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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05129774
Other study ID # V123456
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date January 1, 2022
Est. completion date January 1, 2027

Study information

Verified date October 2021
Source Qilu Hospital of Shandong University
Contact Yong Dai, M.D. Ph.D.
Phone +8618560085117
Email yongdai@hotmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

In left-sided colon and rectal cancer, the occurrence of synchronous para-aortic lymph node metastasis is rare, with the incidence of being approximate 1-2%. Currently, there has been no standard treatment strategy for this situation. The present trial is designed to evaluate the safety and efficacy of para-aortic lymph node dissection for left-sided colon and rectal cancer with synchronous para-aortic lymph node metastasis


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 40
Est. completion date January 1, 2027
Est. primary completion date January 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria: - age at enrollment is = 18 and = 75 years - ECOG PS 0-1 - histologically confirmed left-sided colon and rectal carcinoma - synchronous para-aortic lymph node metastases confirmed by PET-CT, and located below the level of renal veins and above the bifurcation of iliac artery - patients potential to receive surgery and achieve no evidence of disease (NED) - able to tolerate surgery - providing written informed consent Exclusion Criteria: - local invasion or distant metastasis other than para-aoritc lymph nodes - history of other malignant tumor - coupled with severe systematic diseases (recent myocardial infarction, cardiomyopathy, or acute pulmonary infection) - emergency surgery

Study Design


Intervention

Procedure:
Radical surgery with PALND
sufficient resection margins of the tumor, D3 dissection of the regional lymph nodes and para-aortic lymph node dissection from the bifurcation of iliac artery to the left renal vein via laparoscopic approach
Radical surgery without PALND
surgery includes sufficient resection margins of the tumor and D3 dissection of the regional lymph nodes without PALND

Locations

Country Name City State
China Qilu Hospital of Shandong University Jinan Shandong

Sponsors (1)

Lead Sponsor Collaborator
Qilu Hospital of Shandong University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 5-year OS 5-year overall survival From date of recruitment until the date of death from any cause, assessed up to 5 years
Secondary DFS 5-year disease-free survival From date of recruitment until the date of disease recurrece, assessed up to 5 years
Secondary LFFS Local failure free survival From date of recruitment until the date of para-aortic lymph node recurrence, assessed up to 3 years
Secondary Postoperative complications Postoperative complications From date of surgery until the date of 30 days after surgery
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