Evaluate Efficacy and Safety of XELOX in Potentially Resectable Liver Metastasis From Colorectal Cancer(CRC)

Colorectal Cancer Clinical Trial

Official title:

A Single Arm, Open-label Phase II Study to Evaluate the Efficacy and Safety of Capecitabine Plus Oxaliplatin (XELOX) in the Peri-operative Treatment of Patients With Potentially Resectable Liver Metastasis From Colorectal Cancer

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00997685
• Other study ID #: ML22298
• Status: Not yet recruiting
• Phase: Phase 2
• First received: October 18, 2009
• Last updated: October 18, 2009
• Start date: November 2009
• Est. completion date: October 2015

Study information

• Verified date: October 2009
• Source: Guangdong General Hospital
• Contact: Feng Lin, Dr
• Phone: +8613903018609
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

This is a single arm, open-label phase II study to evaluate the efficacy and safety of Capecitabine plus oxaliplatin (XELOX) in the peri-operative treatment of patients with potentially resectable liver metastasis from colorectal cancer.

Description:

To investigate the progression free survival (PFS) advantage of Xeloda plus oxaliplatin in the peri-operative treatment of potential resectable metastatic colorectal cancer

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 110
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Age of 18 and 65

• Histologically confirmed colorectal cancer and two methords of imaging detection confirmed liver metastasis

• Potentially curable by resection, as determined by a surgeon with hepatic surgery expertise

• No evidence of extrahepatic disease by chest x-ray or CT scan of the chest, abdomen, and pelvis

• Patients with adequate hepative, renal and bone marrow function

• Signed written informed consent

Exclusion Criteria:

• Pregnant or nursing patients (fertile patients must use effective contraception)

• Other malignancy within the past 5 years except completely resected nonmelanoma skin cancer or carcinoma in situ of the cervix

• Preexisting grade 2 or greater peripheral neuropathy

• Concurrent uncontrolled illness

• Ongoing or active infection

• Psychiatric illness or social situation that would preclude study compliance

• Less than 6 months since prior adjuvant fluorouracil-based chemotherapy

• Prior chemotherapy for liver metastasis

• Prior oxaliplatin for colorectal cancer

• Prior or concurrent hepatic artery infusion chemotherapy for metastatic disease

• Prior or concurrent radiotherapy for metastatic disease

• Prior or concurrent radiofrequency ablation for metastatic disease

• concurrent treatment with any other anti-cancer therapy.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Liver Neoplasms
• Neoplasm Metastasis
• Potentially Resectable Liver Metastasis From CRC

Intervention

Drug:
• Capecitabine plus oxaliplatin
Xeloda: 1000mg/m2 bid, d1-14, q3w, Oxaliplatin:130mg/m2 d1, q3w, 4 pre-operative cycles, 4 post-operative cycles

Locations

Country	Name	City	State
China	Guangdong General Hospital	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Guangdong General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To investigate the progression free survival (PFS) advantage of Xeloda plus oxaliplatin in the peri-operative treatment of potential resectable metastatic colorectal cancer		3.6 years	No
Secondary	To investigate the response rate		3.6 years	No
Secondary	To evaluate the R0 resection rate		3.6 years	No
Secondary	To evaluate the safety profile of XELOX peri-operative treatment		3.6 years	No