Phase 3 Study of Surgery Combined With Neoadjuvant Chemotherapy(XELOX) in Colorectal Cancer With Resectable Liver Metastasis

• Status: Unknown status
• Trial end date: 2015-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This study aims to discuss the efficacy and safety of neoadjuvant chemotherapy with XELOX regimen (oxaliplatin plus capecitabine) .

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peking University People's Hospital
• Collaborators: Peking University; Sanofi
• Treatments: Capecitabine; Liver Extracts; Oxaliplatin

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