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Clinical Trials/NCT04774757
NCT04774757RecruitingNot Applicable

Curative Systemic Therapy Sequenced Radical Surgery for Synchronous Isolated Paraaortic Lymph Node Metastasis of Colorectal Cancer

First Affiliated Hospital of Zhejiang University1 site in 1 country39 target enrollmentStarted: March 10, 2021Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
39
Locations
1
Primary Endpoint
3-year DFS
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Systemic therapy sequenced PALND

Experimental

All received systemtic therapy (at most two lines).

Intervention: Para-aortic lymph node dissection (Procedure)

Outcomes

Primary Outcomes

3-year DFS

Time Frame: From date of recruiment until the date of disease recurrece, assessed up to 3 years

Time with no recurrence of the diseases.

Secondary Outcomes

  • 1-year DFS(From date of recruiment until the date of disease recurrece, assessed up to 1 years)
  • LFS(From date of recruiment until the date of paraaortic lymph node recurrece, assessed up to 5 years)
  • 5-year OS(Up to 5 years)

Investigators

Sponsor
First Affiliated Hospital of Zhejiang University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Guosheng Wu

Chief physician

First Affiliated Hospital of Zhejiang University

Study Sites (1)

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