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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified October 2009 by Guangdong General Hospital
Sponsor:
Information provided by:
Guangdong General Hospital
ClinicalTrials.gov Identifier:
NCT00997685
First received: October 18, 2009
Last updated: NA
Last verified: October 2009
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Potentially Resectable Liver Metastasis From CRC
Colorectal Cancer
Drug: Capecitabine plus oxaliplatin
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Guangdong General Hospital:

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 [ Time Frame: 3.6 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To investigate the response rate [ Time Frame: 3.6 years ] [ Designated as safety issue: No ]
  • To evaluate the R0 resection rate [ Time Frame: 3.6 years ] [ Designated as safety issue: No ]
  • To evaluate the safety profile of XELOX peri-operative treatment [ Time Frame: 3.6 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 110
Study Start Date: November 2009
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: XELOX

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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00997685

Contacts
Contact: Feng Lin, Dr +8613903018609
Contact: Yong Li, Dr +8613822177479 yongyongsmart@yahoo.cn

Locations
China, Guangdong
Guangdong General Hospital Not yet recruiting
Guangzhou, Guangdong, China, 510080
Contact: Yong Li, Dr       yongyongsamrt@yahoo.cn   
Principal Investigator: Feng Lin         
Sponsors and Collaborators
Guangdong General Hospital
Investigators
Principal Investigator: Feng Lin Guangdong General Hospital
  More Information

No publications provided

Responsible Party: Institutions of national drug clinical trials, Guangdong General Hospital
ClinicalTrials.gov Identifier: NCT00997685     History of Changes
Other Study ID Numbers: ML22298
Study First Received: October 18, 2009
Last Updated: October 18, 2009
Health Authority: China: Ethics Committee

Keywords provided by Guangdong General Hospital:
XELOX
potentially resectable liver metastasis from CRC

Additional relevant MeSH terms:
Colorectal Neoplasms
Neoplasm Metastasis
Neoplasms, Second Primary
Liver Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neoplastic Processes
Pathologic Processes
Liver Diseases
Capecitabine
Oxaliplatin
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 18, 2014