Actively Recruiting
Circulating Tumor DNA Methylation Guided Postoperative Adjuvant Chemotherapy for High-risk Stage II/III Colorectal Cancer
Led by Fudan University · Updated on 2024-05-20
340
Participants Needed
1
Research Sites
252 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Colorectal cancer (CRC) is one of the most common gastrointestinal tumors. According to the latest cancer report, the incidence and mortality rates of CRC are both ranked top 5 among malignant tumors worldwide and continue to rise. Patients who receive treatment in the early stage (stage I) have a 5-year survival rate of approximately 90%. However, for high-risk stage II and III colorectal cancer patients, the 5-year survival rate is only 40%-70%, and almost half of the patients experience postoperative recurrence and metastasis. Evidence suggests that Stage III CRC patients can benefit from standard adjuvant chemotherapy. It is worth noting that some high-risk stage II patients, especially those with T4N0, have a poorer prognosis compared to stage IIIA (T1-2N+). Adjuvant chemotherapy is now also recommended for postoperative cases of high-risk stage II CRC. Given the high effectiveness of the three-drug FOLFOXIRI regimen in treating metastatic CRC and the success of adjuvant chemotherapy in treating pancreatic cancer, the combination of 5-fluorouracil, oxaliplatin, and irinotecan may have a synergistic effect. Extensive study results have shown that: (a) The status of ctDNA methylation after surgery is significantly correlated with patient prognosis, and patients who are positive for ctDNA methylation in the first 1-4 weeks after surgery (before adjuvant chemotherapy) have a poor prognosis. (b) Patients who are ctDNA methylation positive in the first 1-4 weeks after surgery (before adjuvant chemotherapy) can benefit from adjuvant chemotherapy, and achieving ctDNA methylation negativity through adjuvant chemotherapy significantly improves patient prognosis. This project focuses on exploring the optimized mode of postoperative adjuvant chemotherapy for high-risk stage II and III CRC guided by ctDNA methylation, which has high scientific and innovative value. This multicenter, prospective, and randomized controlled cohort study uses a single-tube methylation-specific quantitative PCR (mqMSP) detection, which detects 10 different methylation markers and can quantitatively analyze plasma samples containing tumor DNA as low as 0.05%. This study will use this ctDNA methylation detection technology to perform quantitative detection of ctDNA methylation in the plasma of enrolled patients, and explore the effect of different chemotherapy regimens on ctDNA clearance rate and the prognostic value for ctDNA positive patients. We hope to screen out high-risk populations for recurrence through postoperative ctDNA testing, and administer more intensive chemotherapy regimens (chemotherapy upgrading) as early as possible to improve ctDNA clearance rate and patient prognosis.
CONDITIONS
Official 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...
- Histopathological diagnosis of colorectal adenocarcinoma
- Radical curative resection of primary tumors completed
- Diagnosis of high-risk stage II or stage III colorectal cancer based on UICC TNM 8th Edition
- Positive ctDNA methylation test 5-7 days after surgery before enrollment
- No signs of relapse confirmed by chest, abdominal, and pelvic CT scans
- Age between 18 and 80 years, any gender
- Expected survival longer than 12 months
- ECOG performance status of 0 or 1
- No severe major organ disorders with specific blood and liver function counts within defined limits
- No diarrhea or stomatitis of Grade 2 or higher per CTCAE v5.0
- Provided voluntary written informed consent after full explanation
You will not qualify if you...
- Neoadjuvant therapy received before surgery
- Blood transfusion during or within 2 weeks before surgery
- Incomplete baseline plasma samples including preoperative and 5-7 days postoperative samples
- Pregnant or breastfeeding 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 uncontrollable diseases including severe heart disease within 6 months, neuropathy, psychosis, severe infection, active disseminated intravascular coagulation, or bleeding tendency
- Significant impairment of important organ function
- Other conditions deemed unsuitable for trial participation by investigators
AI-Screening
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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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