Colorectal Cancer, Liver Metastasis
Conditions
Keywords
Colorectal Cancer, liver metastasis, neoadjuvant chemotherapy
Brief summary
This study is a multicenter ,randomization, open control study to evaluate the efficacy and safety of Raltitrexed-based chemotherapy and 5-fluorouracil-based chemotherapy in the peri-operative treatment of patients with Liver Metastasis From colorectal cancer (CRC).
Detailed description
The contrast analysis is separately done on Raltitrexed plus oxaliplatin and 5-fluorouracil plus oxaliplatin;Raltitrexed plus irinotecan and 5-fluorouracil plus irinotecan.To investigate the objective response rate,the R0 resection rate, the early tumor shrinkage （ETS）and depth of response(DPR) and the safety profile.
Interventions
DRUGRaltitrexed-based chemotherapy
Raltitrexed: 2.0mg,iv,15min,d1,Oxaliplatin:85mg/m2 iv,d1, q2w
DRUG5-fluorouracil-based chemotherapy
5-fluorouracil:400mg/m2,ivp,2h,d1,1200mg/m2/d\*2d(2400mg/m2,iv46-48h); Oxaliplatin:85mg/m2 iv,d1,q2w
Sponsors
Zhejiang University
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 chinese colorectal cancer patients and imaging detection confirmed liver metastasis 2. previously no treatment for liver metastasis or Primary tumor had been removed and last additional chemotherapy over one year 3. Age of≥18 and ≤75 4. Adequate organ functions, as determined by normal bone marrow function (absolute neutrophil count2 x 109/L, platelets 100 x 109/L, White blood cells 4 x 109/L), liver function (serum bilirubin ≤ 2.5 x ULN, serum transaminases ≤2. 5x ULN) 5. ECOG≤1 6. Life Expectancy\>6months 7. Signed written informed consent 8. Expected adequacy of follow-up
Exclusion criteria
1. Lesion is too small to assess by imaging 2. Extrahepatic metastases 3. Any anticancer chemotherapy in development within 4 weeks prior to study entry 4. Concurrent uncontrolled illness such as infection 5. Be allergic to medicines in the study 6. Pregnant or nursing patients 7. Fertile women (\< 2 years after last menstruation) and men of childbearing potential not willing to use effective means of contraception. 8. Not willing or incapable to comply with all study visits and assessments 9. Evidence of any other disease, metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that puts the patient at high risk for treatment-related complications.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate | 38 months |
Secondary
| Measure | Time frame |
|---|---|
| R0 resection rate of liver | 38 months |
Other
| Measure | Time frame |
|---|---|
| The side effects of the treatment | 38 months |
| The early tumor shrinkage （ETS）and depth of response(DPR) | 38 months |
Countries
China
Outcome results
None listed