Systemic Therapy Sequenced Isolated PALND for mCRC

Launched by FIRST AFFILIATED HOSPITAL OF ZHEJIANG UNIVERSITY · Feb 25, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for patients with colorectal cancer that has spread to specific lymph nodes in the abdominal area, known as para-aortic lymph nodes. The goal is to find out if using a combination of medicine (systemic therapy) followed by surgery can effectively treat this type of cancer and ensure patients have no signs of the disease afterward. The trial is currently looking for participants who are between 18 and 75 years old, have a confirmed diagnosis of colorectal cancer, and have isolated metastases in their para-aortic lymph nodes that are large enough to be treated.

To be eligible for the trial, participants need to be generally healthy, meaning they should have good liver, kidney, and bone marrow function and not have other serious health conditions or additional cancer. If you decide to join the study, you can expect to receive a treatment plan that includes both medication and possible surgery, with careful monitoring for safety and effectiveness. Your involvement in this trial could help researchers learn more about how to best treat this challenging condition.

Gender

ALL

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