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NCT Number: NCT03587480

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

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

Recruiting

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TME+LLND

Procedure

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

TME+nCRT

Procedure

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

Primary outcomes

  1. 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

Secondary outcomes

  1. Operative time

    Time frame: Operation day

    Operation day

  2. Blood loss

    Time frame: Operation day

    in the perioperative period

  3. Incidence of sexual dysfunction

    Time frame: 3 years

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

  4. Incidence of urinary dysfunction

    Time frame: 3 years

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

  5. Incidence of defecation dysfunction

    Time frame: 3 years

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

  6. incidence of Postoperative complications

    Time frame: 3 months

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

  7. overall survival

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

    60 months after surgery

  8. 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

  9. 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

  10. the score of quality of life

    Time frame: 3 months after operation

    The study investigate the quality of life using the WHOQOL Scale

Study contacts

Contact information is provided by the study sponsor or research team.

Shaoyong Peng

CONTACT

[email protected]

86-13435613566

Yanxin Luo

CONTACT

[email protected]

020-38250745

Sponsors and collaborators

Lead sponsor

Sixth Affiliated Hospital, Sun Yat-sen University

Other

Registry information

Official study 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

Acronym: TELEPHOME

Important dates

Study start
2018
Primary completion
2025
Study completion
2030
First posted
Jul 16, 2018
Registry last updated
Nov 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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