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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 70
Maximum Age: 80
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Zhejiang Cancer Hospital
RECRUITING
Hangzhou
Contact Information
Primary
Yuping Zhu, M.D.
drzyp@163.com
86-0571-88128011
Backup
Yibo Cai, M.D.
caiyiyibo@zju.edu.cn
86-0571-88128011
Time Frame
Start Date: 2024-07-03
Estimated Completion Date: 2034-12-31
Participants
Target number of participants: 312
Treatments
No_intervention: Arm-A
Patients with negative ctDNA;Observation and follow-up
Experimental: Arm-B
Patients with negative ctDNA;6-month adjuvant chemotherapy with 5-FU monotherapy
Experimental: Arm-C
Patients with positive ctDNA; 6-month adjuvant chemotherapy with 5-FU monotherapy
Experimental: Arm-D
Patients with positive ctDNA; XELOX intensive treatment group
Related Therapeutic Areas
Sponsors
Leads: Zhejiang Cancer Hospital

This content was sourced from clinicaltrials.gov