Systemic Therapy Sequenced Isolated PALND for mCRC

First Affiliated Hospital of Zhejiang University39 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Synchronous Isolated Para-aortic Lymph Node Metastasis Colorectal Cancer

Interventions

Para-aortic lymph node dissectionPROCEDURE

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

RECRUITING

Outcomes

Primary Outcomes

3-year DFS

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 Outcomes

5-year OS

From date of recruitment until the date of death from any cause, assessed up to 5 years.

Time frame: Up to 5 years

LFS

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

1-year DFS

Time with no recurrence of the diseases.

Time frame: From date of recruiment until the date of disease recurrece, assessed up to 1 years

Central Contacts

Guosheng Wu, MD

CONTACT

+8617857310313 guosheng_wu@zju.edu.cn

Data from ClinicalTrials.gov

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