CtDNA in Adjuvant Chemotherapy of Stage III Colon Cancer (REVISE Trial)

Launched by WEST CHINA HOSPITAL · Jan 27, 2024

Keywords

ClinConnect Summary

The REVISE trial is studying how a special test called circulating tumor DNA (ctDNA) can help doctors decide the best chemotherapy treatment for patients with stage III colon cancer after surgery. This trial is looking specifically at patients who have tested positive for ctDNA within a month after their surgery. Depending on the results of the ctDNA test, participants may receive different chemotherapy regimens, including a more intensive treatment called FOLFOXIRI or a standard treatment called XELOX. The goal is to find out if using ctDNA can help improve treatment outcomes and ensure patients receive the right level of chemotherapy.

To be eligible for this trial, participants must be between 18 and 75 years old and have had successful surgery for stage III colon cancer. They should not have had any other cancers recently, and they need to be in generally good health. Throughout the trial, participants can expect to receive multiple cycles of chemotherapy and blood tests to monitor their ctDNA levels. This study aims to improve how doctors tailor chemotherapy based on individual patient needs, potentially leading to better recovery and fewer side effects.

Gender

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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