Can we Save the rectum by watchful waiting or TransAnal microsurgery following (chemo)Radiotherapy versus Total mesorectal excision for early Rectal Cancer? - STAR-TREC study

Phase 2

Recruiting

Conditions: rectal cancer
10017991

Registration Number: NL-OMON47279

Lead Sponsor: Radboud Universitair Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 75

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

• 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 (<= 1mm on MRI)
• Maximum tumour diameter > 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 <16 years (UK), <18 years (Netherlands/ Denmark)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>1. Year 1: randomise at least 4 cases per month internationally (n=48);<br /><br>2. Year 2: randomise at least 6 cases per month internationally (n=72).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1. Can one international partner procure independent funding in year 1?<br /><br>2. Can one international partner open the study to recruitment in year 1?<br /><br>3. Organ saving rate in the experimental arms at 12 months (from randomisation)<br /><br>4. Proportion of patients undergoing TME surgery accurately staged and<br /><br>satisfying inclusion/ exclusion criteria<br /><br>5. Proportion of patients identified by MRI suitable for active monitoring<br /><br>based on mrTRG assessment<br /><br>6. 3 year pelvic failure rate defined as the proportion of patients in each arm<br /><br>with:<br /><br>a. unresectable pelvic tumor<br /><br>b. pelvic tumour requiring beyond TME surgery<br /><br>c. <=1mm circumferential resection margin after TME surgery<br /><br>7. Overall survival<br /><br>8. Stoma free survival<br /><br>9. Health Related Quality of Life (HR QoL)</p><br>