advanced colorectal cancer
Conditions
Interventions
test group:Maintain with capecitabine after XELOX or FOLFOX treatment
control group:XELOX or FOLFOX
Sponsors
West China Hospital,Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Having signed informed consent; 2. Aged 18 years old; 3. WHO performance status 0-2; 4. Histologically confirmed colorectal adenocarcinoma;Unresectable recurrent or metastatic disease;Measurable disease according to the RECIST criteria; 5. Disease evaluation with proven SD, PR or CR according to RECIST after 12-18 weeks induction first-line oxaliplatin-based chemotherapy(XELOX 4-6cycles or FOLFOX 6-9 cycles); 6. No prior radiotherapy except radiotherapy at non-target lesion of the study more than 4 weeks; 7. Laboratory values obtained 9g/dl, absolute neutrophil count > 1.5 x 10^9/L, platelets > 100 x 10^9/L), renal function (serum creatinine 30 ml/min), liver function (serum bilirubin =3 month.
Exclusion criteria
Exclusion criteria: 1. Metastatic colorectal cancer treated with more than one modality of first line chemotherapy (including oral fluoropyrimidines); 2. Tumour progression after first line chemotherapy or before randomization; 3. Symptomatic cerebral metastases; 4. Any severe uncontrolled disease in addition to colorectal cancer (in particular decompensated cardiac failure (LVEF<50%) or coronary insufficiency); 5. Lack of integrity of the upper GI tract: malabsorption syndrome or major surgery of the stomach or the small intestine; 6. Severe renal impairment (creatinine clearance < 30 ml/min); 7. Severe psychiatric disorder (other than controlled depressive syndrome); 8. Patient participating in another experiment; 9. Pregnant women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| OS;DCC;safety; | — |
Countries
China
Contacts
Public ContactBi Feng
Outcome results
None listed