Chemoradiotherapy Sequenced Radical Surgery for Colorectal Cancer With PALNM

November 18, 2021 updated by: Qilu Hospital of Shandong University

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: SEQUENTIAL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: radical surgery with PALND
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
Active Comparator: radical surgery without PALND
Procedure: Radical surgery without PALND
surgery includes sufficient resection margins of the tumor and D3 dissection of the regional lymph nodes without PALND

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From date of recruitment until the date of death from any cause, assessed up to 5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
DFS
Time Frame: From date of recruitment until the date of disease recurrece, assessed up to 5 years
5-year disease-free survival
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
Local failure free survival
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
Postoperative complications
From date of surgery until the date of 30 days after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Qilu Hospital of Shandong University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 1, 2022

Primary Completion (Anticipated)

January 1, 2024

Study Completion (Anticipated)

January 1, 2027

Study Registration Dates

First Submitted

October 28, 2021

First Submitted That Met QC Criteria

November 18, 2021

First Posted (Actual)

November 22, 2021

Study Record Updates

Last Update Posted (Actual)

November 22, 2021

Last Update Submitted That Met QC Criteria

November 18, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • V123456

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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