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Trial Title:
Compare FOFLOX4 in Preoperative and Postoperative and Postoperative in Resectable Liver Metastasis Colorectal Cancer (MCC)
NCT ID:
NCT01035385
Condition:
Colorectal Cancer
Liver Metastasis
Conditions: Official terms:
Colorectal Neoplasms
Neoplasm Metastasis
Liver Neoplasms
Conditions: Keywords:
FOFLOX4
resectable liver metastasis from colorectal cancer
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Unknown status
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
FOFLOX4
Description:
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
Arm group label:
FOFLOX4,resectable liver metastasis from CRC
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.
Detailed description:
To investigate the three-year progression free survival (PFS) advantage of FOLFOX4 in the
treatment of resectable metastatic colorectal cancer.
Criteria for eligibility:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Guangdong General Hospital
Address:
City:
Guangzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Yong Li, Dr
Email:
yongyongsamrt@yahoo.cn
Investigator:
Last name:
Yong Li
Email:
Sub-Investigator
Start date:
September 2009
Completion date:
December 2015
Lead sponsor:
Agency:
Guangdong Provincial People's Hospital
Agency class:
Other
Source:
Guangdong Provincial People's Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01035385
