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Systemic Therapy Sequenced Isolated PALND for mCRC | Clinical Trials | Clareo Health

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Systemic Therapy Sequenced Isolated PALND for mCRC

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

NCT04774757•First Affiliated Hospital of Zhejiang University

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 75 years

Sex

ALL

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

Locations (1)

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Key Dates

Start Date

March 10, 2021

Primary Completion Date

March 1, 2023

Completion Date

March 1, 2026

Last Updated

October 11, 2021

Enrollment

ESTIMATED participants

Conditions

Synchronous Isolated Para-aortic Lymph Node MetastasisColorectal Cancer

Interventions

Para-aortic lymph node dissection

PROCEDURE

Contacts

Guosheng Wu, MD

CONTACT

+8617857310313 guosheng_wu@zju.edu.cn

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 11, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Systemic Therapy Sequenced Isolated PALND for mCRC

Inclusion Criteria

Exclusion Criteria

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