Colorectal Cancer
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Patients must meet all of the following criteria to be enrolled in this study: 1. Age >= 18 years; 2. Histologically confirmed high-risk stage II or stage III colorectal cancer; 3. Underwent radical resection within 12 weeks prior to the first visit; 4. No prior adjuvant chemotherapy; 5. Eastern Cooperative Oncology Group (ECOG) performance status score of 0–2; 6. Adequate bone marrow, liver, and kidney function, defined as follows: (1) Bone marrow function: absolute neutrophil count >= 1.5 × 10?/L, hemoglobin >= 90 g/L, platelet count >= 100 × 10?/L; (2) Liver function: serum total bilirubin = 50 mL/min, and urine dipstick protein < 1+ (unless 24-hour urine protein quantification < 1 g). 7. Capable of understanding the study procedures and willing to provide written informed consent voluntarily.
Exclusion criteria
Exclusion criteria: Patients meeting any of the following criteria will be excluded from this study: 1. History of other primary malignant tumors; 2. Previous neoadjuvant radiotherapy or chemotherapy for the current diagnosis; 3. History of psychiatric disorders; 4. Currently pregnant; 5. Currently participating in another interventional clinical trial that may interfere with the evaluation of the primary outcome of this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Serum 25-hydroxyvitamin D (25(OH)D) level;Serum C-reactive protein (CRP) level; | — |
Countries
China
Contacts
Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China