Rectal CancerNCT04098471
Total Meso-rectal Excision Versus Transanal Local Excision Followed by Radiotherapy for T2N0M0 Distal Rectal Cancer
A study testing transanal local excision following radiotherapy and TME in people with Rectal Cancer, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial summary
A randomized controlled clinical trial to compare the short and long term outcomes of transanal endoscopic microsurgery following radiotherapy or total mesorectal excision for the treatment of Rectal Cancer Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- transanal local excision following radiotherapy and TME
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2021to 1 Jun 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 75 years.
- Histologically confirmed adenocarcinoma by preoperative biopsy.
- Tumor located within 4 cm from the anal verge, confirmed by at least one of the following methods: digital rectal examination, pelvic magnetic resonance imaging (MRI), or colonoscopy.
- Tumor size ≤3 cm, without fixation and with preserved mobility on clinical examination.
- Clinical stage T2 rectal cancer confirmed by preoperative high-resolution pelvic MRI.
- No radiological evidence of suspicious lymph node metastasis or distant metastasis on preoperative contrast-enhanced computed tomography (CT) and MRI.
- Ability to provide written informed consent.
Who cannot join
- History of other malignant tumors within the past 5 years.
- Poorly differentiated adenocarcinoma, mucinous adenocarcinoma, or signet ring cell carcinoma confirmed by pathological examination.
- Multiple primary colorectal tumors.
- Pregnant or breastfeeding women.
- Patients with plans for pregnancy.
- Severe psychiatric disorders.
Show all 11Show fewer
- Previous treatment for rectal cancer, including radiotherapy or chemotherapy.
- Concomitant intestinal diseases, including familial adenomatous polyposis (FAP), hereditary nonpolyposis colorectal cancer (HNPCC), active ulcerative colitis, or Crohn's disease.
- Poor general condition or uncontrolled serious comorbidities that may affect study participation or treatment.
- Contraindications to laparoscopic surgery, including extensive intra-abdominal adhesions caused by previous abdominal surgery or inability to tolerate pneumoperitoneum.
- Current participation in another clinical trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Colorectal Surgery Department, First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu
Yueming Sun
About this study
Official title: Total Mesorectal Excision Versus Transanal Endoscopic Microsurgery Followed by Radiotherapy for T2N0M0 Distal Rectal Cancer: a Multicenter Randomized Trial
A randomized controlled clinical trial to compare the short and long term outcomes of transanal endoscopic microsurgery following radiotherapy or total mesorectal excision for the treatment of Rectal Cancer
Read the detailed description
Rectal cancer is one of the most common malignancy worldwide. Currently, surgery is the main treatment for stage I rectal cancer, which has good therapeutic effect. For ultra-low rectal cancer, transanal endoscopic microsurgery (TEM) has many advantages over total mesorectal excision (TME), such as less trauma, shorter hospitalization time, lower incidence of complications, protection of sexual function and protection of anal function. At present, transanal local excision has become the recommended operation for the T1N0M0 rectal cancer. However, the risk of lymph node metastasis still occurs in stage I tumors, especially in stage T2 tumors, the lymph node metastasis rate can reach 12% - 29% according to the literature. Salvage TME or chemoradiotherapy should be considered for the presence of positive margin of incision, lymphatic/vascular invasion and poor histological differentiation after transanal local excision. At present, the investigators have consulted a large number of literatures and found that TEM is still lack of sufficient evidence in the treatment of T2N0M0 ultra-low rectal cancer. Some studies believed that local excision combined with adjuvant therapy is safe and reliable, but the evidence is not enough. For ultra-low T2N0M0 rectal cancer, more studies need to be carried out to provide guidance for clinical treatment.
In this study, eligible patients will be randomly allocated to operative operation for rectal cancer either by TEM following radiotherapy or TME. 3-years local recurrence rate, 3-years disease free survival rate and 3-years overall survival rate，and postoperative quality of life will be recorded. Patients will be followed up every 3 months for 2 year, every 6 months for 3 years postoperatively to study the long term effects.
- Conditions
- Rectal Cancer
- Being tested
- transanal local excision following radiotherapy, TME
- Keywords
- transanal endoscopic microsurgery, T2N0M0
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transanal local excision following radiotherapyProcedure or surgery
transanal local excision following radiotherapy
TMEProcedure or surgery
Total mesorectal excision
| Study group | Role | What they receive |
|---|---|---|
| transanal endoscopic microsurgery followed by radiotherapy | Experimental | Not described Receives: Procedure: transanal local excision following radiotherapy |
| total mesorectal excision | Active comparator | Not described Receives: Procedure: TME |
What is being measured
The primary outcome is the main question the study is designed to answer.
local recurrance rate
Measured: 3 years
Secondary outcomes (14)
3-years overall survival rate
Measured: 3 years
3-year disease-free survival
Measured: 3 years
3-year mortality rate
Measured: 3 years
postoperative quality of life
Measured by Quality of Life Questionnaire "EORTC QLQ-C30 (version 3)"
Measured: 30 days
complication rate
Measured: 30 days
perioperative mortality
Measured: 30 days
R0 resection rate
Measured: 7 days
operative time
Measured: 7 days
Intraoperative blood loss
Measured: 7 days
colostomy rate
Measured: 7 days
intraoperative blood transfusion
Measured: 7 days
intestinal exhaust time
Measured: 7 days
postoperative pain
Postoperative pain was assessed by numerical rating scale (NRS). The pain level is divided into 0 to 10 points, with higher scores indicating stronger pain. 0 point represented painless, 10 point represented severe pain.
