Systemic Therapy Sequenced Isolated PALND for mCRC

NCT ID: NCT04774757

Last Updated: 2021-10-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-10
• Study Completion Date: 2026-03-01

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.

Conditions

Synchronous Isolated Para-aortic Lymph Node Metastasis; Colorectal Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Systemic therapy sequenced PALND

All received systemtic therapy (at most two lines).

Group Type: EXPERIMENTAL

Para-aortic lymph node dissection

Intervention Type: PROCEDURE

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.

Interventions

Para-aortic lymph node dissection

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

First Affiliated Hospital of Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Guosheng Wu

Chief physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Guosheng Wu, MD

Role: CONTACT

guosheng_wu@zju.edu.cn

+8617857310313

Facility Contacts

Guosheng Wu, M.D.

Role: primary

guosheng_wu@zju.edu.cn

+8617857310313

Other Identifiers

Synchronous isolated PALND

Identifier Type: -

Identifier Source: org_study_id