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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00630045
Other study ID # OXALIC
Secondary ID
Status Recruiting
Phase Phase 3
First received February 26, 2008
Last updated March 5, 2008
Start date January 2008
Est. completion date June 2015

Study information

Verified date February 2008
Source Peking University People's Hospital
Contact zhou jing, MD
Phone 86-10-66583821
Email zhoujing58@sohu.com
Is FDA regulated No
Health authority China: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 392
Est. completion date June 2015
Est. primary completion date June 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Drug:
neoadjuvant chemotherapy with oxaliplatin and capecitabine
oxaliplatin: 130mg/m2, d1(Q3w) capecitabine:1000mg/m2 bid, d1-14(Q3w)
Procedure:
resection of liver metastasis
surgery with the aim of R0 resection

Locations

Country Name City State
China Peking University, People's Hospital Beijing
China Peking University, School of Oncology Beijing Beijing

Sponsors (3)

Lead Sponsor Collaborator
Peking University People's Hospital Peking University, Sanofi

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary disease free survival rate 3 year No
Secondary R0 resection rate at the time of pathological report No
Secondary survival rate and over survival 5 year No
Secondary surgery related mortality peri-operation period Yes
Secondary response rate and safety of XELOX as a neoadjuvant regimen no time frame Yes
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