Research with human participants

Overview of medical research in the Netherlands

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.

Published:
Last updated:

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Ethical review
Approved WMO
Status
Recruiting
Health condition type
Gastrointestinal neoplasms malignant and unspecified
Study type
Interventional

ID

NL-OMON55049

Source

ToetsingOnline

Brief title

STAR-TREC

Condition

  • Gastrointestinal neoplasms malignant and unspecified

Synonym

rectal cancer

Research involving

Human

Sponsors and support

Primary sponsor :
University of Birmingham
Source(s) of monetary or material Support :
KWF

Intervention

Keyword :
Chemotherapy, Radiotherapy, Rectal cancer, Surgery

Outcome measures

Primary outcome

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Secondary outcome

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Background summary

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Study objective

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Study design

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Intervention

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Study burden and risks

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Public
University of Birmingham

Research Support Group, Aston Webb Building 119
Birmingham B152TT
GB
Scientific
University of Birmingham

Research Support Group, Aston Webb Building 119
Birmingham B152TT
GB

Listed location countries

Netherlands

Age

Adults (18-64 years)
Elderly (65 years and older)

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)

Design

Study phase :
3
Study type :
Interventional
Intervention model
:
Parallel
Allocation :
Randomized controlled trial
Masking :
Open (masking not used)
Control :
Active
Primary purpose :
Treatment

Recruitment

NL
Recruitment status
:
Recruiting
Start date (anticipated) :
Enrollment :
150
Type :
Actual

Medical products/devices used

Product type :
Medicine
Brand name :
Capecitabine
Generic name :
Capecitabine
Registration
:
Yes - NL intended use

Approved WMO
Date :
Application type :
First submission
Review commission :
CMO regio Arnhem-Nijmegen (Nijmegen)
Approved WMO
Date :
Application type :
First submission
Review commission :
CMO regio Arnhem-Nijmegen (Nijmegen)
Approved WMO
Date :
Application type :
Amendment
Review commission :
CMO regio Arnhem-Nijmegen (Nijmegen)
Approved WMO
Date :
Application type :
Amendment
Review commission :
CMO regio Arnhem-Nijmegen (Nijmegen)
Approved WMO
Date :
Application type :
Amendment
Review commission :
CMO regio Arnhem-Nijmegen (Nijmegen)
Approved WMO
Date :
Application type :
Amendment
Review commission :
CMO regio Arnhem-Nijmegen (Nijmegen)
Approved WMO
Date :
Application type :
Amendment
Review commission :
CMO regio Arnhem-Nijmegen (Nijmegen)
Approved WMO
Date :
Application type :
Amendment
Review commission :
CMO regio Arnhem-Nijmegen (Nijmegen)
Approved WMO
Date :
Application type :
Amendment
Review commission :
CMO regio Arnhem-Nijmegen (Nijmegen)
Approved WMO
Date :
Application type :
Amendment
Review commission :
CMO regio Arnhem-Nijmegen (Nijmegen)

Followed up by the following (possibly more current) registration

No registrations found.

Other (possibly less up-to-date) registrations in this register

No registrations found.

In other registers

Register ID
EudraCT EUCTR2019-004669-41-NL
CCMO NL72230.091.19