Lateral Lymph Node Dissection After Neoadjuvant Chemo-radiation in Advanced Low Rectal Cancer

NCT02614157 | Terminated DMC

• 1 other identifier: pLNR-201501
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

Lateral lymph nodes (LLD) metastasis is a major cause of local recurrence for advanced rectal cancer. As for the treatment strategies on LLN metastasis, there are huge controversies on whether lateral pelvic lymph nodes dissection (LLND) after neoadjuvant chemo-radiotherapy (nCRT) between Western and Eastern countries. Retrospective cohort evidences indicate that LLND following total mesorectal excision (TME) will bring benefit from cT3-4 rectal cancer, not regular predictive LLND, which will bring more side effects on the contrary. Existing reports tend to recommend LLND for specific individual with suspicious LLN metastasis. Moreover, there is a blank strict prospective randomized control study on the comparison of LLND+TME and LLND after nCRT. Therefore, our trial will compare the efficacy and safety of the two strategies for mid/low rectal cancer with suspicious LLN metastasis. The risk factors (such as radiologic factors, pathologic factors, and serum protein) to predict local recurrence and overall survival will be further investigated.

Conditions

Rectal Cancer

Keywords

rectal cancer; lateral lymph node dissection; neoadjuvant chemoradiation; total mesorectal excision; surgery; recurrence; metastasis; overall survival

Outcome Measures

Primary Outcomes (1)

• 3-year local recurrence

  until local-recurrence (up to 3 years)

Secondary Outcomes (4)

• overall survival

  3 years

• disease free survival

  3 years

• Incidence of sexual and urinary dysfunction

  1 year

• postoperative complications

  1 year

Study Arms (2)

LLND+TME group

EXPERIMENTAL

advanced rectal cancer patients after neoadjuvant chem-radiation with suspicious lateral lymph nodes involvement undergo lateral lymph node dissection and total mesorectal excision(LLND+TME)

Procedure: LLND; Device: labeled line

TME group

NO INTERVENTION

advanced rectal cancer patients after neoadjuvant chem-radiation with suspicious lateral lymph nodes involvement undergo total mesorectal excision (TME)solely, without LLND

Interventions

LLND PROCEDURE

advanced rectal cancer patients whose lymph nodes are suspiciously enlarged after neoadjuvant chemoradiation will undergo lateral lymph node dissection (LLND) and total mesorectal excision (TME)

Also known as: Lateral Lymph Node Dissection

LLND+TME group

labeled line DEVICE

LLND+TME group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed rectal cancer (below the peritoneal reflection) Clinical stage I, II, or III
• No extramesorectal lymph node swelling (shorter diameter is less than 10 mm)
• No invasion to other organ (s)
• PS: 0, 1
• No past history of chemotherapy, pelvic surgery or radiation
• Written informed consent operative criteria:
• Mesorectal excision is performed
• Operative findings:
• Main lesion of the tumor is located at the rectum
• Lower tumor margin is below the peritoneal reflection
• R0 after resection

You may not qualify if:

• High rectal cancer
• Multiple cancer patients
• Pregnant patients
• Psychological disorder
• Steroid administration
• Cardiac infarction within six months
• Severe pulmonary emphysema and pulmonary fibrosis

Sponsors & Collaborators

• West China Hospital: lead

Study Sites (1)

West China Hospital

Chengdu, Sichuan, 610000, China

Location

Related Publications (23)

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  PMID: 27884204 DERIVED

MeSH Terms

Conditions

Rectal Neoplasms; Recurrence; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplastic Processes

Study Officials

• Ziqiang Wang, MD,PhD

  West China Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 23, 2015
• First Posted: November 25, 2015
• Study Start: May 1, 2016
• Primary Completion: May 1, 2017
• Study Completion: May 1, 2017
• Last Updated: February 1, 2021

Record last verified: 2016-06

Locations

CN (1)