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Trial Title:
Phase 3 Study of Surgery Combined With Neoadjuvant Chemotherapy(XELOX) in Colorectal Cancer With Resectable Liver Metastasis
NCT ID:
NCT00630045
Condition:
Colorectal Cancer
Resectable Liver Metastasis
Conditions: Official terms:
Colorectal Neoplasms
Neoplasm Metastasis
Liver Neoplasms
Capecitabine
Oxaliplatin
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Unknown status
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
neoadjuvant chemotherapy with oxaliplatin and capecitabine
Description:
oxaliplatin: 130mg/m2, d1(Q3w) capecitabine:1000mg/m2 bid, d1-14(Q3w)
Arm group label:
1
Intervention type:
Procedure
Intervention name:
resection of liver metastasis
Description:
surgery with the aim of R0 resection
Arm group label:
1
Arm group label:
2
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Peking University, School of Oncology
Address:
City:
Beijing
Zip:
100036
Country:
China
Status:
Recruiting
Contact:
Last name:
Xiaotian Zhang, MD
Phone:
86-10-88196561
Email:
zhangxt@yahoo.com
Contact backup:
Last name:
jifang gong, MD
Phone:
86-10-88196088
Email:
goodjf@163.com
Facility:
Name:
Peking University, People's Hospital
Address:
City:
Beijing
Zip:
100044
Country:
China
Status:
Recruiting
Contact:
Last name:
jing zhou, MD
Phone:
86-10-66583821
Email:
zhoujing58@sohu.com
Start date:
January 2008
Completion date:
June 2015
Lead sponsor:
Agency:
Peking University People's Hospital
Agency class:
Other
Collaborator:
Agency:
Peking University
Agency class:
Other
Collaborator:
Agency:
Sanofi
Agency class:
Industry
Source:
Peking University People's Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT00630045
