Chemoradiotherapy Sequenced Radical Surgery for Colorectal Cancer With PALNM
Concurrent Chemoradiotherapy Sequenced Radical Surgery for Para-aortic Lymph Node Metastasis of Left-sided Colon and Rectal Cancer
1 other identifier
interventional
40
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2022
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 28, 2021
CompletedFirst Posted
Study publicly available on registry
November 22, 2021
CompletedStudy Start
First participant enrolled
January 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2027
ExpectedNovember 22, 2021
October 1, 2021
2 years
October 28, 2021
November 18, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
DFS
From date of recruitment until the date of disease recurrece, assessed up to 5 years
LFFS
From date of recruitment until the date of para-aortic lymph node recurrence, assessed up to 3 years
Postoperative complications
From date of surgery until the date of 30 days after surgery
Study Arms (2)
radical surgery with PALND
EXPERIMENTALradical surgery without PALND
ACTIVE COMPARATORInterventions
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
surgery includes sufficient resection margins of the tumor and D3 dissection of the regional lymph nodes without PALND
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Qilu Hospital of Shandong University
Jinan, Shandong, 250012, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 28, 2021
First Posted
November 22, 2021
Study Start
January 1, 2022
Primary Completion
January 1, 2024
Study Completion (Estimated)
January 1, 2027
Last Updated
November 22, 2021
Record last verified: 2021-10