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

Recruiting

• Conditions: Head and Neck Cancer

• Registration Number: NCT04671940
• Lead Sponsor: Royal Marsden NHS Foundation Trust

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-11-18
• Study First Submitted: 2020-12-11
• Study First Submitted QC: 2020-12-16
• Study First Posted: 2020-12-17
• Status Verified: 2025-08
• Last Update Submitted: 2025-08-07
• Last Update Posted: 2025-08-08
• Primary Completion: 2026-10-07
• Study Completion: 2026-10-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Identification of resistant sub clones in post radiotherapy tumour samples	Within 1 year of surgery & receipt of blood/saliva and tissue samples	Identification of resistant sub clones in post radiotherapy tumour samples

Secondary Outcome Measures

Name	Time	Method
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	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.	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.
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 differences in mutational signatures between the primary disease and resistant sub clones.
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 sub clonal architecture of H\&N SCC before and after radiotherapy.

Trial Locations

Locations (1)

The Royal Marsden Hospital; 🇬🇧 London, United Kingdom