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

Phase 3

• Conditions: Colorectal Cancer; Resectable Liver Metastasis
• Interventions: Drug: neoadjuvant chemotherapy with oxaliplatin and capecitabine; Procedure: resection of liver metastasis

• Registration Number: NCT00630045
• Lead Sponsor: Peking University People's Hospital

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.

Study Timeline

• Study Start: 2008-01
• Status Verified: 2008-02
• Study First Submitted: 2008-02-26
• Study First Submitted QC: 2008-03-05
• Last Update Submitted: 2008-03-05
• Study First Posted: 2008-03-06
• Last Update Posted: 2008-03-06
• Primary Completion: 2010-06
• Study Completion: 2015-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 392

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	resection of liver metastasis	2\~3 cycles of neoadjuvant chemotherapy before resection of liver metastasis
2	resection of liver metastasis	no neoadjuvant chemotherapy, resect the liver metastasis directly
1	neoadjuvant chemotherapy with oxaliplatin and capecitabine	2\~3 cycles of neoadjuvant chemotherapy before resection of liver metastasis

Primary Outcome Measures

Name	Time	Method
disease free survival rate	3 year

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Peking University, School of Oncology; 🇨🇳 Beijing, Beijing, China

Peking University, People's Hospital; 🇨🇳 Beijing, China