Treatment for colorectal cancer with isolated para-aortic lymph node metastasis
Curative Systemic Therapy Sequenced Radical Surgery for Synchronous Isolated Paraaortic Lymph Node Metastasis of Colorectal Cancer
This study is testing a new treatment plan that combines medication and surgery for people with colorectal cancer that has spread to nearby lymph nodes to see if it helps them live better and longer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 39 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | First Affiliated Hospital of Zhejiang University Academic / other |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Trial ID | NCT04774757 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness and safety of a treatment approach that combines systemic therapy followed by radical surgery for patients with synchronous isolated para-aortic lymph node metastasis of colorectal cancer. Eligible patients will receive up to two lines of systemic therapy, and those who show potential for achieving no evidence of disease will undergo para-aortic lymph node dissection. The study aims to determine if this sequenced treatment can improve patient outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with histologically confirmed colorectal cancer and isolated para-aortic lymph node metastasis who can potentially achieve no evidence of disease.
Not a fit: Patients with additional distant metastases or those unable to achieve no evidence of disease will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved survival rates and quality of life for patients with this specific type of colorectal cancer metastasis.
How similar studies have performed: While there is limited data on this specific approach, similar strategies combining systemic therapy with surgical intervention have shown promise in other studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Hangzhou, Zhejiang
- The First Affiliated Hospital, Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (Recruiting)
Study contacts
- Study coordinator: Guosheng Wu, MD
- Email: guosheng_wu@zju.edu.cn
- Phone: +8617857310313
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.