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

Primary Purpose

Potentially Resectable Liver Metastasis From CRC, Colorectal Cancer

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Capecitabine plus oxaliplatin
Sponsored by
Guangdong Provincial People's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Potentially Resectable Liver Metastasis From CRC focused on measuring XELOX, potentially resectable liver metastasis from CRC

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Guangdong General Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Capecitabine plus oxaliplatin，mCRC

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

To investigate the response rate
To evaluate the R0 resection rate
To evaluate the safety profile of XELOX peri-operative treatment

Full Information

First Posted
October 18, 2009
Last Updated
October 18, 2009
Sponsor
Guangdong Provincial People's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00997685
Brief Title
Evaluate Efficacy and Safety of XELOX in Potentially Resectable Liver Metastasis From Colorectal Cancer(CRC)
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2009
Overall Recruitment Status
Unknown status
Study Start Date
November 2009 (undefined)
Primary Completion Date
October 2015 (Anticipated)
Study Completion Date
October 2015 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Guangdong Provincial People's Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Potentially Resectable Liver Metastasis From CRC, Colorectal Cancer
Keywords
XELOX, potentially resectable liver metastasis from CRC

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
110 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Capecitabine plus oxaliplatin，mCRC
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Capecitabine plus oxaliplatin
Other Intervention Name(s)
XELOX
Intervention Description
Xeloda: 1000mg/m2 bid, d1-14, q3w, Oxaliplatin:130mg/m2 d1, q3w, 4 pre-operative cycles, 4 post-operative cycles
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
To investigate the response rate
Time Frame
3.6 years
Title
To evaluate the R0 resection rate
Time Frame
3.6 years
Title
To evaluate the safety profile of XELOX peri-operative treatment
Time Frame
3.6 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Feng Lin, Dr
Phone
+8613903018609
First Name & Middle Initial & Last Name or Official Title & Degree
Yong Li, Dr
Phone
+8613822177479
Email
yongyongsmart@yahoo.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Feng Lin
Organizational Affiliation
Guangdong Provincial People's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Guangdong General Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yong Li, Dr
Email
yongyongsamrt@yahoo.cn
First Name & Middle Initial & Last Name & Degree
Feng Lin

12. IPD Sharing Statement

Learn more about this trial

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

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