CtDNA-guided Selection of Adjuvant Chemotherapy Regimens for Elderly Colon Cancer Patients After Surgery: a Single-center, Randomized, Controlled Study (ZJCH-CRCC-1)

September 22, 2024 updated by: Zhu Yuping, Zhejiang Cancer Hospital

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This study is a prospective, randomized controlled trial designed to explore the disease-free survival period of elderly patients with high-risk stage II and stage III colon cancer based on ctDNA detection.

  1. Screening Phase Complete the routine pre-enrollment evaluation of subjects, such as medical history, pathological staging, and treatment history. Researchers will assess whether subjects meet the enrollment criteria (see inclusion and exclusion criteria). For subjects who meet the enrollment criteria, the attending physician will inform the subjects and their families, explaining the purpose, advantages, disadvantages, and the entire research process of this clinical trial. They will seek the opinions of the subjects and their families, and obtain signed informed consent from the subjects.

    Researchers need to collect baseline postoperative tissue samples for detection, which will be used for the customization of personalized probes for subsequent blood tests.

  2. Adjuvant Therapy/Follow-up Phase Elderly colorectal cancer patients who meet the inclusion and exclusion criteria will undergo ctDNA-MRD testing after surgery. ctDNA-negative patients will be randomly divided into two groups in a 1:1 ratio: 1) Observation and follow-up; 2) 6-month adjuvant chemotherapy with 5-FU monotherapy. Patients who test positive for ctDNA will be randomly assigned in a 1:1 ratio to receive: 1) 6 months of 5-FU monotherapy; 2) XELOX intensive treatment group. The follow-up strategy is the same for all four groups, 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 half a year after surgery.
  3. Management Measures for Subjects with Disease Progression If a patient experiences disease progression, efforts should be made to continue tracking and recording the patient's subsequent anti-tumor treatment and survival outcomes, including local and/or systemic therapy.

Study Type

Interventional

Enrollment (Estimated)

312

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Yuping Zhu, M.D.
  • Phone Number: 86-0571-88128011
  • Email: drzyp@163.com

Study Contact Backup

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310000
        • Recruiting
        • Zhejiang Cancer Hospital
        • Contact:
          • Yuping Zhu, M.D.
          • Phone Number: 86-0571-88128011
          • Email: drzyp@163.com
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. 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.
  2. Patients who have had a history of malignant tumors within 5 years.
  3. 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).
  4. Patients suffering from severe mental illnesses.
  5. Patients who have participated in other clinical trials within 30 days prior to screening.
  6. Patients who are unable to undergo adjuvant chemotherapy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
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.
Experimental: Arm-C
Patients with positive ctDNA; 6-month adjuvant chemotherapy with 5-FU monotherapy
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.
Experimental: Arm-D
Patients with positive ctDNA; XELOX intensive treatment group
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
2-year DFS (Disease-Free Survival)
Time Frame: From enrollment to the end of treatment at 2 years
Disease-free survival (DFS): the time from the start of treatment to the progression of the disease.
From enrollment to the end of treatment at 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
5-year DFS (Disease-Free Survival)
Time Frame: From enrollment to the end of treatment at 5 years
Disease-free survival (DFS): the time from the start of treatment to the progression of the disease.
From enrollment to the end of treatment at 5 years
2-year OS (Overall Survival)
Time Frame: From enrollment to the end of treatment at 2 years
Overall Survival (OS) refers to the total survival time from the start of treatment until death directly caused by the disease.
From enrollment to the end of treatment at 2 years
5-year OS (Overall Survival)
Time Frame: From enrollment to the end of treatment at 5 years
Overall Survival (OS) refers to the total survival time from the start of treatment until death directly caused by the disease.
From enrollment to the end of treatment at 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhejiang Cancer Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 3, 2024

Primary Completion (Estimated)

December 31, 2029

Study Completion (Estimated)

December 31, 2034

Study Registration Dates

First Submitted

September 22, 2024

First Submitted That Met QC Criteria

September 22, 2024

First Posted (Actual)

September 24, 2024

Study Record Updates

Last Update Posted (Actual)

September 24, 2024

Last Update Submitted That Met QC Criteria

September 22, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-2024-380

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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