Using circulating tumor DNA to guide chemotherapy for colon cancer
Circulating Tumor DNA Guided Adjuvant Chemotherapy for Colon Cancer: A Prospective, Multicenter, Open-label, Randomized Controlled Clinical Trial
This study tests if using blood samples to check for cancer DNA can help doctors decide how much chemotherapy colon cancer patients really need to improve their treatment outcomes.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 2684 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Peking University Cancer Hospital & Institute Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT05529615 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of using circulating tumor DNA (ctDNA) to guide adjuvant chemotherapy decisions in patients with colon cancer. It focuses on classifying patients based on their risk levels and ctDNA status to optimize treatment duration and improve outcomes. By analyzing postoperative ctDNA, the study seeks to identify patients who may benefit from reduced chemotherapy without compromising survival. The approach is based on previous findings that suggest ctDNA can serve as a predictive marker for recurrence risk.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with stage II or III colon adenocarcinoma and specific high-risk factors.
Not a fit: Patients with distant metastasis or those with certain genetic mutations may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more personalized chemotherapy regimens, reducing unnecessary treatment for low-risk patients while ensuring high-risk patients receive adequate care.
How similar studies have performed: Previous studies have shown promising results using ctDNA for monitoring and treatment decisions in colon cancer, indicating a potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age: 18 to 75 2. Colon adenocarcinoma confirmed by pathology (including high and high differentiated tubular adenocarcinoma, papillary adenocarcinoma, low differentiated adenocarcinoma, mucinous adenocarcinoma and signet ring cell carcinoma) 3. Postoperative pathology is stage II with high-risk factors or stage III; High risk stage II refers to stage II colon cancer with at least one of the following: a) T4 stage; b) The number of lymph nodes detected was less than 12; c) Poor differentiation (except MSI-H); d) Complicated with LVI or PNI；e) Complicated with obstruction or perforation. 4. No distant metastasis was found in preoperative imaging examination and operation; 5. ECOG score: 0-2 points; 6. MSS/pMMR and BRAF wild type 7. Start time of chemotherapy is less than 2 months from the operation 8. Have sufficient organ functions; 9. The baseline blood routine and biochemical indexes of the subject meet the following standards: * hemoglobin ≥ 9.0 g / dl; * absolute neutrophil count (ANC) ≥ 1500 / mm3; * platelet count ≥ 100000 / mm3; * total bilirubin ≤ 1.5 times the upper limit of normal value (ULN); * glutamic pyruvic transaminase and glutamic oxalic transaminase ≤ 2.5 times ULN; * creatinine ≤ 1.5 times ULN; 10. Patients or family members who can understand the study protocol and are willing to participate in the study shall provide written informed consent. Exclusion Criteria: 1. Receive chemotherapy, radiotherapy or immunotherapy before operation 2. History of malignant tumor in the past 5 years (except fully cured cervical carcinoma in situ or basal cell carcinoma or squamous epithelial cell skin cancer) 3. Pregnant women 4. Serious mental illness 5. Those with poor physical condition and difficult to complete chemotherapy 6. Patients or family members cannot understand the conditions and objectives of this study
Where this trial is running
Beijing, Beijing Municipality
- Peking university cancer hospital — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Principal investigator: Aiwen Wu, M.D. — Peking University Cancer Hospital & Institute
- Study coordinator: Pengju Chen, M.D.
- Email: pengjuchen@163.com
- Phone: +8601088196086
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.