Using circulating tumor DNA to guide chemotherapy for colon cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.