Chemoradiotherapy Sequenced Radical Surgery for Colorectal Cancer With PALNM

Study Overview
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Brief Summary
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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

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

Conditions
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Colorectal Neoplasms Malignant, Lymph Node Excision, Chemoradiotherapy

Intervention / Treatment
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* Procedure: Radical surgery with PALND
* Procedure: Radical surgery without PALND


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: radical surgery with PALND<br> | Procedure: Radical surgery with PALND<br>* 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<br>|
| Active Comparator: radical surgery without PALND<br> | Procedure: Radical surgery without PALND<br>* surgery includes sufficient resection margins of the tumor and D3 dissection of the regional lymph nodes without PALND<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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