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Not yet recruiting NCT05129774

Chemoradiotherapy Sequenced Radical Surgery for Colorectal Cancer With PALNM

No phase Interventional Colorectal Neoplasms Malignant Lymph Node Excision Chemoradiotherapy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Radical surgery with PALND, Radical surgery without PALND.
Who it may be relevant to
Registry conditions: Colorectal Neoplasms Malignant, Lymph Node Excision, Chemoradiotherapy. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

Interventions

  • 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
  • Procedure Radical surgery without PALND
    surgery includes sufficient resection margins of the tumor and D3 dissection of the regional lymph nodes without PALND

Primary outcome measures

  • 5-year OS [Time frame: From date of recruitment until the date of death from any cause, assessed up to 5 years]
Secondary outcome measures (3)
  • DFS [Time frame: From date of recruitment until the date of disease recurrece, assessed up to 5 years]
  • LFFS [Time frame: From date of recruitment until the date of para-aortic lymph node recurrence, assessed up to 3 years]
  • Postoperative complications [Time frame: From date of surgery until the date of 30 days after surgery]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Sequential
Masking
Triple blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Qilu Hospital of Shandong University — Jinan

Identifiers

NCT: NCT05129774 · V123456

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