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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age19+
SponsorRoyal Marsden NHS Foundation Trust

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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 population

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

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

  • DNA Analysis

    Other intervention

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

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: Retrospective Cohort1 intervention
Group B: Prospective Cohort1 intervention

Trial outcomes

Primary outcomes

1

Identification of resistant sub clones in post radiotherapy tumour samples

Identification of resistant sub clones in post radiotherapy tumour samples

Time frame
Within 1 year of surgery & receipt of blood/saliva and tissue samples

Secondary outcomes

1

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.

Time frame
Within 1 year of surgery & receipt of blood/saliva and tissue samples
2

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.

Time frame
Within 1 year of surgery & receipt of blood/saliva and tissue samples
3

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

Time frame
Within 1 year of surgery & receipt of blood/saliva and tissue samples
4

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.

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

Other outcomes

Sponsors and contacts

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Royal Marsden NHS Foundation Trust

Lead sponsor

Biomedical Research Centre

Collaborator

Oracle Cancer Trust

Collaborator