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Rectal Neoplasm MalignantTELEPHOMENCT03587480

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

A study testing TME+LLND and TME+nCRT in people with Rectal Neoplasm Malignant, run by Sixth Affiliated Hospital, Sun Yat-sen University at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Rectal Neoplasm Malignant
What is being tested?
TME+LLND and TME+nCRT
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
250 participants
Where
1 siteChina
Study dates
17 Dec 2018to 24 May 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

  • 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 -

Who cannot join

  • 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
Show all 17Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Yanxin Luo contact

020-38250745

luoyx25@mail.sysu.edu.cn

Shaoyong Peng contact

86-13435613566

pengshy9@mail2.sysu.edu.cn

China1 site, 1 recruiting

  • The Sixth Affiliate Hospital of Sun Yat-Sen University

    Guangzhou, Guangdong

    Yanxin Luo, PhD,MD, 86-13826190263, luoyx25@mail.sysu.edu.cn

    Shaoyong Peng, MD, 86-13435613566, pengshy9@mail2.sysu.edu.cn

    Recruiting

Other trials in China

About this study

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

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

Read the 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

Being tested
TME+LLND, TME+nCRT
Keywords
Low rectal cancer, Total Mesorectal Excision (TME), neoadjuvant Chemo-radiotherapy (nCRT), lateral lymph node dissection (LLND)
Medical subject headings
Rectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TME+LLNDProcedure or surgery

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

  • TME+nCRTProcedure or surgery

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

Study groups in NCT03587480
Study groupRoleWhat they receive
TME+LLND groupOtherTotal Mesorectal Excision plus Lateral Lymph Node Dissection for low rectal cancer with regional lymph node metastasis.
Receives: Procedure: TME+LLND
TME+nCRT groupOtherTotal Mesorectal Excision After Neoadjuvant Chemo-radiotherapy for low rectal cancer with regional lymph node metastasis.
Receives: Procedure: TME+nCRT

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 3-year disease-free survival

    36 months after surgery

    Measured: 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)

  1. Operative time

    Operation day

    Measured: Operation day

  2. Blood loss

    in the perioperative period

    Measured: Operation day

  3. Incidence of sexual dysfunction

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

    Measured: 3 years

  4. Incidence of urinary dysfunction

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

    Measured: 3 years

  5. Incidence of defecation dysfunction

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

    Measured: 3 years

  6. incidence of Postoperative complications

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

    Measured: 3 months

  7. overall survival

    60 months after surgery

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

  8. 3-year local recurrence rate

    36 months after surgery

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

  9. 5-year disease-free survival

    60 months after surgery

    Measured: 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

  10. the score of quality of life

    The study investigate the quality of life using the WHOQOL Scale

    Measured: 3 months after operation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jul 2018
  2. Study start17 Dec 2018
  3. Primary completion24 May 2025 (estimated)
  4. Study completion24 May 2030 (estimated)

Resources

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
None (open label)
Enrolment
250 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03587480
Sponsor's protocol ID
Luo-20180624
Acronym
TELEPHOME
Status last verified
Mar 2022
First submitted
28 Jun 2018
Last updated
25 Nov 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 29428473

  • 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.

    PubMed 27480145

  • 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.

    PubMed 27602924

  • 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.

    PubMed 27270480

  • 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.

    PubMed 29863118

  • 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.

    PubMed 22591948

  • 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.

    PubMed 28288057

  • 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.

    PubMed 11584199

  • 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.

    PubMed 27730352

Questions about this trial

What is this clinical trial studying?

A study testing TME+LLND and TME+nCRT in people with Rectal Neoplasm Malignant, run by Sixth Affiliated Hospital, Sun Yat-sen 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 6 inclusion and 17 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 25 Nov 2022. 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 Yanxin Luo (020-38250745, luoyx25@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). 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 NCT03587480, which also lists 9 linked publications.

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 25 Nov 2022.

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