Concurrent Chemoradiotherapy Sequenced Radical Surgery for Para-aortic Lymph Node Metastasis of Left-sided Colon and Rectal Cancer

Qilu Hospital of Shandong University1 site in 1 country40 target enrollmentJanuary 1, 2022

ConditionsColorectal Neoplasms Malignant Lymph Node Excision Chemoradiotherapy

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Colorectal Neoplasms Malignant
Sponsor: Qilu Hospital of Shandong University
Enrollment: 40
Locations: 1
Primary Endpoint: 5-year OS
Status: Not yet recruiting
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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

Registry

clinicaltrials.gov

Start Date

January 1, 2022

End Date

January 1, 2027

Last Updated

4 years ago

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

Qilu Hospital of Shandong University

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

5-year OS

Time Frame: From date of recruitment until the date of death from any cause, assessed up to 5 years

5-year overall survival

Secondary Outcomes

Postoperative complications(From date of surgery until the date of 30 days after surgery)
LFFS(From date of recruitment until the date of para-aortic lymph node recurrence, assessed up to 3 years)
DFS(From date of recruitment until the date of disease recurrece, assessed up to 5 years)