Transanal endoscopic microsurgery (TEM) and Radiotherapy in Early rectal Cancer
| ISRCTN | ISRCTN14422743 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14422743 |
| Secondary identifying numbers | 1.0 |
- Submission date
- 15/07/2009
- Registration date
- 09/11/2009
- Last edited
- 21/11/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English Summary
Contact information
Mr Simon Bach
Scientific
Scientific
The University of Birmingham
Academic Department of Surgery
4th Floor, QE Hospital
Edgbaston
Birmingham
B15 2TH
United Kingdom
| Phone | +44 121 371 5889 |
|---|---|
| simon.bach@uhb.nhs.uk |
Study information
| Study design | Multicentre randomised open label phase II feasibility study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Transanal endoscopic microsurgery (TEM) and Radiotherapy in Early rectal Cancer: a randomised phase II feasibility study |
| 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(s) | Not provided at time of registration |
| 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 |
| Primary outcome measure | 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 study start date | 01/12/2009 |
| Overall study end date | 01/12/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Target of 46 participants for the pilot phase |
| Total final enrolment | 55 |
| 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 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
- England
- United Kingdom
Study participating centre
The University of Birmingham
Birmingham
B15 2TH
United Kingdom
B15 2TH
United Kingdom
Sponsor information
University of Birmingham (UK)
University/education
University/education
Research & Enterprise
Edgbaston
Birmingham
B15 2TT
England
United Kingdom
| Website | http://www.bham.ac.uk/ |
|---|---|
"ROR" |
https://ror.org/03angcq70 |
Funders
Funder type
Charity
Cancer Research UK (CRUK) (UK)
Private sector organisation / Other non-profit organizations
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- CR_UK, Cancer Research UK - London, CRUK
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/02/2021 | 16/12/2020 | Yes | No |
| Results article | Quality of life | 17/11/2022 | 21/11/2022 | Yes | No |
Editorial Notes
21/11/2022: Publication reference added.
16/12/2020: The following changes have been made:
1. Publication reference added.
2. The total final enrolment number has been added from the reference.
