Chemoradiotherapy Sequenced Radical Surgery for Colorectal Cancer With PALNM

NCT05129774 · tracked via the Priya Life Science China tracker

Sponsor

Qilu Hospital of Shandong University

Phase

Not applicable

Started

2022-01-01

Last updated

2021-11-22

Condition(s) studied

Colorectal Neoplasms MalignantLymph Node ExcisionChemoradiotherapy

Investigational drug(s) / intervention(s)

Radical surgery with PALNDRadical surgery without PALND

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

Study 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

Eligibility

Sex

ALL

Min age

18 Years

Max age

70 Years

Healthy volunteers

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

Primary outcome measure(s)

5-year OS — From date of recruitment until the date of death from any cause, assessed up to 5 years
5-year overall survival

Trial sites (1)

Facility	City	Region	Status
Qilu Hospital of Shandong University	Jinan	Shandong

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05129774 on ClinicalTrials.gov ↗ ← All trials in China