RecruitingPhase 3NCT06609551

ctDNA-guided Selection of Adjuvant Chemotherapy Regimens for Elderly Colon Cancer Patients After Surgery: A Single-center, Randomized, Controlled Study

Sponsor

Zhejiang Cancer Hospital

Enrollment

312 participants

Start Date

Jul 3, 2024

Study Type

INTERVENTIONAL

Conditions

Colon Cancer Colon Cancer (Stage II &Amp;Amp;Amp; III)

Summary

The goal of this clinical trial is to explore the disease-free survival period of elderly patients with high-risk stage II and stage III colon cancer based on ctDNA detection. The main questions it aims to answer are: Can ctDNA detection effectively guide the assessment of disease-free survival in elderly patients with high-risk stage II and stage III colon cancer? What is the correlation between postoperative ctDNA status and patient imaging as well as prognosis in elderly patients? Secondary objectives include: Evaluating the correlation between postoperative ctDNA status and patient imaging, as well as prognosis, in elderly patients. Analyzing the positive rate of postoperative ctDNA and the ctDNA clearance rate. Additionally, an exploratory objective of this study is to investigate recurrence models for postoperative patients. Participants will undergo ctDNA testing to assess their disease status and will be monitored for disease-free survival. Imaging studies will also be conducted to correlate with ctDNA findings. The study aims to gain a deeper understanding of the role of ctDNA in predicting prognosis and monitoring disease recurrence in elderly patients with colon cancer.

Eligibility

Min Age: 70 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a blood test called ctDNA (circulating tumor DNA — cancer DNA found in the bloodstream) can help doctors choose the right chemotherapy regimen for elderly colon cancer patients after surgery. The goal is to personalize treatment decisions for patients between 70 and 80 years old, who often face different risks from chemotherapy. **You may be eligible if...** - You are between 70 and 80 years old - You have been diagnosed with high-risk Stage II or Stage III colon cancer confirmed by biopsy - You are in reasonably good physical condition - You are willing to undergo genetic testing of your tumor **You may NOT be eligible if...** - You have serious co-existing illnesses that would prevent completion of the study - You had another cancer in the past 5 years - You have poorly controlled diabetes, high blood pressure, or other unstable medical conditions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUG6-month adjuvant chemotherapy with 5-FU monotherapy

6 months of adjuvant chemotherapy with 5-FU monotherapy. The follow-up strategy for the four groups of subjects will be the same, including but not limited to chest plain or enhanced CT, abdominal/pelvic enhanced CT, and detection of the tumor marker carcinoembryonic antigen (CEA), until disease progression occurs. All patients will undergo peripheral blood ctDNA-MRD testing again six months after surgery.

DRUGXELOX intensive treatment group

XELOX intensive treatment group. The follow-up strategy for the four groups of subjects will be the same, including but not limited to chest plain or enhanced CT, abdominal/pelvic enhanced CT, and detection of the tumor marker carcinoembryonic antigen (CEA), until disease progression occurs. All patients will undergo peripheral blood ctDNA-MRD testing again six months after surgery.