Colorectal cancer
Conditions
Interventions
group with adjuvent chemotherapy:adjuvent chemotherapy
non-adjuvent chemotherapy:Observation and follow-up
Sponsors
Fudan University Shanghai Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 75 years old; 2. ECOG score =8g/dL, WBC >=3.5x10^9/L, neutrophils >=1.5x10^9/L, platelets >=100x10^9/L; (2) biochemical examination should meet the following criteria: creatinine and urea nitrogen <=1.0 ULN, ALT and AST <=2.5 ULN; 8. No history of allergy to 5-Fu and platinum; 9. Women of childbearing age must undergo a pregnancy test (serum or urine) and the results are negative 7 days before admission. Women should be willing to use appropriate methods of contraception during the trial and within 8 weeks after the last administration. Men should be agree to use appropriate methods of contraception during the trial or within 8 weeks after the last administration; 10. The subjects can understand the situation of this study and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1) patients with local recurrence of the anastomosis, including regional lymph node recurrence near the anastomosis. No matter whether the local recurrence is resected or not. 2) patients with bone, brain or peritoneal metastasis, although these patients may also have the chance of local destruction or resection, the prognosis of these patients is still very poor, and the destruction of metastatic foci is often only for the purpose of improving symptoms, so these patients need to be excluded. 3) patients received adjuvant chemotherapy containing oxaliplatin (such as CAPOX regimen or FOLFOX regimen) after colorectal tumor resection, and the metastatic lesions appeared during adjuvant chemotherapy or within 12 months after the end of the last adjuvant chemotherapy. These patients may not be suitable to receive adjuvant chemotherapy containing oxaliplatin after resection of metastatic tumors. 4) after the diagnosis of distant metastasis, the patients were treated with neoadjuvant chemotherapy containing oxaliplatin and the disease progressed (PD), even if the metastatic foci were resected and the patients reached a tumor-free state, still they were excluded from this study because of drug resistance to the chemotherapy regimen containing oxaliplatin. 5) if patients with distant metastasis are treated with multiple cycles of neoadjuvant chemotherapy, the number of postoperative adjuvant chemotherapy is too small, so it is difficult to analyze the value of postoperative adjuvant chemotherapy. Therefore, this study requires that the time of neoadjuvant chemotherapy before resection of metastatic focus should not be longer than 2 months. 6) patients who are allergic to 5-Fu or platinum. 7) there are serious digestive tract diseases that affect the absorption of oral chemotherapeutic drugs. 8) patients with other malignant tumors in the past or at the same time, except for cured basal cell carcinoma of the skin and carcinoma in situ of the cervix. 9) pregnant or lactating women. 10) patients with severe cardiovascular disease or diabetes who are not easy to control. 11) patients with mental disorders. 12) patients with severe infection. 13) patients who are unable or unwilling to comply with the research plan.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 3-year disease-free survival ; | — |
Secondary
| Measure | Time frame |
|---|---|
| 3-year overall survival; | — |
Countries
China
Contacts
Public ContactHongtu Zheng
Fudan University Shanghai Cancer Center
Outcome results
None listed