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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Page 1 of 3 (10 locations)

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