Using ctDNA to improve chemotherapy for stage III colon cancer

Value of CtDNA in Surveillance of Adjuvant Chemosensitivity and Regimen Adjustment in Stage III Colon Cancer: a Phase II Randomized Controlled Trial (REVISE Trial)

This study is testing whether using blood tests to check for tumor DNA can help doctors give better chemotherapy to people with stage III colon cancer after surgery.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: West China Hospital (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 9 sites (Guiyang, Guizhou and 8 other locations)
• Trial ID: NCT06242418 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 with stage III colon cancer who have undergone radical surgery and meet specific health criteria.

Not a fit: Patients with a history of other malignant tumors within the past five years may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to more tailored chemotherapy regimens, improving survival rates and reducing unnecessary treatment for low-risk patients.

How similar studies have performed: Previous studies have shown promise in using ctDNA for monitoring cancer treatment, suggesting this approach could be beneficial.

Eligibility criteria

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 this trial is running

Guiyang, Guizhou and 8 other locations

• 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)
• West China Tianfu Hospital, Sichuan University — Chengdu, Sichuan, China (Recruiting)
• First Affiliated Hospital of Kunming Medical University — Kunming, Yunnan, China (Recruiting)
• Yunnan Cancer Hospital — Kunming, Yunnan, China (Recruiting)

Study contacts

• Study coordinator: Ziqiang Wang

Conditions Colon Cancer; colon cancer; ctDNA; adjuvant chemotherapy