Download - Trigger Rectal Cancer Trial Protocol
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mrTRG as a predictor for DFS
mrTRG vs DFSypT vs DFS
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Royal Marsden database n=208 irradiated patients
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Hypothesis
Treatment stratification according to an MRI response biomarker improve survival and
enhance quality of life after chemoradiotherapy in patients with rectal cancer.
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Patient Benefits• First trial to stratify patients into ‘good’ and ‘poor’
chemoradiotherapy responders.
• Good responders - ? Avoid surgery, or less radical surgery
• Poor responders – improve survival
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Trial DesignMulticentre blinded randomised control trial
mrTRG based stratification in intervention armInclusion:
• Adenocarcinoma 0-15cm from anal verge (radiologically)• Deemed to required CRT by recruiting trial centre
Exclusion:• Metastatic disease• MRI or Chemoradiotherapy contraindications• Previous pelvic malignancy, breast feeding or pregnant• Secondary concomitant malignancy
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1) Biopsy - adenocarcinoma
2) Baseline MRI3) Chemoradiotherapy†
4) Eligible & Consent
Intervention arm
Repeat MRI and REASSESS (mrTRGa)
Control arm
mrTRG III-VmrTRG I&II
Good Response Poor Response
Repeat MRI*
Rectal Cancer
Clinical assessmentand baseline MRI
1:2 Randomisation‡
FOLFOX††
24 weeks
Adjuvant Therapy
FOLFOX††
24 weeks
Adjuvant Therapy
Deferral of surgery** Surgery
Repeat MRI (mrTRGb)
FOLFOX 12 weeks
Surgery
FOLFOX 12 weeks
†Recommended CRT regimen – 45Gy/25# and Capecitabine††Recommended post-treatment regime – FOLFOX regimen‡Randomise following MRI assessment but before the MRI is report at the MDT.*MRI to assesses disease progression only** TME surgery if patient declines deferral of surgery mrTRGa - performed at 6 weeks post-CRT mrTRGb - performed 12 weeks into ‘up-front’ FOLFOX treatment
TRIGGER Trial
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EndpointsPrimary Endpoint – 1 year and 3 year QALY•Feasibility
recruit 100 patients, reflecting adequate safety, accurate radiology assessment (Kappa 0.7), patient and clinician equipoise
•Secondary Outcomes: Overall Survival, DFS Stoma free survival pTRG – can ‘upfront’ pre-operative chemotherapy improve pathological
evidence of response health economic evaluation – we anticipate the intervention arm will be
cheaper because it is possible to avoid surgery altogether in at least ¼ of these patients.
Quality of Life Adverse event reporting - CTCAE for surgical and therapeutic TUMOUR BIOLOGY – mrTRG1&2 v mrTRG3-5
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1) Biopsy - adenocarcinoma
2) Baseline MRI3) Chemoradiotherapy†
4) Eligible & Consent
Intervention arm
Repeat MRI and REASSESS (mrTRGa)
Control arm
mrTRG III-VmrTRG I&II
Good Response Poor Response
Repeat MRI*
Rectal Cancer
Clinical assessmentand baseline MRI
1:2 Randomisation‡
FOLFOX††
24 weeks
Adjuvant Therapy
FOLFOX††
24 weeks
Adjuvant Therapy
Deferral of surgery** Surgery
Repeat MRI (mrTRGb)
FOLFOX 12 weeks
Surgery
FOLFOX 12 weeks
†Recommended CRT regimen – 45Gy/25# and Capecitabine††Recommended post-treatment regime – FOLFOX regimen‡Randomise following MRI assessment but before the MRI is report at the MDT.*MRI to assesses disease progression only** TME surgery if patient declines deferral of surgery mrTRGa - performed at 6 weeks post-CRT mrTRGb - performed 12 weeks into ‘up-front’ FOLFOX treatment
TRIGGER Trial