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

Phase 1

• Conditions: Early rectal cancer; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2019-004669-41-NL
• Lead Sponsor: niversity of Birmingham

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-12-16
• Last Update Posted: 6 July 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 350

Inclusion Criteria

Main inclusion criteria
• Biopsy proven adenocarcinoma of the rectum
• Magnetic Resonance Imaging (MRI)- or Endorectal Ultrasound (ERUS)-staged TX/T1-3b, NX/N0, MX/M0 rectal tumour
• MDT determines that the following treatment options are all reasonable and feasible: (a) TME surgery, (b) CRT, (c) SCRT and (d) Transanal Endoscopic Microsurgery (TEM)
• Eastern Cooperative Oncology Group (ECOG) performance status 0-1
• Willing and able to consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 120
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion Criteria

Main exclusion criteria
• Concomitant or previous malignancies within 3 years prior to trial entry, except those that in the opinion of the MDT are unlikely to relapse within 3 years or lead to death within 5 years
• MRI node positive (=N1, 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 or ERUS)
• Maximum tumour diameter >40mm (either measured from everted edges on sagittal MRI or ERUS examination)
• Anterior tumour location above the peritoneal reflection on MRI or ERUS
• No residual luminal tumour following endoscopic mucosal resection
• Prior pelvic radiotherapy
• Definite evidence of regional or distant metastases (M1) in opinion of MDT
• Uncontrolled cardiorespiratory comorbidity (inadequately controlled angina or myocardial infarction or arrhythmia within 6 months prior to trial entry)
• Known Dihydropyrimidine Dehydrogenase deficiency
• Known Gilbert’s disease
• Taking coumarin-derivative oral anticoagulants that cannot be stopped or substituted by low molecular weight heparin
• Taking metronidazole, phenytoin, sorivudine or its analogues, such as brivudine
• Women who are pregnant or lactating Age <16 years (UK), <18 years (other countries)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The phase III component will evaluate two contrasting organ preservation strategies (either long-course chemoradiotherapy or short-course radiotherapy) for the treatment of early stage rectal cancer in terms of organ preservation rates, toxicity (clinician and patient-reported) and Health-Related Quality of Life (HRQoL).<br>The phase III study will also include a standard TME radical surgery (non- randomised) comparator arm encompassing reconstructive (low anterior resection) and non-reconstructive (abdominoperineal excision, low Hartmann’s procedure) approaches.;Secondary Objective: N/A;Primary end point(s): Primary outcome:<br>The proportion of patients with successful organ preservation at 30 months from the start date of (chemo)radiotherapy.<br>Organ preservation is considered to have failed (a) if the rectum is removed; (b) if the patient develops unequivocal locoregional cancer recurrence or (c) if the patient has a stoma.;Timepoint(s) of evaluation of this end point: 30 months