NCT03587480

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for not_applicable

Timeline
49mo left

Started Dec 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress65%
Dec 2018May 2030

First Submitted

Initial submission to the registry

June 28, 2018

Completed
18 days until next milestone

First Posted

Study publicly available on registry

July 16, 2018

Completed
5 months until next milestone

Study Start

First participant enrolled

December 17, 2018

Completed
6.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 24, 2025

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 24, 2030

Expected
Last Updated

November 25, 2022

Status Verified

March 1, 2022

Enrollment Period

6.4 years

First QC Date

June 28, 2018

Last Update Submit

November 22, 2022

Conditions

Rectal Neoplasm Malignant

Keywords

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

Outcome Measures

Primary Outcomes (1)

  • 3-year disease-free survival

    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 Outcomes (10)

  • Operative time

    Operation day

  • Blood loss

    Operation day

  • Incidence of sexual dysfunction

    3 years

  • Incidence of urinary dysfunction

    3 years

  • Incidence of defecation dysfunction

    3 years

  • +5 more secondary outcomes

Study Arms (2)

TME+LLND group

OTHER

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

Procedure: TME+LLND

TME+nCRT group

OTHER

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

Procedure: TME+nCRT

Interventions

TME+LLNDPROCEDURE

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

TME+LLND group
TME+nCRTPROCEDURE

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

TME+nCRT group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 -

You may not qualify if:

  • 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
  • Operative findings:
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Sixth Affiliate Hospital of Sun Yat-Sen University

Guangzhou, Guangdong, China

RECRUITING

Related Publications (9)

  • Ito M, Kobayashi A, Fujita S, Mizusawa J, Kanemitsu Y, Kinugasa Y, Komori K, Ohue M, Ota M, Akazai Y, Shiozawa M, Yamaguchi T, Akasu T, Moriya Y; Colorectal Cancer Study Group of Japan Clinical Oncology Group. Urinary dysfunction after rectal cancer surgery: Results from a randomized trial comparing mesorectal excision with and without lateral lymph node dissection for clinical stage II or III lower rectal cancer (Japan Clinical Oncology Group Study, JCOG0212). Eur J Surg Oncol. 2018 Apr;44(4):463-468. doi: 10.1016/j.ejso.2018.01.015. Epub 2018 Jan 17.

    PMID: 29428473BACKGROUND

  • Deng Y, Chi P, Lan P, Wang L, Chen W, Cui L, Chen D, Cao J, Wei H, Peng X, Huang Z, Cai G, Zhao R, Huang Z, Xu L, Zhou H, Wei Y, Zhang H, Zheng J, Huang Y, Zhou Z, Cai Y, Kang L, Huang M, Peng J, Ren D, Wang J. Modified FOLFOX6 With or Without Radiation Versus Fluorouracil and Leucovorin With Radiation in Neoadjuvant Treatment of Locally Advanced Rectal Cancer: Initial Results of the Chinese FOWARC Multicenter, Open-Label, Randomized Three-Arm Phase III Trial. J Clin Oncol. 2016 Sep 20;34(27):3300-7. doi: 10.1200/JCO.2016.66.6198. Epub 2016 Aug 1.

    PMID: 27480145BACKGROUND

  • Qin Q, Ma T, Deng Y, Zheng J, Zhou Z, Wang H, Wang L, Wang J. Impact of Preoperative Radiotherapy on Anastomotic Leakage and Stenosis After Rectal Cancer Resection: Post Hoc Analysis of a Randomized Controlled Trial. Dis Colon Rectum. 2016 Oct;59(10):934-42. doi: 10.1097/DCR.0000000000000665.

    PMID: 27602924BACKGROUND

  • Huang M, Lin J, Yu X, Chen S, Kang L, Deng Y, Zheng J, Luo Y, Wang L, Lan P, Wang J. Erectile and urinary function in men with rectal cancer treated by neoadjuvant chemoradiotherapy and neoadjuvant chemotherapy alone: a randomized trial report. Int J Colorectal Dis. 2016 Jul;31(7):1349-57. doi: 10.1007/s00384-016-2605-7. Epub 2016 Jun 6.

    PMID: 27270480BACKGROUND

  • Shinagawa T, Tanaka T, Nozawa H, Emoto S, Murono K, Kaneko M, Sasaki K, Otani K, Nishikawa T, Hata K, Kawai K, Watanabe T. Comparison of the guidelines for colorectal cancer in Japan, the USA and Europe. Ann Gastroenterol Surg. 2017 Dec 19;2(1):6-12. doi: 10.1002/ags3.12047. eCollection 2018 Jan.

    PMID: 29863118RESULT

  • Fujita S, Akasu T, Mizusawa J, Saito N, Kinugasa Y, Kanemitsu Y, Ohue M, Fujii S, Shiozawa M, Yamaguchi T, Moriya Y; Colorectal Cancer Study Group of Japan Clinical Oncology Group. Postoperative morbidity and mortality after mesorectal excision with and without lateral lymph node dissection for clinical stage II or stage III lower rectal cancer (JCOG0212): results from a multicentre, randomised controlled, non-inferiority trial. Lancet Oncol. 2012 Jun;13(6):616-21. doi: 10.1016/S1470-2045(12)70158-4. Epub 2012 May 15.

    PMID: 22591948RESULT

  • Fujita S, Mizusawa J, Kanemitsu Y, Ito M, Kinugasa Y, Komori K, Ohue M, Ota M, Akazai Y, Shiozawa M, Yamaguchi T, Bandou H, Katsumata K, Murata K, Akagi Y, Takiguchi N, Saida Y, Nakamura K, Fukuda H, Akasu T, Moriya Y; Colorectal Cancer Study Group of Japan Clinical Oncology Group. Mesorectal Excision With or Without Lateral Lymph Node Dissection for Clinical Stage II/III Lower Rectal Cancer (JCOG0212): A Multicenter, Randomized Controlled, Noninferiority Trial. Ann Surg. 2017 Aug;266(2):201-207. doi: 10.1097/SLA.0000000000002212.

    PMID: 28288057RESULT

  • Nagawa H, Muto T, Sunouchi K, Higuchi Y, Tsurita G, Watanabe T, Sawada T. Randomized, controlled trial of lateral node dissection vs. nerve-preserving resection in patients with rectal cancer after preoperative radiotherapy. Dis Colon Rectum. 2001 Sep;44(9):1274-80. doi: 10.1007/BF02234784.

    PMID: 11584199RESULT

  • Ogura A, Akiyoshi T, Nagasaki T, Konishi T, Fujimoto Y, Nagayama S, Fukunaga Y, Ueno M, Kuroyanagi H. Feasibility of Laparoscopic Total Mesorectal Excision with Extended Lateral Pelvic Lymph Node Dissection for Advanced Lower Rectal Cancer after Preoperative Chemoradiotherapy. World J Surg. 2017 Mar;41(3):868-875. doi: 10.1007/s00268-016-3762-0.

    PMID: 27730352RESULT

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Yanxin Luo

    Sixth Affiliated Hospital, Sun Yat-sen University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yanxin Luo

CONTACT

020-38250745luoyx25@mail.sysu.edu.cn

Shaoyong Peng

CONTACT

86-13435613566pengshy9@mail2.sysu.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 28, 2018

First Posted

July 16, 2018

Study Start

December 17, 2018

Primary Completion

May 24, 2025

Study Completion (Estimated)

May 24, 2030

Last Updated

November 25, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)