Clinical trial NCT04774757: Systemic Therapy Sequenced Isolated PALND for mCRC
Official title: Curative Systemic Therapy Sequenced Radical Surgery for Synchronous Isolated Paraaortic Lymph Node Metastasis of Colorectal Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Synchronous Isolated Para-aortic Lymph Node Metastasis
Colorectal Cancer
Lead sponsor: First Affiliated Hospital of Zhejiang University
Sponsor class: OTHER
First posted: 2021-03-01
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: 3-year DFS
timeFrame: From date of recruiment until the date of disease recurrece, assessed up to 3 years
Secondary outcomes:
measure: 5-year OS
timeFrame: Up to 5 years
measure: LFS
timeFrame: From date of recruiment until the date of paraaortic lymph node recurrece, assessed up to 5 years
measure: 1-year DFS
timeFrame: From date of recruiment until the date of disease recurrece, assessed up to 1 years
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The First Affiliated Hospital, Zhejiang University School of Medicine
state: Zhejiang
Study officials:
References: