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

October 18, 2009 updated by: Guangdong Provincial People's Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Anticipated)

110

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510080
        • Guangdong General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Capecitabine plus oxaliplatin，mCRC
Drug: Capecitabine plus oxaliplatin

Xeloda: 1000mg/m2 bid, d1-14, q3w, Oxaliplatin:130mg/m2 d1, q3w,

4 pre-operative cycles, 4 post-operative cycles

Other Names:
  • XELOX

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To investigate the progression free survival (PFS) advantage of Xeloda plus oxaliplatin in the peri-operative treatment of potential resectable metastatic colorectal cancer
Time Frame: 3.6 years
3.6 years

Secondary Outcome Measures

Outcome Measure
Time Frame
To investigate the response rate
Time Frame: 3.6 years
3.6 years
To evaluate the R0 resection rate
Time Frame: 3.6 years
3.6 years
To evaluate the safety profile of XELOX peri-operative treatment
Time Frame: 3.6 years
3.6 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guangdong Provincial People's Hospital

Investigators

  • Principal Investigator: Feng Lin, Guangdong Provincial People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (Anticipated)

October 1, 2015

Study Completion (Anticipated)

October 1, 2015

Study Registration Dates

First Submitted

October 18, 2009

First Submitted That Met QC Criteria

October 18, 2009

First Posted (Estimate)

October 19, 2009

Study Record Updates

Last Update Posted (Estimate)

October 19, 2009

Last Update Submitted That Met QC Criteria

October 18, 2009

Last Verified

October 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML22298

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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