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New treatment option for Colon Cancer
Official title CtDNA in Adjuvant Chemotherapy of Stage III Colon Cancer (REVISE Trial)
ClinicalTrials.gov ID: NCT06242418
What this study is testing
What is FOLFOXIRI?
FOLFOXIRI is an investigational medicine, being studied as a potential treatment for colon cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Colon cancer is one of the most common malignant tumors with an increasing incidence rate in China. Surgical resection is still the main treatment for colon cancer at present.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Age 18-75 years, regardless of gender.
- Tumor located in the colon (the distance from the lower margin of the tumor to the anus is greater than 12 cm).
- Radical surgery performed, with pathological stage III (T1-4N1-2M0) (AJCC TNM staging, 8th edition, 2017).
- No local or distant tumor recurrence was found in imaging examination.
- Eastern Cooperative Oncology Group (ECOG) performance status: 0-1.
You likely can't join if
- History of other malignant tumors within the past five years (excluding basal cell carcinoma and/or cervical carcinoma in situ after radical surgery).
- Patients with BRAF mutation status
- Patients with microsatellite instability-high (MSI-H) or deficient mismatch repair (dMMR) status
- Previous chemotherapy, radiotherapy, targeted therapy, immunotherapy, etc., for colon cancer.
- Patients considering lynch syndrome.
- Severe cardiovascular or cerebrovascular diseases, liver or kidney dysfunction, severe primary hematological diseases.
See the full eligibility criteria
- Age 18-75 years, regardless of gender.
- Tumor located in the colon (the distance from the lower margin of the tumor to the anus is greater than 12 cm).
- Radical surgery performed, with pathological stage III (T1-4N1-2M0) (AJCC TNM staging, 8th edition, 2017).
- No local or distant tumor recurrence was found in imaging examination.
- Eastern Cooperative Oncology Group (ECOG) performance status: 0-1.
- 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...
- No history of allergy to fluoropyrimidines or platinum-based drugs.
- Voluntarily participating in this study, signing an informed consent form, good compliance, and cooperation with follow-up.
- History of other malignant tumors within the past five years (excluding basal cell carcinoma and/or cervical carcinoma in situ after radical surgery).
- Patients with BRAF mutation status
- Patients with microsatellite instability-high (MSI-H) or deficient mismatch repair (dMMR) status
- Previous chemotherapy, radiotherapy, targeted therapy, immunotherapy, etc., for colon cancer.
- Patients considering lynch syndrome.
- Severe cardiovascular or cerebrovascular diseases, liver or kidney dysfunction, severe primary hematological diseases.
- severe mental disorders
- 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...
- Recently participated in or currently participating in other clinical trials of drugs.
- Patients deemed unsuitable for participation in this study by the investigator. Withdrew Criteria
- Severe adverse reactions to chemotherapy and being unable to continue chemotherapy
- Metastatic or recurrence disease prior to randomization
- Refusing further treatment at any time without reason
The study team makes the final eligibility decision.
Where it's taking place
- Guiyang, Guizhou, China
- Chengde, Sichuan, China
- Chengdu, Sichuan, China
- Kunming, Yunnan, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guiyang, Guizhou, China; Chengde, Sichuan, China; Chengdu, Sichuan, China; Kunming, Yunnan, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.