Circulating Tumor DNA Methylation Guiding Postoperative Adjuvant Chemotherapy in Stage III Colorectal Cancer

NCT ID: NCT06167967

Last Updated: 2024-05-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 990 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-08
• Study Completion Date: 2029-12-31

Brief Summary

The goal of this randomized controlled trial is to investigate whether ctDNA methylation is a more precise indicator to guide postoperative adjuvant chemotherapy in stage Ill colorectal cancer. The main questions it aims to answer are:

1. Whether ctDNA methylation-guided escalation strategy is superior to standard treatment for stage III high-risk CRC patients.

2. Whether ctDNA methylation-guided de-escalation strategy is non-inferior to standard treatment for stage III low-risk CRC patients.

325 cases were included in the high-risk cohort (T4 and/or N2) and 665 cases were included in the low-risk cohort (T1-T3, N1). Then patients in each cohort were randomly assigned to ctDNA-guided treatment (ctDNA-guided group) and standard treatment (standard treatment group) in a ratio of 2:1. The standard treatment group and ctDNA-negative group in the high-risk cohort were treated with XELOX regimen for 6 months, and the ctDNA-positive group in the high-risk cohort was treated with cmFOLFOXIRI regimen for 6 months. The standard treatment group and the ctDNA-positive group in the low-risk cohort were treated with XELOX regimen for 3 months, while the ctDNA-negative group in the low-risk cohort did not receive adjuvant chemotherapy.

Conditions

Colorectal Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

ctDNA-guided group

ctDNA-negative group in the high-risk cohort were treated with XELOX regimen for 6 months; ctDNA-positive group in the high-risk cohort was treated with cmFOLFOXIRI regimen for 6 months; ctDNA-positive group in the low-risk cohort were treated with XELOX regimen for 3 months; ctDNA-negative group in the low-risk cohort did not receive adjuvant chemotherapy.

Group Type: EXPERIMENTAL

ctDNA methylation

Intervention Type: DIAGNOSTIC_TEST

A blood-based circulating tumor DNA methylation assay that uses 6 different methylation markers, SEPT9 region1, SEPT9 region2, BCAT1, IKZF1, BCAN and VAV3.

standard treatment group

The standard treatment group in the high-risk cohort were treated with XELOX regimen for 6 months, and in the low-risk cohort were treated with XELOX regimen for 3 months.

Group Type: ACTIVE_COMPARATOR

standard treatment

Intervention Type: DIAGNOSTIC_TEST

This group was treated according to standard procedure

Interventions

ctDNA methylation

A blood-based circulating tumor DNA methylation assay that uses 6 different methylation markers, SEPT9 region1, SEPT9 region2, BCAT1, IKZF1, BCAN and VAV3.

Intervention Type: DIAGNOSTIC_TEST

standard treatment

This group was treated according to standard procedure

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

1. 18 years old ≤ age < 75 years old.

2. Stage III (T1-4, N1-2, M0) colorectal cancer patients.

3. Patients who can undergo R0 resection.

4. ECOG score 0 ~ 2.

5. Expected survival ≥ 6 months.

6. No history of other malignant tumors.

7. Voluntarily participate in this study and sign the informed consent. If the subject does not have the ability to read the informed consent (e.g., illiterate subjects), a witness must witness the informed process and sign the informed consent.

Exclusion Criteria

1. Patients who have received neoadjuvant chemotherapy.

2. Known high clinical risk of adjuvant chemotherapy.

3. Patients with clear contraindications to adjuvant chemotherapy (i.e. due to physical condition, comorbidities, active second cancer, or age).

4. Patients who are unable to undergo subsequent chemotherapy due to other reasons (travel distance, compliance).

5. Vulnerable groups, including people with mental illness, people with cognitive impairment, critically ill patients, minors, pregnant women, etc.

6. There are any other circumstances that the researcher deems unsuitable for inclusion.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sir Run Run Shaw Hospital

OTHER

Sponsor Role: lead

Responsible Party

Zhangfa Song

Vice director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zhangfa Song, Dr

Role: PRINCIPAL_INVESTIGATOR

Sir Run Run Shaw Hospital

Locations

Sir Run Run Shao hospital

Hanzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Bingjun Bai, Dr

Role: CONTACT

echobai@zju.edu.cn

+8613858816897

Facility Contacts

Zhangfa Song, Dr

Role: primary

songzhangfa@zju.edu.cn

+86 13867421652

Other Identifiers

SRRS2023-0704

Identifier Type: REGISTRY

Identifier Source: secondary_id

SRRS-cmPAT

Identifier Type: -

Identifier Source: org_study_id