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NCT05129774 | Not yet recruiting | Colorectal Neoplasms Malignant

Chemoradiotherapy Sequenced Radical Surgery for Colorectal Cancer With PALNM
Sponsor:

Q i road hospital o FS shake 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

Condition or disease

Colorectal Neoplasms Malignant

Lymph Node Excision

Chemoradiotherapy

Intervention/treatment

Radical surgery with PALND

Radical surgery without PALND

Phase

Not Applicable

Study Type : Interventional
Estimated Enrollment : 40 participants
Masking : Triple
Primary Purpose : Treatment
Official Title : Concurrent Chemoradiotherapy Sequenced Radical Surgery for Para-aortic Lymph Node Metastasis of Left-sided Colon and Rectal Cancer
Actual Study Start Date : January 1, 2022
Estimated Primary Completion Date : January 1, 2024
Estimated Study Completion Date : January 1, 2027
Arm Intervention/treatment

Experimental: radical surgery with PALND

Procedure: Radical surgery with PALND

Active Comparator: radical surgery without PALND

Procedure: Radical surgery without PALND
Ages Eligible for Study: 18 Years to 70 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
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
Chemoradiotherapy Sequenced Radical Surgery for Colorectal Cancer With PALNM

Location Details

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Chemoradiotherapy Sequenced Radical Surgery for Colorectal Cancer With PALNM

How to Participate

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Locations

Not yet recruiting

China, Shandong

Q i road hospital o FS shake university

women, Shandong, China, 250012