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; 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

Inclusion Criteria5

Patients aged 70-80, both male and female are eligible;
Patients with histopathologically confirmed stage II high-risk or stage III colon cancer;
Patients with an ECOG score of ≤2;
Patients who are required to undergo tissue genetic testing;
Subjects who voluntarily participate in this study, sign the informed consent form, have good compliance, and cooperate with follow-up visits.

Exclusion Criteria6

Patients with one or more severe concomitant systemic diseases that, in the investigator\'s opinion, would impair the patient\'s ability to complete the study.
Patients who have had a history of malignant tumors within 5 years.
Any unstable systemic disease (including active infection, poorly controlled diabetes, poorly controlled hypertension, unstable angina, congestive heart failure, myocardial infarction within one year, severe arrhythmia requiring medical treatment, liver, kidney, or metabolic diseases).
Patients suffering from severe mental illnesses.
Patients who have participated in other clinical trials within 30 days prior to screening.
Patients who are unable to undergo adjuvant chemotherapy.

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.