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NCT Number: NCT05129774

Chemoradiotherapy Sequenced Radical Surgery for Colorectal Cancer With PALNM

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

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Key information

Conditions

Colorectal Neoplasms Malignant Chemoradiotherapy Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Lymph Node Excision Neoplasms Neoplasms by Site

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Radical surgery with PALND

Procedure

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

Procedure

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

Primary outcomes

  1. 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

  1. DFS

    Time frame: From date of recruitment until the date of disease recurrece, assessed up to 5 years

    5-year disease-free survival

  2. LFFS

    Time frame: From date of recruitment until the date of para-aortic lymph node recurrence, assessed up to 3 years

    Local failure free survival

  3. Postoperative complications

    Time frame: From date of surgery until the date of 30 days after surgery

    Postoperative complications

Study contacts

Contact information is provided by the study sponsor or research team.

Xiang Zhang, M.D. Ph.D.

CONTACT

[email protected]

+8618560089182

Yong Dai, M.D. Ph.D.

CONTACT

[email protected]

+8618560085117

Sponsors and collaborators

Lead sponsor

Qilu Hospital of Shandong University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2027
First posted
Nov 22, 2021
Registry last updated
Nov 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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