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

NCT06609551 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 312

Last updated 2024-09-24

No results posted yet for this study

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.

Conditions

Interventions

DRUG

6-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.

DRUG

XELOX 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.

Sponsors & Collaborators

  • Zhejiang Cancer Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
70 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-03
Primary Completion
2029-12-31
Completion
2034-12-31

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06609551 on ClinicalTrials.gov