently occur in this irradiated field. It is unknown whether these cancers reflect primary resistance or represent the evolution of resistance on treatment.
Understanding this could allow stratification of patients to more effective primary treatments, such as transoral robotic surgery, or help tailor systemic therapies for these cancers in previously irradiated fields.
RECUT+ is an exploratory molecular analysis study to assess the selective impact of radiation therapy on HNSCC.
Participants will be recruited from the Royal Marsden Hospital (RMH), Chelsea, a tertiary referral H\&N cancer unit in London, UK, specialising in transoral robotic surgery.
Retrospective participants will be identified from previous Head and neck MDT lists at RMH.
Prospective participants will be screened for by the RECUT+ team during the weekly H\&N MDT meetings at the Royal Marsden Hospital (RMH).
Blood/saliva samples will be collected pre operatively (prospective participants) and post operatively (retrospective and prospective participants) for germline and circulating tumour DNA analysis.
Biopsy samples from the original cancer and resected specimens from the post radiotherapy residual/recurrent/new primary disease will undergo molecular analysis to assess for any selective impact of radiotherapy on these further tumours.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Retrospective Cohort | – | Other: DNA AnalysisPatients who have previously had radiotherapy and then have had their local residual/recurrent disease managed with salvage TORS at the Royal Marsden Hospital will be eligible for inclusion. They will be informed of the RECUT+ study by a member of their usual care team at RMH during their routine outpatient appointments for follow up of their H\&N cancer. Potential participants will be asked to consent to provide blood/saliva sample for germline DNA and for permission for their original tumour biopsy sample and their residual/recurrent resection to undergo DNA analysis. Where patients have returned to their referring institution and are no longer under active regular follow up at RMH, a research pack will be sent to the patient via post and email. This pack will contain the Cover Letter, the Participant Information Sheet and the Informed Consent Form. It will also contain a saliva collection tube, buccal swab, blood tubes and instructions for how to provide blood/saliva samples. |
| Prospective Cohort | – | Other: DNA AnalysisPatients who have previously had radiotherapy and then are due to have their local residual/recurrent disease managed with salvage transoral robotic surgery at the Royal Marsden Hospital (RMH) will be approached prior to their salvage surgery at a routine outpatient appointment. They will be asked to consent to provide blood/saliva sample for germline DNA pre and post operatively. They will also be asked for permission for their original tumour biopsy sample and their residual/recurrent resection to undergo DNA analysis |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing transoral robotic surgery for radiation exposed residual/recurrent/new primary tumours of the upper aerodigestive tract.
Key inclusion criteria (3 listed)
- Aged over 18
- Previous H\&N cancer treated with radiotherapy.
- Undergoing TORS as part of their management for residual, recurrent or new primary H\&N cancer.
Key exclusion criteria (3 listed)
- Where TORS is used in a diagnostic setting only
- Nasopharyngeal and thyroid head and neck cancers
- Where no tissue specimens are available from the recurrent/residual/secondary tumour for the retrospective cohort
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 |
|---|---|---|
| DNA AnalysisMolecular analysis includes DNA analysis on the blood/saliva and on the cancer specimens from the biopsies \& subsequent resections | Other | Prospective Cohort, Retrospective Cohort |
Primary outcome
Identification of resistant sub clones in post radiotherapy tumour samples
Time frame: Within 1 year of surgery & receipt of blood/saliva and tissue samples
Identification of resistant sub clones in post radiotherapy tumour samples
4 secondary outcomes
Identification of differences in sub clonal architecture of H&N SCC before and after radiotherapy.
Time frame: Within 1 year of surgery & receipt of blood/saliva and tissue samples
Identification of differences in mutational signatures between the primary disease and resistant sub clones.
Time frame: Within 1 year of surgery & receipt of blood/saliva and tissue samples
Identification of loss of heterozygosity at the HLA loci in resistant sub clones
Time frame: Within 1 year of surgery & receipt of blood/saliva and tissue samples
Disease-specific and overall survival at 5 years related to identified molecular characteristics.
Time frame: 5 years following the date of surgery of the final participant recruited.
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 12 Feb 2026.
- Individual participant dataSharing planned: No
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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.
Prof Vinidh Paleri principal investigator
The 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 Head and Neck Cancer, 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 3 inclusion and 3 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 12 Feb 2026. 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 Vishak C Muraleedharan Shylaja, MBChB (442073528171, vishak.muraleedharanshylaja@rmh.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of resistant sub clones in post radiotherapy tumour samples (time frame: Within 1 year of surgery & receipt of blood/saliva and tissue samples). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Feb 2026.