Systemic Therapy Sequenced Isolated PALND for mCRC

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04774757
• Other study ID #: Synchronous isolated PALND
• Status: Recruiting
• Phase: N/A
• Start date: March 10, 2021
• Est. completion date: March 1, 2026

Study information

• Verified date: October 2021
• Source: First Affiliated Hospital of Zhejiang University
• Contact: Guosheng Wu, MD
• Phone: +8617857310313
• Email: guosheng_wu[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 39
• Est. completion date: March 1, 2026
• Est. primary completion date: March 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Lymphatic Metastasis
• Neoplasm Metastasis

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
China	The First Affiliated Hospital, Zhejiang University School of Medicine	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital of Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	3-year DFS	Time with no recurrence of the diseases.	From date of recruiment until the date of disease recurrece, assessed up to 3 years
Secondary	5-year OS	From date of recruitment until the date of death from any cause, assessed up to 5 years.	Up to 5 years
Secondary	LFS	Time with no recurrence of the paraaortic lymph node region.	From date of recruiment until the date of paraaortic lymph node recurrece, assessed up to 5 years
Secondary	1-year DFS	Time with no recurrence of the diseases.	From date of recruiment until the date of disease recurrece, assessed up to 1 years