Transhepatic Arterial Chemotherapy (TAC) Versus Transcatheter Arterial Chemoembolization (TACE) Plus Folfox4 as the Treatment of Unresectable Liver Metastasis of Colorectal Cancer

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00868569
• Other study ID #: 2009-03
• Status: Recruiting
• Phase: Phase 4
• First received: March 24, 2009
• Last updated: March 24, 2009
• Start date: January 2008
• Est. completion date: December 2010

Study information

• Verified date: March 2009
• Source: Fudan University
• Contact: jianmin xu, MD, PHD
• Phone: 008613501984869
• Email: xujmin[@]yahoo.com.cn
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to investigate whether TAC plus FOLFOX4 or TACE plus folfox4 are able to improve resection rate and overall survival in patients receiving primary colorectal tumor resection than given FOLFOX4 only.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Liver Metastasis
• Liver Neoplasms
• Neoplasm Metastasis

Intervention

Procedure:
• TACE + folfox 4
tace: oxaliplatin 100mg + fudr 1g + mmc 10mg + iodine 2ml folfox4
• TAC + folfox4
tac: oxaliplatin 100mg + fudr 1g + mmc 10mg folfox4

Locations

Country	Name	City	State
China	Zhongshan Hospital, Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall survival		5 years after operation	No
Secondary	resection rate of liver metastasis progression-free survival		5 years after operation	Yes