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Compare FOFLOX4 in Preoperative and Postoperative and Postoperative in Resectable Liver Metastasis Colorectal Cancer (MCC)

This study is currently recruiting participants.
Verified September 2009 by Guangdong General Hospital
Sponsor:
Information provided by:
Guangdong General Hospital
ClinicalTrials.gov Identifier:
NCT01035385
First received: December 16, 2009
Last updated: December 17, 2009
Last verified: September 2009
History of Changes
  Purpose

This study is a multicenter, open-label, randomized ,controlled phase III study to compare preoperative and postoperative with FOFLOX4 chemotherapy and postoperative with FOFLOX4 chemotherapy in patients with resectable liver metastasis from colorectal cancer.


Condition Intervention Phase
Colorectal Cancer
Liver Metastasis
 Drug: FOFLOX4
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase III Study to Compared Preoperative and Postoperative With FOFLOX4 Chemotherapy and Postoperative With FOFLOX4 Chemotherapy in Patients With Resectable Liver Metastasis From Colorectal Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Guangdong General Hospital:

Primary Outcome Measures:
  • progression free survival (PFS) [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • response rate, incidence of postoperative complications,pathological response rate,R0 resection rate, 5-year overall survival,duration of disease control [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 340
Study Start Date: September 2009
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: FOFLOX4,resectable liver metastasis from CRC Drug: FOFLOX4
FOLFOX4:Oxaliplatin 85mg/m2 ivgtt d1 2hr calcium leucovorin:200mg/m2 ivgtt d1 d2 2hr fluorouracil:400mg/m2 iv d1 d2 fluorouracil:600mg/m2 civ d1 d2 22hr 2 weeks repeated one cycles

Detailed Description:

To investigate the three-year progression free survival (PFS) advantage of FOLFOX4 in the treatment of resectable metastatic colorectal cancer.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Resectable liver metastasis from colorectal cancer(the distance from the tumor lower edge to anal more than 12cm),no visible extrahepatic metastatic tumors. Curable by resection, as determined by a surgeon and imaging physicians. The minimum of the liver metastases needs ≥2cm. Patients can be recruited if meet the conditions about:

    • Primary tumor had been removed of the metachronous liver metastasis patients and no residue from the eyes or microscope.
    • Primary tumor has been removed more than 1 month of the simultaneous liver metastasis patients.
  2. Age of≥18 and ≤80
  3. ECOG≤2
  4. Signed written informed consent

Exclusion Criteria:

  1. Peripheral neuropathy(CTC＞1)
  2. Had a neurological or mental disorders
  3. Active infection
  4. Allergy to Platinum-based and other drugs
  5. Other acute diseases including infection, heart-disease(CHF, stable or unstable angina)
  6. Pregnant or nursing patients
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01035385

Contacts
Contact: Feng Lin, Dr 86-20-83827812-60910

Locations
China, Guangdong
Guangdong General Hospital Recruiting
Guangzhou, Guangdong, China
Contact: Yong Li, Dr         yongyongsamrt@yahoo.cn    
Sub-Investigator: Yong Li            
Sponsors and Collaborators
Guangdong General Hospital
Investigators
Principal Investigator: Feng Lin, Dr Guangdong General Hospital
  More Information

No publications provided

Responsible Party: Feng Lin/Gastrointestinal Surgery, Guangdong General Hospital
ClinicalTrials.gov Identifier: NCT01035385     History of Changes
Other Study ID Numbers: VORP019
Study First Received: December 16, 2009
Last Updated: December 17, 2009
Health Authority: China: Ethics Committee

Keywords provided by Guangdong General Hospital:
FOFLOX4
resectable liver metastasis from colorectal cancer

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

ClinicalTrials.gov processed this record on June 18, 2013