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 volunteersQualifiers
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
Cohort
Other
Treatments tested in this trial
DNA Analysis
Other interventionMolecular analysis includes DNA analysis on the blood/saliva and on the cancer specimens from the biopsies \& subsequent resections
Treatment groups
Trial outcomes
Primary outcomes
Identification of resistant sub clones in post radiotherapy tumour samples
Identification of resistant sub clones in post radiotherapy tumour samples
Secondary outcomes
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.
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.
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
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.
Sponsors and contacts
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Royal Marsden NHS Foundation Trust
Lead sponsor
Biomedical Research Centre
Collaborator
Oracle Cancer Trust
Collaborator