A randomised Phase III feasibility study to compare radical TME surgery versus preoperative (chemo)radiotherapy and watchful waiting or local excision for treatment of early stage rectal cancer.

Phase 3

Recruiting

• Conditions: rectal cancer; 10017991

• Registration Number: NL-OMON55049
• Lead Sponsor: niversity of Birmingham

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 150

Inclusion Criteria

• Biopsy proven adenocarcinoma of the rectum
• MRI <=T3b N0 M0 rectal tumour
• MDT determines that the following treatment options are all reasonable and
feasible: (a) TME surgery, (b) CRT, (c) SCRT and (d) TEM
• ECOG status 0-1

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
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Secondary Outcome Measures

Name	Time	Method
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