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Systemic Therapy Sequenced Isolated PALND for mCRC

Primary Purpose

Synchronous Isolated Para-aortic Lymph Node Metastasis, Colorectal Cancer

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Para-aortic lymph node dissection
Sponsored by
First Affiliated Hospital of Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Synchronous Isolated Para-aortic Lymph Node Metastasis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age at enrollment is >= 18 and <= 75 years
  2. ECOG PS 0-1
  3. Histologically confirmed colorectal carcinoma
  4. Synchronous metastatic colorectal cancer with isolated para-aortic lymph node metastases: In the preoperative examination of positron emission tomography CT and abdominopelvic CT, metastasis was noted when the diameter of the PALN was 10 mm or greater and had irregular shape.
  5. Single-organ para-aortic lymph node metastasis (PLANM) who are potential to receive surgery and achieve no evidence of disease (NED).
  6. Adequate liver, renal and bona marrow function.
  7. Signing written informed consent

Exclusion Criteria:

  1. In addition to PALN metastasis, distant metastases such as lung, liver, peritoneum and bone were presen and in instances when the renal vein was in the upward spread path of the LN metastasis.
  2. Unable to achieve NED
  3. Clinically severe (ie, active) heart disease, such as symptomatic coronary heart disease, New York Heart Association (NYHA) class II or more severe congestive heart failure or severe arrhythmia requiring medication intervention, Or a history of myocardial infarction in the last 12 months.
  4. Those with other history of malignant disease in the last 5 years, except for cured skin cancer and cervical carcinoma in situ.
  5. Organ transplantation requires immunosuppressive therapy

Sites / Locations

  • The First Affiliated Hospital, Zhejiang University School of MedicineRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Systemic therapy sequenced PALND

Arm Description

All received systemtic therapy (at most two lines).

Outcomes

Primary Outcome Measures

3-year DFS
Time with no recurrence of the diseases.

Secondary Outcome Measures

5-year OS
From date of recruitment until the date of death from any cause, assessed up to 5 years.
LFS
Time with no recurrence of the paraaortic lymph node region.
1-year DFS
Time with no recurrence of the diseases.

Full Information

First Posted
February 25, 2021
Last Updated
October 4, 2021
Sponsor
First Affiliated Hospital of Zhejiang University
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1. Study Identification

Unique Protocol Identification Number
NCT04774757
Brief Title
Systemic Therapy Sequenced Isolated PALND for mCRC
Official Title
Curative Systemic Therapy Sequenced Radical Surgery for Synchronous Isolated Paraaortic Lymph Node Metastasis of Colorectal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Recruiting
Study Start Date
March 10, 2021 (Actual)
Primary Completion Date
March 1, 2023 (Anticipated)
Study Completion Date
March 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
First Affiliated Hospital of Zhejiang University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The study aims to estimate the efficacy and safety of systemic therapy sequenced radical surgery in treating patients with synchronous isolated para-aortic lymph node metastasis of colorectal cancer.
Detailed Description
Patients with synchrnous isolated para-aortic lymph node metastasis of colorectal cancer receiving systemtic therapy (at most two lines), radiologically assessed efficacious, and assessed by MDT that are potential to reach no evidence of disease (NED) were included in our trial. All included patients receive para-aortic lymph node dissection.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Synchronous Isolated Para-aortic Lymph Node Metastasis, Colorectal Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
39 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Systemic therapy sequenced PALND
Arm Type
Experimental
Arm Description
All received systemtic therapy (at most two lines).
Intervention Type
Procedure
Intervention Name(s)
Para-aortic lymph node dissection
Intervention Description
Para-aortic lymph node dissection was defined as the dissection of para-aortic lymph nodes located below renal vein and above the bifurcation of iliac artery.
Primary Outcome Measure Information:
Title
3-year DFS
Description
Time with no recurrence of the diseases.
Time Frame
From date of recruiment until the date of disease recurrece, assessed up to 3 years
Secondary Outcome Measure Information:
Title
5-year OS
Description
From date of recruitment until the date of death from any cause, assessed up to 5 years.
Time Frame
Up to 5 years
Title
LFS
Description
Time with no recurrence of the paraaortic lymph node region.
Time Frame
From date of recruiment until the date of paraaortic lymph node recurrece, assessed up to 5 years
Title
1-year DFS
Description
Time with no recurrence of the diseases.
Time Frame
From date of recruiment until the date of disease recurrece, assessed up to 1 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age at enrollment is >= 18 and <= 75 years ECOG PS 0-1 Histologically confirmed colorectal carcinoma Synchronous metastatic colorectal cancer with isolated para-aortic lymph node metastases: In the preoperative examination of positron emission tomography CT and abdominopelvic CT, metastasis was noted when the diameter of the PALN was 10 mm or greater and had irregular shape. Single-organ para-aortic lymph node metastasis (PLANM) who are potential to receive surgery and achieve no evidence of disease (NED). Adequate liver, renal and bona marrow function. Signing written informed consent Exclusion Criteria: In addition to PALN metastasis, distant metastases such as lung, liver, peritoneum and bone were presen and in instances when the renal vein was in the upward spread path of the LN metastasis. Unable to achieve NED Clinically severe (ie, active) heart disease, such as symptomatic coronary heart disease, New York Heart Association (NYHA) class II or more severe congestive heart failure or severe arrhythmia requiring medication intervention, Or a history of myocardial infarction in the last 12 months. Those with other history of malignant disease in the last 5 years, except for cured skin cancer and cervical carcinoma in situ. Organ transplantation requires immunosuppressive therapy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Guosheng Wu, MD
Phone
+8617857310313
Email
guosheng_wu@zju.edu.cn
Facility Information:
Facility Name
The First Affiliated Hospital, Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310006
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guosheng Wu, M.D.
Phone
+8617857310313
Email
guosheng_wu@zju.edu.cn

12. IPD Sharing Statement

Plan to Share IPD
No

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Systemic Therapy Sequenced Isolated PALND for mCRC

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