Postoperative Folfox4 Only Versus Folfox4 Plus Transhepatic Arterial Chemotherapy (TAC) in the Treatment Unresectable Liver Metastasis of Colorectal Cancer

Unresectable Liver Metastasis of Colorectal Cancer Clinical Trial

Official title:

Postoperative folfox4 Only vs folfox4 Plus TAC in the Treatment Unresectable Liver Metastasis of Colorectal Cancer: a Randomized,Prospective,Control Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00869271
• Other study ID #: 2009-01
• Status: Completed
• Phase: Phase 4
• First received: March 24, 2009
• Last updated: March 24, 2009
• Start date: January 2005
• Est. completion date: December 2007

Study information

• Verified date: March 2009
• Source: Fudan University
• Contact: n/a
• 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 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• 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 Neoplasms
• Liver Neoplasms
• Neoplasm Metastasis
• Unresectable Liver Metastasis of Colorectal Cancer

Intervention

Procedure:
• tac + folfox4
tac: oxaliplatin 100mg + fudr 1g + mmc 10mg folfox4 Folfox4 chemotherapy was done within 28 days after primary surgery. Per 3 weeks, patients will receive one cycle. After 3 cycles, patients will received transhepatic arterial chemotherapy(TAC) using oxaliplatin, fudr and mmc. Then begin folfox4 again.
• Folfox4
folfox4 Folfox4 chemotherapy was done within 28 days after primary surgery. Per 3 weeks, patients will receive one cycle

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 diagnosis	Yes
Secondary	progression free survival		5 years after diagonsis	Yes