Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00997685
Recruitment Status : Unknown
Verified October 2009 by Guangdong General Hospital.
Recruitment status was:  Not yet recruiting
First Posted : October 19, 2009
Last Update Posted : October 19, 2009
Sponsor:
Information provided by:
Guangdong General Hospital

Tracking Information
First Submitted Date  ICMJE October 18, 2009
First Posted Date  ICMJE October 19, 2009
Last Update Posted Date October 19, 2009
Study Start Date  ICMJE November 2009
Estimated Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 18, 2009)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: October 18, 2009)
  • To investigate the response rate [ Time Frame: 3.6 years ]
  • To evaluate the R0 resection rate [ Time Frame: 3.6 years ]
  • To evaluate the safety profile of XELOX peri-operative treatment [ Time Frame: 3.6 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluate Efficacy and Safety of XELOX in Potentially Resectable Liver Metastasis From Colorectal Cancer(CRC)
Official Title  ICMJE 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
Brief 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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Potentially Resectable Liver Metastasis From CRC
  • Colorectal Cancer
Intervention  ICMJE 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 Name: XELOX
Study Arms  ICMJE Experimental: Capecitabine plus oxaliplatin,mCRC
Intervention: Drug: Capecitabine plus oxaliplatin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: October 18, 2009)
110
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2015
Estimated Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00997685
Other Study ID Numbers  ICMJE ML22298
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Institutions of national drug clinical trials, Guangdong General Hospital
Study Sponsor  ICMJE Guangdong General Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Feng Lin Guangdong General Hospital
PRS Account Guangdong General Hospital
Verification Date October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP