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

Not Applicable

Recruiting

• Conditions: Rectal Neoplasm Malignant
• Interventions: Procedure: TME+LLND; Procedure: TME+nCRT

• Registration Number: NCT03587480
• Lead Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University

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

Study Timeline

• Study First Submitted: 2018-06-28
• Study First Submitted QC: 2018-07-13
• Study First Posted: 2018-07-16
• Study Start: 2018-12-17
• Status Verified: 2022-03
• Last Update Submitted: 2022-11-22
• Last Update Posted: 2022-11-25
• Primary Completion: 2025-05-24
• Study Completion: 2030-05-24

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 250

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TME+LLND group	TME+LLND	Total Mesorectal Excision plus Lateral Lymph Node Dissection for low rectal cancer with regional lymph node metastasis.
TME+nCRT group	TME+nCRT	Total Mesorectal Excision After Neoadjuvant Chemo-radiotherapy for low rectal cancer with regional lymph node metastasis.

Primary Outcome Measures

Name	Time	Method
3-year disease-free survival	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 Outcome Measures

Name	Time	Method
incidence of Postoperative complications	3 months	From the date of operation until the date of complication,assessed up to 3 months
5-year disease-free survival	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
Incidence of defecation dysfunction	3 years	From the date of operation until the date of complication,assessed up to 3 years
overall survival	From the date of operation until the date of death,assessed up to 5 years	60 months after surgery
Operative time	Operation day	Operation day
Blood loss	Operation day	in the perioperative period
Incidence of sexual dysfunction	3 years	From the date of operation until the date of complication,assessed up to 3 years
Incidence of urinary dysfunction	3 years	From the date of operation until the date of complication,assessed up to 3 years
3-year local recurrence rate	From date of operation until the date of local-recurrence (up to 3 years)	36 months after surgery
the score of quality of life	3 months after operation	The study investigate the quality of life using the WHOQOL Scale

Trial Locations

Locations (1)

The Sixth Affiliate Hospital of Sun Yat-Sen University; 🇨🇳 GuangZhou, Guangdong, China