Colorectal Cancer, Resectable Liver Metastasis
Conditions
Brief summary
This study aims to discuss the efficacy and safety of neoadjuvant chemotherapy with XELOX regimen (oxaliplatin plus capecitabine) .
Detailed description
Liver metastasis is the most important prognostic factor of colorectal cancer. Reasonable multidisciplinary therapy might improve the prognosis of patients with liver metastasis. Surgery has been the first choice under such situation. Recently, neoadjuvant chemotherapy has also shown its value in unresectable liver metastasis, for it can increase the chance of R0 resection and give some clues to chemosensitivity of agents. However, for those resectable lesions, the role and safety of neoadjuvant chemotherapy has yet to be confirmed. so we design this study.
Interventions
DRUGneoadjuvant chemotherapy with oxaliplatin and capecitabine
oxaliplatin: 130mg/m2, d1(Q3w) capecitabine:1000mg/m2 bid, d1-14(Q3w)
PROCEDUREresection of liver metastasis
surgery with the aim of R0 resection
Sponsors
Peking University
Sanofi
Peking University People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Histologically confirmed colorectal cancer with liver metastasis(all patients should have the pathological report of colorectal cancer. The chances of hepatocellular carcinoma or metastasis from other primary lesions should be excluded. ) 2. Liver metastasis should be resected with R0 resection and to save enough normal liver tissue 3. Anticipated liver resection: for normal liver, ﹤70%; for liver with cirrhosis, ﹤50% 4. No metastasis of other organs or lymph nodes in abdominal cavity 5. No previous use of oxaliplatin and capecitabine, or previous adjuvant treatment ended more than 6 months 6. Age 18 to 75 years old 7. Karnofsky performance status ≥70 8. Life expectancy of ≥3 month 9. Bilirubin level \< 1.5mg/dL 10. Serum creatinine \<1.0 times ULN 11. Absolute neutrophil count ≥2000/mm3, platelet\>100,000/mm3, Hb\>9g/dl 12. Having signed informed consent
Exclusion criteria
1. previous use of oxaliplatin or fluorouracil-based chemotherapy in 6 months. 2. No R0 resection or not enough normal liver tissue left 3. previous radiotherapy of target lesions 4. accompanied with unresectable other metastasis or malignant pleural fluids or ascites. 5. complete or uncompleted liver obstruction 6. peripheral neuropathy(NCI-CTC grade 1 or more) 7. mental disturbance neuropathy that influence the cognition, including brain metastasis 8. other serious disease such as uncontrollable active infection, heart infarction with 1 year, un controlled hypertension, arrhythmia with high risk, or unstable heart infarction,heart failure, coronary artery disease, myocardial infarction within the last 6 months 9. Other previous malignancy within 5 year, except non-melanoma skin cancer 10. accompany with other anti-tumor therapies,including immune therapy, intervention or injection with chemotherapeutical agents into serous cavity, or participating other clinical trials. 11. Pregnancy or lactation period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| disease free survival rate | 3 year |
Secondary
| Measure | Time frame |
|---|---|
| R0 resection rate | at the time of pathological report |
| survival rate and over survival | 5 year |
| surgery related mortality | peri-operation period |
| response rate and safety of XELOX as a neoadjuvant regimen | no time frame |
Countries
China
Contacts
Primary Contactzhou jing, MD
Backup ContactXiaotian Zhang, MD
Outcome results
None listed