Systemic Therapy Sequenced Isolated PALND for mCRC

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

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.

Study Overview

• Status: Recruiting
• Conditions: Colorectal Cancer; Synchronous Isolated Para-aortic Lymph Node Metastasis
• Intervention / Treatment: Procedure: Para-aortic lymph node dissection

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 Type: Interventional
• Enrollment (Anticipated): 39
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Guosheng Wu, MD; Phone Number: +8617857310313; Email: guosheng_wu@zju.edu.cn

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310006
      • Recruiting
      • The First Affiliated Hospital, Zhejiang University School of Medicine
      • Contact: Guosheng Wu, M.D.; Phone Number: +8617857310313; Email: guosheng_wu@zju.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Systemic therapy sequenced PALND; All received systemtic therapy (at most two lines).	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
5-year OS	From date of recruitment until the date of death from any cause, assessed up to 5 years.	Up to 5 years
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
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

Collaborators and Investigators

• Sponsor: First Affiliated Hospital of Zhejiang University

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2021
• Primary Completion (Anticipated): March 1, 2023
• Study Completion (Anticipated): March 1, 2026

Study Registration Dates

• First Submitted: February 25, 2021
• First Submitted That Met QC Criteria: February 25, 2021
• First Posted (Actual): March 1, 2021

Study Record Updates

• Last Update Posted (Actual): October 11, 2021
• Last Update Submitted That Met QC Criteria: October 4, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Neoplastic Processes; Colorectal Neoplasms; Neoplasm Metastasis; Lymphatic Metastasis
• Other Study ID Numbers: Synchronous isolated PALND

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No