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Colon and Rectal Cancer Trials Open to Recruitment

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Colorectal Cancer trials that are open to recruitment: Beyond TME, TRIGGER, IMPRESS, MINSTREL and SERENADE. Details of entry, endpoints, and contact details for trial workshops

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Colon and Rectal Cancer Trials Open to Recruitment

  1. 1. gina.brown@rmh.nhs.uk Colorectal GI Cancer Imaging Trials Recruiting Contact details if interested in joining trials: Professor Gina Brown Gina.brown@rmh.nhs.uk
  2. 2. The Royal Marsden Notes for NHS Costings • Interventional and non internventional trials: attract Local Network CRN funding per patient recruited to enable support payment of clinical research nurses/ local trial coordination/research radiographer (the PI or Trust receives the funding to pay such costs) • The interventional trials eg SERENADE, Beyond TME, MINSTREL and IMPRESS will attract greater funding £600-700 per patient and TRIGGER a higher amount as an IMP trial • Any imaging including any workshop training for trials is funded in accordance with the NHS Accord agreement as treatment costs or excess treatment costs– no additional funding is required to participate. • No separate applications for funding approval are required as all trials listed here are on the national CSP portfolio and all treatment plus excess treatment costs must automatically attract the necessary funding.
  3. 3. The Royal Marsden MRI criteria and clinical trials • Tumours extending to or beyond TME plane – Beyond TME and TRIGGER trials • EMVI positive tumours for preoperative CRT: Serenade, Marvel and TRIGGER trial • T3c/T3d/T4 tumours for preoperative CRT: TRIGGER trial • >2cm and <5cm endoscopic benign polyp/suspected polyp cancer: MINSTREL trial • Tumours above 15cm or pelvic sigmoid: IMPRESS trial
  4. 4. The Royal Marsden MRI Trials and the Colorectal Patient Pathway
  5. 5. The Royal Marsden • Rectal polyps should be excised with clear margins where possible • Currently there is no recognised, relatively user independent, readily available imaging tool that can reliably asses depth of invasion • Such an imaging tool may standardise management and assist clinicians in choosing the appropriate excision technique
  6. 6. The Royal Marsden • Prospective diagnostic accuracy study open on the UK CRN portfolio. • Sponsored by RMH and supported with a grant from the Pelican Foundation • Target recruitment 55 patients across more than 5 sites over 18 months • Test utility of MRI in identifying levels of invasion in benign and malignant rectal polyps 20mm to 50mm in size up to 150mm from anal verge. • Novel study population using a novel staging tool that highlights boundaries relevant to clinical practice • We recruit from endoscopy and all patients sent for an MRI scan. Unlikely to change treatment pathway for the vast majority of participants.
  7. 7. The Royal Marsden • Inclusion 20mm to 50mm polyp within 150mm of anal verge • Exclusion Polyp excised before MRI Multiple polyps fulfilling the criteria Polyp recurrence Non adenoma or carcinoma Declines study consent Prisoners Contraindication to MRI • Withdrawal No Histopathology available / DXT Cannot tolerate MRI Withdraws consent
  8. 8. The Royal Marsden
  9. 9. The Royal Marsden Beyond TME The role of MRI in improving outcomes and surgical approaches for locally extensive primary or recurrent rectal cancer • (An interventional trial for patients with confirmed primary locally advanced or recurrent rectal cancer beyond the TME plane • The primary endpoint is to demonstrate that a histopathological complete resection with clear margin rate (R0) of >greater than 67% can be achieved using MRI compartmental classification planned exenterative surgery. • Prospective validation of published MRI compartment staging system • Evaluation of pathway healthcare costs and quality of life and survival outcomes for all patients with colorectal cancers that extend beyond the TME plane
