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

NCT06167967 | Recruiting

• 2 other identifiers: SRRS-cmPATSRRS2023-0704
• Study Type: interventional
• Target: 990
• Locations: 1 country
• Sites: 1

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

Conditions

Colorectal Cancer

Keywords

colorectal cancer; ctDNA methylation; adjuvant chemotherapy

Outcome Measures

Primary Outcomes (1)

• Recurrence-free survival at 3 years

  3 years

Secondary Outcomes (3)

• Overall survival at 5 years

  5 years

• ctDNA clearance rate in ctDNA-positive patients treated with adjuvant chemotherapy

  6 months

• The proportion of patients in the low-risk cohort who did not receive adjuvant chemotherapy

  6 months

Study Arms (2)

ctDNA-guided group

EXPERIMENTAL

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.

Diagnostic Test: ctDNA methylation

standard treatment group

ACTIVE COMPARATOR

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.

Diagnostic Test: standard treatment

Interventions

ctDNA methylation 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.

ctDNA-guided group

standard treatment DIAGNOSTIC_TEST

This group was treated according to standard procedure

standard treatment group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old ≤ age \< 75 years old.
• Stage III (T1-4, N1-2, M0) colorectal cancer patients.
• Patients who can undergo R0 resection.
• ECOG score 0 \~ 2.
• Expected survival ≥ 6 months.
• No history of other malignant tumors.
• 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.

You may not qualify if:

• Patients who have received neoadjuvant chemotherapy.
• Known high clinical risk of adjuvant chemotherapy.
• Patients with clear contraindications to adjuvant chemotherapy (i.e. due to physical condition, comorbidities, active second cancer, or age).
• Patients who are unable to undergo subsequent chemotherapy due to other reasons (travel distance, compliance).
• Vulnerable groups, including people with mental illness, people with cognitive impairment, critically ill patients, minors, pregnant women, etc.

Sponsors & Collaborators

• Sir Run Run Shaw Hospital: lead

Study Sites (1)

Sir Run Run Shao hospital

Hanzhou, Zhejiang, 310016, China

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Zhangfa Song, Dr

  Sir Run Run Shaw Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bingjun Bai, Dr

CONTACT

+8613858816897; echobai@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice director

Study Record Dates

• First Submitted: December 4, 2023
• First Posted: December 13, 2023
• Study Start: April 8, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2029
• Last Updated: May 17, 2024

Record last verified: 2024-05

Locations

CN (1)