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

Phase 3

Recruiting

• Conditions: Colon Cancer; Colon Cancer (stage II & III)
• Interventions: Drug: 6-month adjuvant chemotherapy with 5-FU monotherapy; Drug: XELOX intensive treatment group

• Registration Number: NCT06609551
• Lead Sponsor: Zhejiang Cancer Hospital

Brief 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:
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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.
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Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2024-07-03
• Status Verified: 2024-09
• Study First Submitted: 2024-09-22
• Study First Submitted QC: 2024-09-22
• Last Update Submitted: 2024-09-22
• Study First Posted: 2024-09-24
• Last Update Posted: 2024-09-24
• Primary Completion: 2029-12-31
• Study Completion: 2034-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 312

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm-B	6-month adjuvant chemotherapy with 5-FU monotherapy	Patients with negative ctDNA;6-month adjuvant chemotherapy with 5-FU monotherapy
Arm-C	6-month adjuvant chemotherapy with 5-FU monotherapy	Patients with positive ctDNA; 6-month adjuvant chemotherapy with 5-FU monotherapy
Arm-D	XELOX intensive treatment group	Patients with positive ctDNA; XELOX intensive treatment group

Primary Outcome Measures

Name	Time	Method
2-year DFS (Disease-Free Survival)	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.

Secondary Outcome Measures

Name	Time	Method
5-year DFS (Disease-Free Survival)	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.
2-year OS (Overall Survival)	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.
5-year OS (Overall Survival)	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.

Trial Locations

Locations (1)

Zhejiang Cancer Hospital; 🇨🇳 Hangzhou, Zhejiang, China