Status:
RECRUITING
Magnetic Resonance Tumour Regression Grade (mrTRG) as a Novel Biomarker - Phase III Non CTIMP Trial
Lead Sponsor:
Imperial College London
Conditions:
Rectal Cancer
Eligibility:
All Genders
16+ years
Phase:
NA
Brief Summary
Open to patients undergoing any pre-operative treatment for locally advanced rectal cancer, TRIGGER is the only phase III clinical trial in the UK offering watch and wait. All patients will have post ...
Detailed Description
The only phase III clinical trial in the UK offering watch and wait, the TRIGGER trial aims to validate mrTRG as an imaging biomarker for the stratified management of patients with locally advanced re...
Eligibility Criteria
Inclusion
- MRI defined locally advanced rectal carcinoma i.e. one or more: greater than or equal to mrT3c; mrEMVI positive; mr N1c; mr CRM positive
- Biopsy confirmed adenocarcinoma of radiologically defined rectum
- Be deemed to require preoperative chemoradiotherapy (CRT) or total neoadjuvant therapy (TNT)
Exclusion
- Metastatic disease
- MRI, radiotherapy and/or chemotherapy contraindications
- A post-treatment MRI performed more than 10 weeks after the completion of radiotherapy if given
- Previous malignancy within preceding 5 years if risk of recurrence \>5%
Key Trial Info
Start Date :
March 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2036
Estimated Enrollment :
441 Patients enrolled
Trial Details
Trial ID
NCT02704520
Start Date
March 1 2016
End Date
December 1 2036
Last Update
October 17 2024
Active Locations (10)
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1
Aberdeen Royal Infirmary - NHS Grampion
Aberdeen, Aberdeenshire, United Kingdom, AB252ZN
2
Hampshire Hospitals NHS Foundation Trust
Basingstoke, Hampshire, United Kingdom, RG24 9NA
3
University Hospital of North Midlands NHS Trust - Royal Stoke
Stoke-on-Trent, Staffordshire, United Kingdom, ST4 6QS
4
Salisbury NHS Foundation Trust
Salisbury, Wiltshire, United Kingdom, SP2 8BJ