Total Mesorectal Excision(TME) With Lateral Lymph Node Dissection Versus TME After Neoadjuvant Chemo-radiotherapy (TELEPHOME)

November 22, 2022 updated by: Sixth Affiliated Hospital, Sun Yat-sen University

Total Mesorectal Excision(TME) With Lateral Lymph Node Dissection Versus TME After Neoadjuvant Chemo-radiotherapy of Lower Rectal Cancer With Suspected Local Lymph Node Metastasis

Treatment for Low rectal cancer, especially in patients with regional lymph node metastasis are quite different between Japanese guideline (JSCCR) and western countries' guideline (NCCN, ESMO). While Japanese scholars advocate total mesorectal excision (TME) plus lateral lymph node dissection (LLND), European and American scholars advocate TME alone after Neoadjuvant Chemo-radiotherapy (nCRT), without the need of LLND. Accordingly, this clinical trial is designed to directly compare the efficacy and safety of these two treatment strategies for low rectal cancer with regional lymph node metastasis. It will provide high-level clinical evidence for the treatment of low rectal cancer with suspected local lymph node metastasis

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

There are significant differences between Japanese guidelines (JSCCR) and Western guidelines (NCCN, ESMO) in the treatment of low rectal cancer, especially in patients with regional lymph node metastasis. Japanese scholars advocated total meso rectal resection (TME) + Lateral lymph node dissection (LLND), However, European and American scholars advocate that only TME is used after new adjuvant chemo-radiation (nCRT), without LLND. Therefore, the purpose of this clinical trial was to directly compare the efficacy and safety of these two treatment strategies for low rectal cancer with regional lymph node metastasis. This will provide a high level of clinical evidence for the treatment of low rectal cancer with suspected local lymph node metastasis

Study Type

Interventional

Enrollment (Anticipated)

250

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Guangdong
      • GuangZhou, Guangdong, China
        • Recruiting
        • The Sixth Affiliate Hospital of Sun Yat-Sen University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Histologically confirmed adenocarcinoma(below the peritoneal reflection) Clinical stage Ⅲ
  2. Tumor is capable of performing radical recession
  3. No past history of chemotherapy, pelvic radiation of other cancers.
  4. Written informed consent
  5. Lower tumor margin is confirmed below the peritoneal reflection
  6. Clinical state T(1-3)N(1-2)M0 is confirmed by the multiple disciplines team(MDT) including surgeons,diagnostic radiologist,radiation oncologist and medical oncologists base on MRI and endorectal ultrasound -

Exclusion Criteria:

  1. Past history of other cancers
  2. Multiple Primary Colorectal Cancers or Familial adenomatous polyposis(FAP)
  3. Combine with inflammatory bowl disease(IBD)
  4. Recurrence tumor or invade other organs
  5. Combine with obstruction,perforation or bleeding which need emergency surgery.
  6. Local tumor invade the external sphincter, levator ani muscle or adjacent organs
  7. Participant join other clinical trials in 4 weeks.
  8. American Society of Anesthesiologists(ASA) ≥Ⅳ and/or Eastern Cooperative Oncology Group(ECOG) ≤2
  9. Pregnant or lactating patients
  10. Severity infection before operation
  11. Psychological disorder
  12. Severe dysfunction of organs or other contraindications
  13. Cardiac infarction within six months
  14. Severe pulmonary emphysema and pulmonary fibrosis
  15. Doctor's decision for exclusion
  16. Operative findings:

Tumor invade other organs Lower tumor margin is above the peritoneal reflection

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: TME+LLND group
Total Mesorectal Excision plus Lateral Lymph Node Dissection for low rectal cancer with regional lymph node metastasis.
Procedure: TME+LLND
patients in TME+LLND group receive Lateral Lymph Node Dissection (LLND) after Total Mesorectal Excision(TME)
Other: TME+nCRT group
Total Mesorectal Excision After Neoadjuvant Chemo-radiotherapy for low rectal cancer with regional lymph node metastasis.
Procedure: TME+nCRT
patients in TME+nCRT group receive Neoadjuvant Chemo-radiotherapy (nCRT) before Total Mesorectal Excision(TME)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
3-year disease-free survival
Time Frame: From date of operation until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years
36 months after surgery
From date of operation until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Operative time
Time Frame: Operation day
Operation day
Operation day
Blood loss
Time Frame: Operation day
in the perioperative period
Operation day
Incidence of sexual dysfunction
Time Frame: 3 years
From the date of operation until the date of complication,assessed up to 3 years
3 years
Incidence of urinary dysfunction
Time Frame: 3 years
From the date of operation until the date of complication,assessed up to 3 years
3 years
Incidence of defecation dysfunction
Time Frame: 3 years
From the date of operation until the date of complication,assessed up to 3 years
3 years
incidence of Postoperative complications
Time Frame: 3 months
From the date of operation until the date of complication,assessed up to 3 months
3 months
overall survival
Time Frame: From the date of operation until the date of death,assessed up to 5 years
60 months after surgery
From the date of operation until the date of death,assessed up to 5 years
3-year local recurrence rate
Time Frame: From date of operation until the date of local-recurrence (up to 3 years)
36 months after surgery
From date of operation until the date of local-recurrence (up to 3 years)
5-year disease-free survival
Time Frame: From date of operation until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years
60 months after surgery
From date of operation until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years
the score of quality of life
Time Frame: 3 months after operation
The study investigate the quality of life using the WHOQOL Scale
3 months after operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sixth Affiliated Hospital, Sun Yat-sen University

Investigators

  • Principal Investigator: Yanxin Luo, Sixth Affiliated Hospital, Sun Yat-sen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 17, 2018

Primary Completion (Anticipated)

May 24, 2025

Study Completion (Anticipated)

May 24, 2030

Study Registration Dates

First Submitted

June 28, 2018

First Submitted That Met QC Criteria

July 13, 2018

First Posted (Actual)

July 16, 2018

Study Record Updates

Last Update Posted (Actual)

November 25, 2022

Last Update Submitted That Met QC Criteria

November 22, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Luo-20180624

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Rectal Neoplasm Malignant

Clinical Trials on TME+LLND

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Slovakia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe