ePRO for Adjuvant Therapy of Colorectal Adenocarcinoma

This is an interventional health services research trial for Colorectal Carcinoma focused on measuring electronic patient reported outcomes, colorectal carcinoma, adjuvant chemotherapy, quality of life Read More

Inclusion Criteria:

1. 18 to 75 years old (inclusive), regardless of gender.
2. Patients with colorectal cancer diagnosed by cytology or histopathology.
3. The patient underwent radical surgery for cancer. Radical surgery is defined as routine laparotomy or laparoscopic radical surgery for the purpose of radical
4. The ECOG performance status is 0 to 2 points and able to receive adjuvant chemotherapy.
5. Patients must be randomized within 2 months after the surgery.
6. According to the investigator's judgment, the patient has recovered from surgical side effects after radical surgery (e.g., the wound has healed fully without complications).
7. Oxaliplatin regimen is planned to be used for postoperative adjuvant chemotherapy for 3 to 6 months
8. The blood pregnancy test results of women of childbearing age must be negative within 7 days prior to randomization.

9. The main organs function well. That is, the relevant inspection indexes within 14 days prior to enrollment meet the following requirements:

   a) Routine blood test: i. Leukocyte≥ 4.0×109/L; ii. Neutrophil count > 1.5×109/L; iii. Blood platelet count > 80×109/L; iv. Hemoglobin > 90 g/L (No blood transfusion in 14 days); b) Biochemistry test: i. TBil ≤ 1.5×ULN (upper limit of normal); ii. Blood glutamic alanine aminotransferas (ALT) or serum aspartate aminotransferase (AST) ≤ 2.5×ULN; iii. Endogenous creatinine clearance rate ≥ 60 ml/min (Cockcroft-Gault formula); c) Cardiac doppler ultrasound evaluation: left ventricular ejection fraction (LVEF) ≥ 50%.

10. The patient has provided written informed consent prior to any study-specific procedures, and is willing and able to be present during the study and follow the study procedure during treatment and follow-up.

Exclusion Criteria:

1. <18 years old or >75 years old.
2. Other tumors except gastric and colorectal cancer.
3. Metastasis has occurred.
4. Female during pregnancy or lactation.
5. A history of other malignant tumors within 5 years, except for adequately treated basal cell carcinoma or squamous cell carcinoma or carcinoma in situ.
6. The patient is known to be allergic to oxaliplatin, 5-FU, folinic acid or any excipients of these products.

7. Evidence of any severe or uncontrolled systemic disease, including but not limited to:

   1. Unstable or decompensated respiratory, cardiac, liver or kidney disease;
   2. HIV infection;
   3. Uncontrol high blood pressure, diabetes;
   4. Severe arrhythmia;
   5. Massive active bleeding.
8. A history of alcohol abuse or drug abuse.
9. As judged by the investigator, there is a low likelihood of enrollment (including inability to understand study requirements, poor compliance, infirmity, inability to ensure that the protocol can be followed as required, etc.), or there are other factors considered by the investigator to be unsuitable for this study.