Simple Transanal Local Excision，Transanal Local Excision Following Radiotherapy Versus Total Mesorectum Excision for the Treatment of the Ultra-low T2N0M0 Rectal Cancer

A Randomized Controlled Clinical Trial to Investigate the Effects of Transanal Local Excision Following Radiotherapy for the Treatment of Ultra-low T2N0M0 Rectal Cancer

A randomized controlled clinical trial to compare the short and long term outcomes of simple transanal local excision，transanal local excision following radiotherapy or total mesorectal excision for the treatment of Rectal Cancer

Study Overview

• Status: Not yet recruiting
• Conditions: Rectal Cancer
• Intervention / Treatment: Procedure: transanal local excision following radiotherapy

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 local excision (TLE) 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 simple TLE，TLE following radiotherapy or TME. 5-years disease free survival rate, 5-years overall survival rate，local recurrence 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 Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yueming Sun, PhD; Phone Number: 02568306026; Email: jssym@vip.sina.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Preoperative pathology confirmed adenocarcinoma.
2. Preoperative MRI or digital examination of tectum confirmed that the distances from the lower edge of the tumors to the anus were less than 5 cm.
3. The mass is not fixed.
4. Preoperative MRI and rectal EUS indicated that the tumor only invaded muscular layer (T2).
5. No suspicious lymphatic metastasis or distant metastasis was found on preoperative high-resolution CT and MRI.
6. American Society of Anesthesiologists(ASA) grade I-III.
7. Informed consent.
8. No history of familial adenomatous polyposis, ulcerative colitis or Crohn's disease.

Exclusion Criteria:

1. Age<18, or>75.
2. Have other cancer history.
3. The pathology of rectal tumors is non-adenocarcinoma.
4. Multiple primary colorectal tumors.
5. Preoperative CT and MR showed that lymphatic metastasis and distant metastasis could be positive.
6. Pregnant or lactating women.
7. Patients with severe mental disorders.
8. ASA score > 3.
9. Receive other cancer treatments (radiotherapy, chemotherapy).
10. Complication with other intestinal diseases (FAP, HNPCC, active ulcerative colitis or Crohn's disease).
11. The general situation is poor and there are other uncontrollable diseases.
12. Preoperative tumor stage was not T2N0M0.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: single transanal loca excision	Procedure: transanal local excision following radiotherapy; transanal local excision following radiotherapy
Experimental: transanal local excision following radiotherapy	Procedure: transanal local excision following radiotherapy; transanal local excision following radiotherapy
Experimental: total mesorectal excision	Procedure: transanal local excision following radiotherapy; transanal local excision following radiotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
5-years disease free survival rate	5 years

Secondary Outcome Measures

Outcome Measure	Time Frame
5-years overall survival rate	5 years
local recurrance rate	5 years
operative time	1 day
hospitalization time	15 days
postoperative quality of life as assessed by EORTC QLQ-C30 questionnaire	5 years

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital with Nanjing Medical University
• Investigators: Study Director: Yueming Sun, PhD, The First Affiliated Hospital with Nanjing Medical University

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2019
• Primary Completion (Anticipated): December 1, 2026
• Study Completion (Anticipated): December 1, 2026

Study Registration Dates

• First Submitted: September 19, 2019
• First Submitted That Met QC Criteria: September 20, 2019
• First Posted (Actual): September 23, 2019

Study Record Updates

• Last Update Posted (Actual): September 23, 2019
• Last Update Submitted That Met QC Criteria: September 20, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: transanal local excision; T2N0M0
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Rectal Neoplasms
• Other Study ID Numbers: CRSYM201909

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No