rectal cancer
Conditions
Interventions
Three arm (1:1:1) randomisation using the following arms:
1. Standard TME surgery (control)
2. Organ saving using:
a. long course concurrent chemoradiation
b. short course radiotherapy
For organ-prese
Sponsors
Radboud Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Biopsy proven adenocarcinoma of the rectum • MRI T1-3b N0 M0 rectal tumour • MDT determines that the following treatment options are all reasonable and feasible: (a) TME surgery, (b) CRT, (c) SCPRT and (d) TEM • Estimated creatinine clearance >50 ml/min
Exclusion criteria
Exclusion criteria: • MRI node positive (defined by protocol guidelines) • MRI extramural vascular invasion (mriEMVI) present (defined by protocol guidelines) • MRI defined mucinous tumour • Mesorectal fascia threatened by tumour ( 40mm; measured from everted edges on sagittal MRI • Anterior tumour location above the peritoneal reflection on MRI or ERUS • No residual luminal tumour following endoscopic mucosal resection • Prior pelvic radiotherapy • Regional or distant metastases • Age
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Year 1: randomise at least 4 cases per month internationally (n=48); 2. Year 2: randomise at least 6 cases per month internationally (n=72). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Can one international partner procure independent funding in year 1? 2. Can one international partner open the study to recruitment in year 1? 3. Organ saving rate in the experimental arms at 12 months (from randomisation) 4. Proportion of patients undergoing TME surgery accurately staged and satisfying inclusion/ exclusion criteria 5. Proportion of patients identified by MRI suitable for active monitoring based on mrTRG assessment 6. 3 year pelvic failure rate defined as the proportion of patients in each arm with: a. unresectable pelvic tumor b. pelvic tumour requiring beyond TME surgery c. | — |
Countries
Netherlands
Outcome results
None listed