Using ctDNA to improve chemotherapy for stage III 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 trial investigates the role of circulating tumor DNA (ctDNA) in guiding adjuvant chemotherapy for patients with stage III colon cancer. It aims to stratify patients based on their risk factors beyond traditional staging, potentially allowing for more personalized treatment plans. The study will involve administering chemotherapy regimens such as FOLFOXIRI and XELOX to eligible participants who have undergone radical surgery. By monitoring ctDNA levels, the trial seeks to assess the effectiveness of chemotherapy and improve patient outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age 18-75 years, regardless of gender.
2. Tumor located in the colon (the distance from the lower margin of the tumor to the anus is greater than 12 cm).
3. Radical surgery performed, with pathological stage III (T1-4N1-2M0) (AJCC TNM staging, 8th edition, 2017).
4. No local or distant tumor recurrence was found in imaging examination.
5. Eastern Cooperative Oncology Group (ECOG) performance status: 0-1.
6. adequate organ function: Hemoglobin ≥ 9 g/dL; WBC ≥ 3.5 × 109/ L; Neutrophils ≥ 1.5 × 109/L; Platelets ≥ 100 × 109/L; Creatinine clearance ≥ 50 mL/min (Cockcroft-Gault formula); ALT and AST ≤ 2.5 × ULN; Alkaline phosphatase ≤ 2.5 × ULN; Total bilirubin ≤ 1.5 × ULN.
7. No history of allergy to fluoropyrimidines or platinum-based drugs.
8. Voluntarily participating in this study, signing an informed consent form, good compliance, and cooperation with follow-up.

Exclusion Criteria:

1. History of other malignant tumors within the past five years (excluding basal cell carcinoma and/or cervical carcinoma in situ after radical surgery).
2. Patients with BRAF mutation status
3. Patients with microsatellite instability-high (MSI-H) or deficient mismatch repair (dMMR) status
4. Previous chemotherapy, radiotherapy, targeted therapy, immunotherapy, etc., for colon cancer.
5. Patients considering lynch syndrome.
6. Severe cardiovascular or cerebrovascular diseases, liver or kidney dysfunction, severe primary hematological diseases.
7. severe mental disorders
8. Any unstable condition or situation that may harm patient safety or compliance with the study, such as fertility needs, pregnancy, breastfeeding, depression, bipolar disorder, obsessive-compulsive disorder, or schizophrenia.
9. Recently participated in or currently participating in other clinical trials of drugs.
10. Patients deemed unsuitable for participation in this study by the investigator.

Withdrew Criteria

1. Severe adverse reactions to chemotherapy and being unable to continue chemotherapy
2. Metastatic or recurrence disease prior to randomization
3. Refusing further treatment at any time without reason

Where it's running

• The Affiliated Hospital of Guizhou Medical University
  Guiyang, Guizhou, China Recruiting
• West China Hospital of Sichuan University
  Chengde, Sichuan, China Recruiting
• People's Hospital of Sichuan Province
  Chengdu, Sichuan, China Recruiting
• Shang Jin Hospital of West China Hospital, Sichuan University
  Chengdu, Sichuan, China Recruiting
• Sichuan Cancer Hospital
  Chengdu, Sichuan, China Recruiting
• The Third People's Hospital of Chengdu
  Chengdu, Sichuan, China Recruiting

Study contacts

• Study coordinator: Ziqiang Wang
• Email: wangziqiang@scu.edu.cn
• Phone: +8685422480

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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.