Measured: 30 days after treatment
hospital stay
Measured: 30 days after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2019
- Study start1 Oct 2021
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 168 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yueming Sun, The First Affiliated Hospital with Nanjing Medical University
- Investigators
- Yueming Sun, PhD, Study director, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04098471
- Sponsor's protocol ID
- CRSYM201909
- Status last verified
- Jan 2026
- First submitted
- 19 Sep 2019
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tang J, Zhang Y, Zhang D, Zhang C, Jin K, Ji D, Peng W, Feng Y, Sun Y. Total Mesorectal Excision vs. Transanal Endoscopic Microsurgery Followed by Radiotherapy for T2N0M0 Distal Rectal Cancer: A Multicenter Randomized Trial. Front Surg. 2022 Feb 1;9:812343. doi: 10.3389/fsurg.2022.812343. eCollection 2022.
PubMed 35178428
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Total Mesorectal Excision Versus Transanal Endoscopic Microsurgery Followed by Radiotherapy for T2N0M0 Distal Rectal Cancer: a Multicenter Randomized Trial
- ClinicalTrials.gov ID
- NCT04098471
- Acronym / sponsor ID
- CRSYM201909
- Conditions
- Rectal Cancer
- Keywords
- transanal endoscopic microsurgery, T2N0M0
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 168 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Jun 2030 (estimated)
- First posted
- 23 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A randomized controlled clinical trial to compare the short and long term outcomes of transanal endoscopic microsurgery following radiotherapy or total mesorectal excision for the treatment of Rectal Cancer
Detailed description
Rectal cancer is one of the most common malignancy worldwide. Currently, surgery is the main treatment for stage I rectal cancer, which has good therapeutic effect. For ultra-low rectal cancer, transanal endoscopic microsurgery (TEM) has many advantages over total mesorectal excision (TME), such as less trauma, shorter hospitalization time, lower incidence of complications, protection of sexual function and protection of anal function. At present, transanal local excision has become the recommended operation for the T1N0M0 rectal cancer. However, the risk of lymph node metastasis still occurs in stage I tumors, especially in stage T2 tumors, the lymph node metastasis rate can reach 12% - 29% according to the literature. Salvage TME or chemoradiotherapy should be considered for the presence of positive margin of incision, lymphatic/vascular invasion and poor histological differentiation after transanal local excision. At present, the investigators have consulted a large number of literatures and found that TEM is still lack of sufficient evidence in the treatment of T2N0M0 ultra-low rectal cancer. Some studies believed that local excision combined with adjuvant therapy is safe and reliable, but the evidence is not enough. For ultra-low T2N0M0 rectal cancer, more studies need to be carried out to provide guidance for clinical treatment.
In this study, eligible patients will be randomly allocated to operative operation for rectal cancer either by TEM following radiotherapy or TME. 3-years local recurrence rate, 3-years disease free survival rate and 3-years overall survival rate，and postoperative quality of life will be recorded. Patients will be followed up every 3 months for 2 year, every 6 months for 3 years postoperatively to study the long term effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| transanal endoscopic microsurgery followed by radiotherapy | Experimental | Procedure: transanal local excision following radiotherapy |
| total mesorectal excision | Active comparator | Procedure: TME |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age between 18 and 75 years.
- Histologically confirmed adenocarcinoma by preoperative biopsy.
- Tumor located within 4 cm from the anal verge, confirmed by at least one of the following methods: digital rectal examination, pelvic magnetic resonance imaging (MRI), or colonoscopy.
- Tumor size ≤3 cm, without fixation and with preserved mobility on clinical examination.
- Clinical stage T2 rectal cancer confirmed by preoperative high-resolution pelvic MRI.
Key exclusion criteria (11 listed)
- History of other malignant tumors within the past 5 years.
- Poorly differentiated adenocarcinoma, mucinous adenocarcinoma, or signet ring cell carcinoma confirmed by pathological examination.
- Multiple primary colorectal tumors.
- Pregnant or breastfeeding women.
- Patients with plans for pregnancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| transanal local excision following radiotherapytransanal local excision following radiotherapy | Procedure or surgery | transanal endoscopic microsurgery followed by radiotherapy |
| TMETotal mesorectal excision | Procedure or surgery | total mesorectal excision |
Primary outcome
local recurrance rate
Time frame: 3 years
14 secondary outcomes
3-years overall survival rate
Time frame: 3 years
3-year disease-free survival
Time frame: 3 years
3-year mortality rate
Time frame: 3 years
postoperative quality of life
Time frame: 30 days
complication rate
Time frame: 30 days
perioperative mortality
Time frame: 30 days
R0 resection rate
Time frame: 7 days
operative time
Time frame: 7 days
Intraoperative blood loss
Time frame: 7 days
colostomy rate
Time frame: 7 days
intraoperative blood transfusion
Time frame: 7 days
intestinal exhaust time
Time frame: 7 days
postoperative pain
Time frame: 30 days after treatment
hospital stay
Time frame: 30 days after treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
- Derived from this study: PubMed 35178428Tang J, Zhang Y, Zhang D, Zhang C, Jin K, Ji D, Peng W, Feng Y, Sun Y. Total Mesorectal Excision vs. Transanal Endoscopic Microsurgery Followed by Radiotherapy for T2N0M0 Distal Rectal Cancer: A Multicenter Randomized Trial. Front Surg. 2022 Feb 1;9:812343. doi: 10.3389/fsurg.2022.812343. eCollection 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yueming Sun, PhD study director
The First Affiliated Hospital with Nanjing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transanal local excision following radiotherapy and TME in people with Rectal Cancer, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yueming Sun, PhD (02568306026, jssym@vip.sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
local recurrance rate (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04098471, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2026.