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Table 4 Intervention arm – ‘good response’ to chemoradiotherapy

From: A rectal cancer feasibility study with an embedded phase III trial design assessing magnetic resonance tumour regression grade (mrTRG) as a novel biomarker to stratify management by good and poor response to chemoradiotherapy (TRIGGER): study protocol for a randomised controlled trial

Intervention arm – good responders Registration period Intervention phase Follow-up Disease statusg
Visit type Prior to patient entry Registration Randomisation (baseline) Post CRT MDT No surgery Chemotherapy for 24 weeksf Follow surveillance schedule for patients who defer surgery for a period of 5 years from end of chemotherapy (Table 3).
If surgery is undertaken (patient declines deferral of surgery or regrowth is detected during follow-up) then the follow-up schedule for the control arm should be used. The Surgery and Surgical Morbidity CRFs should be completed as per control schedule. In the case of regrowth a Surveillance CRF should also be completed.
10 years
Timelines   ≤4 weeks prior to CRT During CRT 4–6 weeks post CRT Review of restaging MRI including mrTRG reporting. mrTRG-directed management results in option of deferral of surgery (mrTRG I and II). The option of deferral of surgery is discussed with patient ≤12 weeks post CRT. Toxicity assessed at end of each cycle during chemotherapy From end of CRT
Informed consenta   X X    
Check eligibility criteria   X X    
Diagnosis and clinical assessment   X     
Randomisation    X    
Quality of life   X     
Chemoradiotherapy    X    
Blood sampleb   X   X   
Baseline MRI X      
Restaging MRIc     X X  
Chemotherapy      X end of each cycle  
Toxicity assessment      X end of each cycle  
Annual follow-up       X
Adverse eventse     X X end of each cycle  
Concurrent medications   X X X X end of each cycle  
  1. CRT pre-operative chemoradiotherapy, MDT multidisciplinary team, MRI magnetic resonance imaging, mrTRG MRI tumour regression grade
  2. The X also denotes that Clinical Report Forms (CRFs) need completing
  3. aEligible subjects will be asked to provide written informed consent at registration and before randomisation
  4. bIf patient has consented to additional blood sample collection for research
  5. cThe post-CRT MRI should to be performed within 4–6 weeks (maximum of 10 weeks) from completion of CRT. A further MRI should be performed mid-way through chemotherapy treatment at approximately 12 weeks
  6. dResected specimen will be prepared and evaluated using a standardised protocol
  7. eAll adverse events will be recorded from the date the post-CRT MRI scan is performed until 30 days after the last dose of chemotherapy is administered during the intervention phase of the trial
  8. fInitial staging indicated these tumours were locally advanced; therefore, all patients are offered a systemic chemotherapy regimen equivalent to post-operative adjuvant chemotherapy. If regrowth occurs during chemotherapy patient should proceed to surgery and discuss the pathology at MDT to decide if remaining cycles should be given post-operatively
  9. gDisease status at 10 years (does not require clinic visit): alive without metastatic or recurrent disease, alive with metastatic and/or recurrent disease (date diagnosed), dead (date of death)