Chemoradiotherapy Sequenced Radical Surgery for Colorectal Cancer With PALNM

Not Applicable

Not yet recruiting

• Conditions: Lymph Node Excision; Colorectal Neoplasms Malignant; Chemoradiotherapy
• Interventions: Procedure: Radical surgery with PALND; Procedure: Radical surgery without PALND

• Registration Number: NCT05129774
• Lead Sponsor: Qilu Hospital of Shandong University

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-10
• Study First Submitted: 2021-10-28
• Study First Submitted QC: 2021-11-18
• Last Update Submitted: 2021-11-18
• Study First Posted: 2021-11-22
• Last Update Posted: 2021-11-22
• Study Start: 2022-01-01
• Primary Completion: 2024-01-01
• Study Completion: 2027-01-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

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

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
radical surgery with PALND	Radical surgery with PALND	-
radical surgery without PALND	Radical surgery without PALND	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Postoperative complications	From date of surgery until the date of 30 days after surgery	Postoperative complications
LFFS	From date of recruitment until the date of para-aortic lymph node recurrence, assessed up to 3 years	Local failure free survival
DFS	From date of recruitment until the date of disease recurrece, assessed up to 5 years	5-year disease-free survival

Trial Locations

Locations (1)

Qilu Hospital of Shandong University; 🇨🇳 Jinan, Shandong, China