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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. (see Contacts and Locations)
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

December 16, 2009
December 17, 2009
September 2009
October 2012   (final data collection date for primary outcome measure)
progression free survival (PFS) [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01035385 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Compare FOFLOX4 in Preoperative and Postoperative and Postoperative in Resectable Liver Metastasis Colorectal Cancer (MCC)
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

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.

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

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Colorectal Cancer
  • Liver Metastasis
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
Experimental: FOFLOX4,resectable liver metastasis from CRC
Intervention: Drug: FOFLOX4
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
340
December 2015
October 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact: Feng Lin, Dr 86-20-83827812-60910
China
 
NCT01035385
VORP019
No
Feng Lin/Gastrointestinal Surgery, Guangdong General Hospital
Guangdong General Hospital
Not Provided
Principal Investigator: Feng Lin, Dr Guangdong General Hospital
Guangdong General Hospital
September 2009

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