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

Colorectal Cancer Clinical Trial

Official title:

A Phase III Study of Surgery in Combination With Neoadjuvant Chemotherapy of Oxaliplatin Plus Capecitabine in Colorectal Cancer With Respectable Liver Metastasis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00630045
• Other study ID #: OXALIC
• 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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Liver Neoplasms
• Neoplasm Metastasis
• Resectable Liver Metastasis

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