colorectal cancer
Conditions
Interventions
Capecitabine monotherapy group:Capecitabine monotherapy ×8 courses (Capecitabine monotherapy: capecitabine 1250mg/m2 orally once in the morning and once in the evening, on days 1-14, repeated every 3
CapOx chemotherapy group:CapOx regimen × 8 courses (CapOx regimen: oxaliplatin 130mg/m2 intravenous infusion for 2 hours, day 1
Capecitabine 1250mg/m2 is taken orally once in the morning and once in the evening, on days 1-14, and repeated every 3 weeks.
Sponsors
Affiliated Hospital of Guangdong Medical University
Eligibility
Sex/Gender
All
Age
65 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Before performing any procedures related to the study protocol other than routine care, a voluntary signed and dated informed consent must be obtained from the subject in accordance with regulations and institutional guidelines. 2. Age 65-85. 3. Confirmed histological evidence of colorectal adenocarcinoma. 4.ECOG physical status score is 0-1. 5. TNM staging was performed by spiral or multi-slice CT to confirm that there was no distant metastasis. 6. Did not receive any treatment before surgery (including chemoradiotherapy, molecular targeted therapy and immunotherapy). 7. The patient underwent radical surgery (R0) resection, and the postoperative pathological stage was high-risk stage II or III. 8. Randomization must be within 8 weeks after surgery. 9. Appropriate organ function based on the following laboratory test values obtained within 7 days prior to treatment: Hemoglobin =90g/L, neutrophil count =1.5×109/L, platelet count =75×109/L. Serum total bilirubin =1.5× upper limit of normal (UNL), aspartate transferase =2×UNL. Alanine transferase =3×UNL, serum creatinine =1.5×UNL. 10. Willing and able to follow research procedures and visit plans.
Exclusion criteria
Exclusion criteria: 1) Whole-body CT, MR Or PET-CT (including at least the whole abdomen and pelvis of the chest) confirms distant metastases (M1). 2) Patients with postoperative obstruction or active bleeding. 3) Other active malignancies are present in the past or at the same time (except malignancies that have been treated with curative therapy and have been free of disease for more than 5 years or cancers in situ that can be cured with adequate treatment). 4) The time between the operation and the start of adjuvant therapy has exceeded 8 weeks. 5) Patients receiving neoadjuvant therapy. 6) Active coronary artery disease, severe/unstable angina pectoris or newly diagnosed angina pectoris or myocardial infarction in the 12 months prior to study participation. 7) Thrombotic or embolic events occurred within the past 6 months, such as cerebrovascular accidents (including transient ischemic attacks), pulmonary embolism, and deep vein thrombosis. 8) New York Heart Society (NYHA) Grade II or above congestive heart failure. 9) There are known diseases associated with human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS). 10) The presence of active inflammatory bowel disease or other colorectal disease that causes chronic diarrhea. 11) A known or suspected history of allergy to any of the relevant drugs used in the study. 12) Pregnant or lactating women. 13) Women of reproductive age who do not use or refuse to use effective non-hormonal contraception (< 2 years after the last menstrual period) or men who are likely to have children. 14) Any medical condition that is unstable or could affect patient safety and their compliance with the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 3-year disease-free survival rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| 3-year overall survival rate;3-year local recurrence-free survival rate;Survival time without distant metastasis;Safety;Quality of life; | — |
Countries
China
Contacts
Public ContactZhou Caijin
Affiliated Hospital of Guangdong Medical University
Outcome results
None listed