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

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ClinicalTrials.gov Identifier: NCT01035385
Recruitment Status : Unknown
Verified September 2009 by Guangdong General Hospital.
Recruitment status was:  Recruiting
First Posted : December 18, 2009
Last Update Posted : December 18, 2009
Sponsor:
Information provided by:
Guangdong General Hospital

Brief Summary:
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 or disease Intervention/treatment Phase
Colorectal Cancer Liver Metastasis Drug: FOFLOX4 Phase 3

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 340 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : September 2009
Estimated Primary Completion Date : October 2012
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. progression free survival (PFS) [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. response rate, incidence of postoperative complications,pathological response rate,R0 resection rate, 5-year overall survival,duration of disease control [ Time Frame: 5 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Feng Lin/Gastrointestinal Surgery, Guangdong General Hospital
ClinicalTrials.gov Identifier: NCT01035385     History of Changes
Other Study ID Numbers: VORP019
First Posted: December 18, 2009    Key Record Dates
Last Update Posted: December 18, 2009
Last Verified: September 2009

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