Clinical trial 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
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Head and Neck Cancer
Lead sponsor: Royal Marsden NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: Biomedical Research Centre
name: Oracle Cancer Trust
First posted: 2020-12-17
Enrollment: 20
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: OTHER
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Identification of resistant sub clones in post radiotherapy tumour samples
timeFrame: Within 1 year of surgery & receipt of blood/saliva and tissue samples
Secondary outcomes:
measure: Identification of differences in sub clonal architecture of H&N SCC before and after radiotherapy.
timeFrame: Within 1 year of surgery & receipt of blood/saliva and tissue samples
measure: Identification of differences in mutational signatures between the primary disease and resistant sub clones.
timeFrame: Within 1 year of surgery & receipt of blood/saliva and tissue samples
measure: Identification of loss of heterozygosity at the HLA loci in resistant sub clones
timeFrame: Within 1 year of surgery & receipt of blood/saliva and tissue samples
measure: Disease-specific and overall survival at 5 years related to identified molecular characteristics.
timeFrame: 5 years following the date of surgery of the final participant recruited.
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: The Royal Marsden Hospital
Study officials:
affiliation: The Royal Marsden Hospital NHS Foundation Trust
name: Prof Vinidh Paleri
role: PRINCIPAL_INVESTIGATOR
References: