Postoperative folfox4 Only vs folfox4 Plus TAC in the Treatment Unresectable Liver Metastasis of Colorectal Cancer: a Randomized,Prospective,Control Trial
18 Years
75 Years
Both
Unresectable Liver Metastasis of Colorectal Cancer
Trial Information
Postoperative folfox4 Only vs folfox4 Plus TAC in the Treatment Unresectable Liver Metastasis of Colorectal Cancer: a Randomized,Prospective,Control Trial
We administered three cycles FOLFOX4 plus on TAC (oxaliplatin, FUDR and MMC) or FOLFOX4 only
to primary colorectal tumor resected patients with unresected liver metastasis. The study
endpoints were resection rate of liver metastasis, progression-free survival, overall
survival as evaluated by intent-to-treat analysis.
Inclusion Criteria:
- age < 75 years with histologically proven adenocarcinoma of the colon or rectum
- no severe major organ dysfunction
- WHO performance status of 0 or 1
- no prior cancer therapy
- with measurable unresectableliver metastasis
- without other metastasis
Exclusion Criteria:
- age >= 75
- severe major organ dysfunction
- WHO performance status of >1
- prior cancer therapy
- with other metastasis
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
overall survival
Outcome Time Frame:
5 years after diagnosis
Safety Issue:
Yes
Principal Investigator
jianmin xu, MD, PHD
Investigator Role:
Study Director
Investigator Affiliation:
department of general surgery, zhongshan hospital, fudan university
Authority:
China: Ministry of Health
Study ID:
2009-01
NCT ID:
NCT00869271
Start Date:
January 2005
Completion Date:
December 2007
Related Keywords:
- Unresectable Liver Metastasis of Colorectal Cancer
- liver metastasis
- colorectal cancer
- Colorectal Neoplasms
- Neoplasm Metastasis
- Neoplasms, Second Primary
- Liver Neoplasms
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