Chemoradiotherapy Sequenced Radical Surgery for Colorectal Cancer With PALNM
Primary Purpose
Colorectal Neoplasms Malignant, Lymph Node Excision, Chemoradiotherapy
Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Radical surgery with PALND
Radical surgery without PALND
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Neoplasms Malignant
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
Sites / Locations
- Qilu Hospital of Shandong University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
radical surgery with PALND
radical surgery without PALND
Arm Description
Outcomes
Primary Outcome Measures
5-year OS
5-year overall survival
Secondary Outcome Measures
DFS
5-year disease-free survival
LFFS
Local failure free survival
Postoperative complications
Postoperative complications
Full Information
NCT ID
NCT05129774
First Posted
October 28, 2021
Last Updated
November 18, 2021
Sponsor
Qilu Hospital of Shandong University
1. Study Identification
Unique Protocol Identification Number
NCT05129774
Brief Title
Chemoradiotherapy Sequenced Radical Surgery for Colorectal Cancer With PALNM
Official Title
Concurrent Chemoradiotherapy Sequenced Radical Surgery for Para-aortic Lymph Node Metastasis of Left-sided Colon and Rectal Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 1, 2022 (Anticipated)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
January 1, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Qilu Hospital of Shandong University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Neoplasms Malignant, Lymph Node Excision, Chemoradiotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
radical surgery with PALND
Arm Type
Experimental
Arm Title
radical surgery without PALND
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Radical surgery with PALND
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Radical surgery without PALND
Intervention Description
surgery includes sufficient resection margins of the tumor and D3 dissection of the regional lymph nodes without PALND
Primary Outcome Measure Information:
Title
5-year OS
Description
5-year overall survival
Time Frame
From date of recruitment until the date of death from any cause, assessed up to 5 years
Secondary Outcome Measure Information:
Title
DFS
Description
5-year disease-free survival
Time Frame
From date of recruitment until the date of disease recurrece, assessed up to 5 years
Title
LFFS
Description
Local failure free survival
Time Frame
From date of recruitment until the date of para-aortic lymph node recurrence, assessed up to 3 years
Title
Postoperative complications
Description
Postoperative complications
Time Frame
From date of surgery until the date of 30 days after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yong Dai, M.D. Ph.D.
Phone
+8618560085117
Email
yongdai@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Xiang Zhang, M.D. Ph.D.
Phone
+8618560089182
Email
xiang.zhang02@hotmail.com
Facility Information:
Facility Name
Qilu Hospital of Shandong University
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250012
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiang Zhang
Phone
18560089182
Email
xiang.zhang02@hotmail.com
First Name & Middle Initial & Last Name & Degree
Yanlei Wang
Phone
18560085128
Email
yanleiwang@hotmail.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Chemoradiotherapy Sequenced Radical Surgery for Colorectal Cancer With PALNM
We'll reach out to this number within 24 hrs