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NCT Number: NCT06167967

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

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.

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sir Run Run Shao hospital

Hanzhou, Zhejiang, 310016, China

Location status: Recruiting

Location contact

Zhangfa Song, Dr

CONTACT

[email protected]

+86 13867421652

Zhangfa Song, doctor

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 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.

Exclusion criteria

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

Treatment and study plan

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.

standard treatment

Diagnostic Test

This group was treated according to standard procedure

Primary outcomes

  1. Recurrence-free survival at 3 years

    Time frame: 3 years

Secondary outcomes

  1. Overall survival at 5 years

    Time frame: 5 years

  2. ctDNA clearance rate in ctDNA-positive patients treated with adjuvant chemotherapy

    Time frame: 6 months

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

    Time frame: 6 months

Study contacts

Contact information is provided by the study sponsor or research team.

Bingjun Bai, Dr

CONTACT

[email protected]

+8613858816897

Sponsors and collaborators

Lead sponsor

Sir Run Run Shaw Hospital

Other

Registry information

Official study title

Circulating Tumor DNA Methylation Guiding Postoperative Adjuvant Chemotherapy in Stage III Colorectal Cancer: a Multicenter, Randomized Controlled Trial

Acronym: cmPAT

Important dates

Study start
2024
Primary completion
2026
Study completion
2029
First posted
Dec 13, 2023
Registry last updated
May 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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