Actively Recruiting
Circulating Tumor DNA Methylation Guided Postoperative Adjuvant Chemotherapy for High-risk Stage II/III Colorectal Cancer: A Multicenter, Prospective, Randomized Controlled Cohort Study (FINE Trial)
Led by Fudan University · Updated on 2024-05-20
340
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Colorectal cancer (CRC) is a common and serious gastrointestinal cancer with high incidence and mortality worldwide. Early-stage patients have a good survival rate, but high-risk stage II and III patients face lower survival and frequent recurrence. This research evaluates the use of circulating tumor DNA (ctDNA) methylation to guide postoperative adjuvant chemotherapy in high-risk stage II and III CRC patients, aiming to improve treatment outcomes by tailoring chemotherapy based on ctDNA status. Participants receive one of two chemotherapy regimens: mFOLFIRINOX or mFOLFOX6/XELOX. Treatment starts with 6 cycles of mFOLFIRINOX every two weeks or 6 cycles of mFOLFOX6 every two weeks or 4 cycles of XELOX every three weeks. After initial chemotherapy, blood tests check ctDNA methylation. If ctDNA remains positive, additional cycles are given; if negative, patients receive maintenance chemotherapy with capecitabine every 21 days for 4 cycles. Throughout the study, patients undergo regular plasma ctDNA methylation testing to measure ctDNA clearance rates after 3 and 6 months of chemotherapy. Researchers also monitor disease-free survival, overall survival, adverse events, and treatment completion rates over several years. This multicenter, randomized study involves detailed blood tests, imaging scans, and clinical assessments to evaluate how ctDNA-guided chemotherapy affects patient prognosis and safety over time.
CONDITIONS
Brief Title
Circulating Tumor DNA Methylation Guided Postoperative Adjuvant Chemotherapy for High-risk Stage II/III Colorectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histopathologically diagnosed with colorectal adenocarcinoma
- Underwent radical curative surgery for the primary tumor
- Diagnosed with high-risk stage II or stage III colorectal cancer based on UICC TNM Classification, 8th Edition
- Positive for ctDNA methylation 5-7 days after surgery before enrollment
- No obvious relapse confirmed by chest, abdominal, and pelvic CT scans
- Aged between 18 and 80 years, any gender
- Expected survival of more than 12 months
- Eastern Cooperative Oncology Group performance status of 0 or 1
- No severe disorder in major organs and meet blood count and liver/kidney function criteria
- No diarrhea or stomatitis of Grade 2 or higher according to CTCAE v5.0
- Provided voluntary written consent after thorough explanation of the trial
You will not qualify if you...
- Received neoadjuvant therapy before surgery
- Blood transfusion during or within 2 weeks before surgery
- Incomplete baseline plasma samples pre- or post-operation
- Pregnant or lactating women without adequate contraception
- History of other malignant tumors within 5 years except cured cervical carcinoma in situ or non-melanoma skin cancer
- Uncontrolled primary brain tumor or central nervous system metastasis with symptoms
- Serious or uncontrolled diseases such as unstable heart disease, neuropathy, psychosis, severe infection, bleeding disorders
- Significant impairment of important organ function
- Any other condition deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Approximately 3 to 6 months depending on treatment response
Participants receive adjuvant chemotherapy based on their assigned group. One group receives mFOLFIRINOX every two weeks for 6 cycles, potentially extended to 12 cycles depending on ctDNA status, followed by maintenance capecitabine. The other group receives mFOLFOX6 every two weeks for 6 cycles or XELOX every three weeks for 4 cycles, with possible additional cycles based on ctDNA status, followed by maintenance capecitabine.
Visits every 2 or 3 weeks during chemotherapy cycles and maintenance therapy
Trial Site Locations
Total: 1 location
1
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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