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

Head and Neck Cancer Clinical Trial

— RECUT Plus  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04671940
• Other study ID #: CCR 5263
• Status: Recruiting
• Start date: November 18, 2020
• Est. completion date: October 7, 2026

Study information

• Verified date: May 2024
• Source: Royal Marsden NHS Foundation Trust
• Contact: John C Hardman, MBChB
• Phone: 442073528171
• Email: johncharles.hardman[@]nhs.net
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: October 7, 2026
• Est. primary completion date: October 7, 2026
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Head and Neck Cancer
• Recurrence

Intervention

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

Locations

Country	Name	City	State
United Kingdom	The Royal Marsden Hospital	London

Sponsors (3)

Lead Sponsor	Collaborator
Royal Marsden NHS Foundation Trust	Biomedical Research Centre, Oracle Cancer Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identification of resistant sub clones in post radiotherapy tumour samples	Identification of resistant sub clones in post radiotherapy tumour samples	Within 1 year of surgery & receipt of blood/saliva and tissue samples
Secondary	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.	Within 1 year of surgery & receipt of blood/saliva and tissue samples
Secondary	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.	Within 1 year of surgery & receipt of blood/saliva and tissue samples
Secondary	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	Within 1 year of surgery & receipt of blood/saliva and tissue samples
Secondary	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.	5 years following the date of surgery of the final participant recruited.