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Phase 3 Study of Surgery Combined With Neoadjuvant Chemotherapy(XELOX) in Colorectal Cancer With Resectable Liver Metastasis
Conditions
Colorectal Cancer - Resectable Liver Metastasis
Conditions: official terms
Colorectal Neoplasms - Liver Neoplasms - Neoplasm Metastasis
Study Type
Interventional
Study Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: neoadjuvant chemotherapy with oxaliplatin and capecitabine
Type: Drug
Name: resection of liver metastasis
Type: Procedure
Overall Status
Recruiting
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
Healthy Volunteers: No
Maximum Age: 75 Years
Minimum Age: 18 Years
Gender: Both
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
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
Locations
Peking University, School of Oncology
Beijing, Beijing, China
Peking University, People's Hospital
Status: Recruiting
Contact: Xiaotian Zhang, MD - 86-10-88196561 - zhangxt@yahoo.com
Beijing, China
Status: Recruiting
Contact: jing zhou, MD - 86-10-66583821 - zhoujing58@sohu.com
Start Date
January 2008
Completion Date
June 2015
Sponsors
Peking University People's Hospital
Source
Peking University People's Hospital
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page