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

Официальное название

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

Обзор

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.

Вмешательства

• Диагностический тест 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.
• Диагностический тест standard treatment
  This group was treated according to standard procedure

Первичные конечные точки

• Recurrence-free survival at 3 years [Срок оценки: 3 years]

Вторичные конечные точки (3)

• Overall survival at 5 years [Срок оценки: 5 years]
• ctDNA clearance rate in ctDNA-positive patients treated with adjuvant chemotherapy [Срок оценки: 6 months]
• The proportion of patients in the low-risk cohort who did not receive adjuvant chemotherapy [Срок оценки: 6 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

Китай · 1 центр

• Sir Run Run Shao hospital — Hanzhou

Идентификаторы

NCT: NCT06167967 · SRRS-cmPAT · SRRS2023-0704

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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