Status:
RECRUITING
Systemic Therapy Sequenced Isolated PALND for mCRC
Lead Sponsor:
First Affiliated Hospital of Zhejiang University
Conditions:
Synchronous Isolated Para-aortic Lymph Node Metastasis
Colorectal Cancer
Eligibility:
All Genders
18-75 years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- Age at enrollment is \>= 18 and \<= 75 years
- ECOG PS 0-1
- Histologically confirmed colorectal carcinoma
- 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.
- Single-organ para-aortic lymph node metastasis (PLANM) who are potential to receive surgery and achieve no evidence of disease (NED).
- Adequate liver, renal and bona marrow function.
- Signing written informed consent
Exclusion
- 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.
- Unable to achieve NED
- 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.
- Those with other history of malignant disease in the last 5 years, except for cured skin cancer and cervical carcinoma in situ.
- Organ transplantation requires immunosuppressive therapy
Key Trial Info
Start Date :
March 10 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2026
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT04774757
Start Date
March 10 2021
End Date
March 1 2026
Last Update
October 11 2021
Active Locations (1)
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1
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310006