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

Primary Purpose

Rectal Neoplasm Malignant

Status

Recruiting

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

TME+LLND

TME+nCRT

About this trial

This is an interventional treatment trial for Rectal Neoplasm Malignant focused on measuring Low rectal cancer, Total Mesorectal Excision (TME), neoadjuvant Chemo-radiotherapy (nCRT), lateral lymph node dissection (LLND)

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Histologically confirmed adenocarcinoma(below the peritoneal reflection) Clinical stage Ⅲ
Tumor is capable of performing radical recession
No past history of chemotherapy, pelvic radiation of other cancers.
Written informed consent
Lower tumor margin is confirmed below the peritoneal reflection
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:

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

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

Sites / Locations

The Sixth Affiliate Hospital of Sun Yat-Sen UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Arm Label

TME+LLND group

TME+nCRT group

Arm Description

Total Mesorectal Excision plus Lateral Lymph Node Dissection for low rectal cancer with regional lymph node metastasis.

Total Mesorectal Excision After Neoadjuvant Chemo-radiotherapy for low rectal cancer with regional lymph node metastasis.

Outcomes

Primary Outcome Measures

3-year disease-free survival

36 months after surgery

Secondary Outcome Measures

Operative time

Operation day

Blood loss

in the perioperative period

Incidence of sexual dysfunction

From the date of operation until the date of complication,assessed up to 3 years

Incidence of urinary dysfunction

From the date of operation until the date of complication,assessed up to 3 years

Incidence of defecation dysfunction

From the date of operation until the date of complication,assessed up to 3 years

incidence of Postoperative complications

From the date of operation until the date of complication,assessed up to 3 months

overall survival

60 months after surgery

3-year local recurrence rate

36 months after surgery

5-year disease-free survival

60 months after surgery

the score of quality of life

The study investigate the quality of life using the WHOQOL Scale

Full Information

NCT ID

NCT03587480

First Posted

June 28, 2018

Last Updated

November 22, 2022

Sponsor

Sixth Affiliated Hospital, Sun Yat-sen University

1. Study Identification

Unique Protocol Identification Number

NCT03587480

Brief Title

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

Acronym

TELEPHOME

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Recruiting

Study Start Date

December 17, 2018 (Actual)

Primary Completion Date

May 24, 2025 (Anticipated)

Study Completion Date

May 24, 2030 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sixth Affiliated Hospital, Sun Yat-sen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rectal Neoplasm Malignant

Keywords

Low rectal cancer, Total Mesorectal Excision (TME), neoadjuvant Chemo-radiotherapy (nCRT), lateral lymph node dissection (LLND)

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

TME+LLND group

Arm Type

Other

Arm Description

Total Mesorectal Excision plus Lateral Lymph Node Dissection for low rectal cancer with regional lymph node metastasis.

Arm Title

TME+nCRT group

Arm Type

Other

Arm Description

Total Mesorectal Excision After Neoadjuvant Chemo-radiotherapy for low rectal cancer with regional lymph node metastasis.

Intervention Type

Procedure

Intervention Name(s)

TME+LLND

Intervention Description

patients in TME+LLND group receive Lateral Lymph Node Dissection (LLND) after Total Mesorectal Excision(TME)

Intervention Type

Procedure

Intervention Name(s)

TME+nCRT

Intervention Description

patients in TME+nCRT group receive Neoadjuvant Chemo-radiotherapy (nCRT) before Total Mesorectal Excision(TME)

Primary Outcome Measure Information:

Title

3-year disease-free survival

Description

36 months after surgery

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

Secondary Outcome Measure Information:

Title

Operative time

Description

Operation day

Time Frame

Operation day

Title

Blood loss

Description

in the perioperative period

Time Frame

Operation day

Title

Incidence of sexual dysfunction

Description

From the date of operation until the date of complication,assessed up to 3 years

Time Frame

3 years

Title

Incidence of urinary dysfunction

Description

From the date of operation until the date of complication,assessed up to 3 years

Time Frame

3 years

Title

Incidence of defecation dysfunction

Description

From the date of operation until the date of complication,assessed up to 3 years

Time Frame

3 years

Title

incidence of Postoperative complications

Description

From the date of operation until the date of complication,assessed up to 3 months

Time Frame

3 months

Title

overall survival

Description

60 months after surgery

Time Frame

From the date of operation until the date of death,assessed up to 5 years

Title

3-year local recurrence rate

Description

36 months after surgery

Time Frame

From date of operation until the date of local-recurrence (up to 3 years)

Title

5-year disease-free survival

Description

60 months after surgery

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

Title

the score of quality of life

Description

The study investigate the quality of life using the WHOQOL Scale

Time Frame

3 months after operation

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Histologically confirmed adenocarcinoma(below the peritoneal reflection) Clinical stage Ⅲ Tumor is capable of performing radical recession No past history of chemotherapy, pelvic radiation of other cancers. Written informed consent Lower tumor margin is confirmed below the peritoneal reflection 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: Past history of other cancers Multiple Primary Colorectal Cancers or Familial adenomatous polyposis(FAP) Combine with inflammatory bowl disease(IBD) Recurrence tumor or invade other organs Combine with obstruction,perforation or bleeding which need emergency surgery. Local tumor invade the external sphincter, levator ani muscle or adjacent organs Participant join other clinical trials in 4 weeks. American Society of Anesthesiologists(ASA) ≥Ⅳ and/or Eastern Cooperative Oncology Group(ECOG) ≤2 Pregnant or lactating patients Severity infection before operation Psychological disorder Severe dysfunction of organs or other contraindications Cardiac infarction within six months Severe pulmonary emphysema and pulmonary fibrosis Doctor's decision for exclusion Operative findings: Tumor invade other organs Lower tumor margin is above the peritoneal reflection

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Yanxin Luo

Phone

020-38250745

luoyx25@mail.sysu.edu.cn

First Name & Middle Initial & Last Name or Official Title & Degree

Shaoyong Peng

Phone

86-13435613566

pengshy9@mail2.sysu.edu.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yanxin Luo

Organizational Affiliation

Sixth Affiliated Hospital, Sun Yat-sen University

Official's Role

Principal Investigator

Facility Information:

Facility Name

The Sixth Affiliate Hospital of Sun Yat-Sen University

City

GuangZhou

State/Province

Guangdong

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yanxin Luo, PhD,MD

Phone

86-13826190263

luoyx25@mail.sysu.edu.cn

First Name & Middle Initial & Last Name & Degree

Shaoyong Peng, MD

Phone

86-13435613566

pengshy9@mail2.sysu.edu.cn

12. IPD Sharing Statement

Plan to Share IPD

Citations:

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

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