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NCT Number: NCT04671940

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.

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.

Recruiting

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The Royal Marsden Hospital

London, SW3 6JJ, United Kingdom

Location status: Recruiting

Location contact

Prof Vinidh Paleri

CONTACT

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

DNA Analysis

Other

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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 sub clonal architecture of H&N SCC before and after radiotherapy.

  2. 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 differences in mutational signatures between the primary disease and resistant sub clones.

  3. 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

    Identification of loss of heterozygosity at the HLA loci in resistant sub clones

  4. 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.

    Disease-specific and overall survival at 5 years related to identified molecular characteristics.

Study contacts

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

Sarah Burton

CONTACT

[email protected]

020 8661 3567

Vishak C Muraleedharan Shylaja, MBChB

CONTACT

[email protected]

442073528171

Sponsors and collaborators

Lead sponsor

Royal Marsden NHS Foundation Trust

Other

Collaborators

  • Biomedical Research Centre
  • Oracle Cancer Trust

Registry information

Official study 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

Acronym: RECUT Plus

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Dec 17, 2020
Registry last updated
Feb 12, 2026

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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