  10. 10. The Royal Marsden Beyond TME Inclusion Criteria: • Male or female, 18 years of age or older • Patients with confirmed primary locally advanced or recurrent rectal cancer who require surgery beyond the TME planes (ie multivisceral resection, sacrectomy etc) Data to be collected: MRI assessment Surgery Histopathology Quaity of life Survival outcomes
  11. 11. The Royal Marsden IMPRESS Improving radical treatment through MRI evaluation of pelvic sigmoid cancers • Randomises patients with Sigmoid Cancer to either have a preoperative MRI or not. The aim of the trial is to measure the difference in proportion of patients undergoing radical treatment between the two arms, as well as mortality/morbidity and Quality of Life • Hypothesis: accurate preoperative imaging will improve recurrence rate and survival rates through: Better surgical decision making Selective preoperative therapy (eg Foxtrot trial, or preop CRT) in high risk patients to downsize tumour
  12. 12. High risk featuresHigh risk features • Tumour involving non peritonealisedTumour involving non peritonealised fascial marginfascial margin • Tumour penetration of adjacentTumour penetration of adjacent organsorgans • 4 or more involved nodes4 or more involved nodes • Extramural venous invasionExtramural venous invasion • Depth of extramural spread >5mmDepth of extramural spread >5mm
  13. 13. The Royal Marsden IMPRESS Inclusion Criteria: • All patients with pelvic sigmoid colon adenocarcinoma (demonstrated on colonoscopy and biopsy) who are eligible for curative treatment. • Patients can be selected at colonoscopy if the tumour is above 15cm or on CT if tumour is above 15cm from the anal verge and below the iliac crest.
  14. 14. The Royal Marsden IMPRESS Flow Chart
  15. 15. The Royal Marsden SERENADE Screening for synchronous metastases in colorectal cancer using Hepatic Diffusion weighted MRI • Study aims to see whether a short pre-operative Diffusion Weighted MRI of the liver finds more liver metastases than standard CT alone. • Eligible patients have high risk colorectal cancer and a CT which is negative or does not confirm the presence of metastatic disease. The trial is not randomised – everyone who is in the trial gets the liver DW-MRI. Patients with rectal cancer who are having radiotherapy get the DWMRI as part of their post CRT MR Scan.
  16. 16. The Royal Marsden SERENADE Inclusion Criteria: • Patient aged over 18 years • High risk primary colorectal cancer as determined by pre-operative staging (MRI/CT) • CT negative or no confirmatory evidence of metastatic disease
  17. 17. The Royal Marsden SERENADE Flow Charts
  18. 18. The Royal Marsden TRIGGER Magnetic Resonance Tumour Regression Grade (mrTRG) As A Novel Biomarker To Stratify Management Of Good And Poor Responders To Chemoradiotherapy: A Rectal Cancer Multicentre Randomised Control Trial • Current recommendations are not to use the post- treatment MRI for decision-making but to plan treatment using the baseline (pre-treatment) MRI • TRIGGER uses the post-treatment MRI to stratify treatment
  19. 19. The Royal Marsden TRIGGER • Recently an MRI based tumour regression grade (mrTRG) has been shown to stratify between tumours that respond well and those that respond poorly to CRT. • ‘Good responders’ (mrTRG1&2) appear to have an excellent prognosis and it may be possible to avoid surgery altogether in this group. ‘Poor responders’ (mrTRG3-5) are at high risk of a poor oncological outcomes and additional therapy before surgery may improve their prognosis.
  20. 20. The Royal Marsden TRIGGER Flow Chart
  21. 21. The Royal Marsden TRIGGER • For sites wishing to run a ‘deferral of surgery’ protocol for patients with a complete response following CRT, the TRIGGER trial will provide the necessary radiological training and trial support to make this possible • Currently in the process of being approved, we are seeking expressions of interest from sites, interested in taking part in the TRIGGER feasibility study so please get in touch
  22. 22. The Royal Marsden Summary • All trials on the UKCRN Portfolio • All multi-centre • If you wish to join please contact: Lisa Scerri, Senior Trial Coordinator lisa.scerri@rmh.nhs.uk and she will guide you through the next steps.

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