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TAC vs TACE Plus folfox4 as the Treatment of Unresectalbe Liver Metastasis of Colorectal Cancer With Resection of the Primary Tumor: a Prospective, Randomized, Control Trial


Phase 4
18 Years
75 Years
Open (Enrolling)
Both
Liver Metastasis, Colorectal Cancer

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Trial Information

TAC vs TACE Plus folfox4 as the Treatment of Unresectalbe Liver Metastasis of Colorectal Cancer With Resection of the Primary Tumor: a Prospective, Randomized, Control Trial


We administered three cycles FOLFOX4 plus TAC(oxaliplatin,FUDR and MMC) or FOLFOX4 plus
TACE(oxaliplatin,FUDR,MMC and embolision) 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 operation

Safety Issue:

No

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:

2009-03

NCT ID:

NCT00868569

Start Date:

January 2008

Completion Date:

December 2010

Related Keywords:

  • Liver Metastasis
  • Colorectal Cancer
  • liver metastasis
  • colorectal cancer
  • oxaliplatine
  • transartery chemotherapy
  • embolision
  • Unresectable Liver Metastasis of Colorectal Cancer
  • Colorectal Neoplasms
  • Neoplasm Metastasis
  • Neoplasms, Second Primary
  • Liver Neoplasms

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