Exploratory Study of Clonal Evolution in Cancer for Patients Undergoing Transoral Robotic Surgery for Radiation Exposed Residual/reCurrent Tumours of the Upper Aerodigestive Tract

NCT04671940 | Recruiting

• 1 other identifier: CCR 5263
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Head and Neck Cancer

Outcome Measures

Primary Outcomes (1)

• Identification of resistant sub clones in post radiotherapy tumour samples

  Identification of resistant sub clones in post radiotherapy tumour samples

  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.

  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.

  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

  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.

  5 years following the date of surgery of the final participant recruited.

Study Arms (2)

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.

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

Other: DNA Analysis

Interventions

DNA Analysis OTHER

Molecular analysis includes DNA analysis on the blood/saliva and on the cancer specimens from the biopsies \& subsequent resections

Prospective Cohort; Retrospective Cohort

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing transoral robotic surgery for radiation exposed residual/recurrent/new primary tumours of the upper aerodigestive tract.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Royal Marsden NHS Foundation Trust: lead
• Biomedical Research Centre: collaborator
• Oracle Cancer Trust: collaborator

Study Sites (1)

The Royal Marsden Hospital

London, SW3 6JJ, United Kingdom

RECRUITING

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Officials

• Prof Vinidh Paleri

  The Royal Marsden Hospital NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vishak C Muraleedharan Shylaja, MBChB

CONTACT

442073528171; vishak.muraleedharanshylaja@rmh.nhs.uk

Sarah Burton

CONTACT

020 8661 3567; sarah.burton@rmh.nhs.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2020
• First Posted: December 17, 2020
• Study Start: November 18, 2020
• Primary Completion (Estimated): October 7, 2026
• Study Completion (Estimated): October 7, 2026
• Last Updated: February 12, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)