Transanal endoscopic microsurgery (TEM) and Radiotherapy in Early rectal Cancer
| ISRCTN | ISRCTN14422743 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14422743 |
| Protocol serial number | 1.0 |
| Sponsor | University of Birmingham (UK) |
| Funder | Cancer Research UK (CRUK) (UK) |
- 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
Plain English summary of protocol
Contact information
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
| Primary study design | Interventional |
|---|---|
| Study design | Multicentre randomised open label phase II feasibility study |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Transanal endoscopic microsurgery (TEM) and Radiotherapy in Early rectal Cancer: a randomised phase II feasibility study |
| Study acronym | TREC |
| Study objectives | 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 |
| Health condition(s) or problem(s) studied | 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(s) |
Recruitment, measured at 12, 18 and 24 months |
| Key secondary outcome measure(s) |
1. Safety: |
| Completion date | 01/12/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 46 |
| Total final enrolment | 55 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/12/2009 |
| Date of final enrolment | 01/12/2011 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
B15 2TH
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | |
| 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 |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
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.
