Condition category
Cancer
Date applied
15/07/2009
Date assigned
09/11/2009
Last edited
06/05/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Mr Simon Bach

ORCID ID

Contact details

The University of Birmingham
Academic Department of Surgery
4th Floor
QE Hospital
Edgbaston
Birmingham
B15 2TH
United Kingdom
+44 121 371 5889
simon.bach@uhb.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

1.0

Study information

Scientific title

Transanal endoscopic microsurgery (TEM) and Radiotherapy in Early rectal Cancer: a randomised phase II feasibility study

Acronym

TREC

Study hypothesis

TREC will determine the feasibility of performing a randomised controlled trial (RCT) of radical total mesorectal excision (TME) surgery (current gold standard) versus short course pre-operative radiotherapy (SCPRT) and delayed local excision at 8 - 10 weeks for T1-2N0M0 rectal cancer defined according to both magnetic resonance imaging (MRI) and endorectal ultrasound (ERUS).

Ethics approval

Not provided at time of registration

Study design

Multicentre randomised open label phase II feasibility study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Early rectal cancer

Intervention

A phase II open, multi-centre randomised controlled trial for patients with early rectal cancer comparing:
1. Conventional TME surgery
2. Short course pre-operative radiotherapy (SCPRT) and delayed local excision with TEM (after an 8 - 10 week interval)

Intervention type

Other

Phase

Phase II

Drug names

Primary outcome measures

Recruitment, measured at 12, 18 and 24 months

Secondary outcome measures

1. Safety:
1.1. 30-day mortality
1.2. 6-month mortality
1.3. Surgical morbidity
1.4. Bowel, bladder and sexual function (measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaires [EORTC QLQ] C29 and C30)
2. Efficacy:
2.1. Histopathological assessment of tumour down-staging according to depth of tumour invasion and the incidence of other high-risk features
2.2. Conversion rates from organ conservation to radical surgery

Overall trial start date

01/12/2009

Overall trial end date

01/12/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. Biopsy proven adenocarcinoma
2. MRI defined stage I rectal cancer (less than or equal to pT2 N0)
3. Endorectal ultrasound defined rectal cancer less than or equal to uT2
4. Patients who have undergone submuscosal excision for a presumed villous adenoma that on histopathological examination contains discrete invasion less than 3 cm diameter
5. Aged 18 or over, either sex

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Target of 46 participants for the pilot phase

Participant exclusion criteria

1. Familial/genetic cancer
2. T3+ or nodal involvement on radiological staging
3. Contraindications to radiotherapy
4. Previous pelvic radiotherapy
5. Metastatic disease
6. Unable or unwilling to provide written informed consent

Recruitment start date

01/12/2009

Recruitment end date

01/12/2011

Locations

Countries of recruitment

United Kingdom

Trial participating centre

The University of Birmingham
Birmingham
B15 2TH
United Kingdom

Sponsor information

Organisation

University of Birmingham (UK)

Sponsor details

Research & Enterprise
Edgbaston
Birmingham
B15 2TT
United Kingdom

Sponsor type

University/education

Website

http://www.bham.ac.uk/

Funders

Funder type

Charity

Funder name

Cancer Research UK (CRUK) (UK)

Alternative name(s)

CRUK

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes