Preoperative Transhepatic Arterial Chemotherapy (TAC) in the Treatment of Liver Metastasis of Resectable Colorectal Cancer

• ClinicalTrials.gov Identifier: NCT00874406
• Recruitment Status: Unknown
• First Posted: April 2, 2009
• Last Update Posted: April 2, 2009
• Sponsor: Fudan University
• Information provided by: Fudan University

Tracking Information

• First Submitted Date: April 1, 2009
• First Posted Date: April 2, 2009
• Last Update Posted Date: April 2, 2009
• Study Start Date: January 2008
• Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: April 1, 2009): progression free survival [ Time Frame: 5 years after operation ]
• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted
• Current Secondary Outcome Measures (submitted: April 1, 2009): overall survival [ Time Frame: 5 years after operation ]
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Preoperative Transhepatic Arterial Chemotherapy (TAC) in the Treatment of Liver Metastasis of Resectable Colorectal Cancer
• Official Title: Preoperative Transhepatic Arterial Chemotherapy in the Treatment of Liver Metastasis of Resectable Colorectal Cancer
• Brief Summary: The purpose of this study is to investigate whether preoperative TAC is able to improve progression free survival and overall survival in patients receiving liver metastasis resection of colorectal cancer.
• Detailed Description: We administered TAC(oxaliplatin,FUDR and MMC) 7 days before liver metastasis resection of colorectal cancer. The study endpoints were progression free survival and overall survival as evaluated by intent-to-treat analysis.
• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Colorectal Cancer

Intervention

• Drug: tac + folfox4
  tac: oxaliplatin 100mg + fudr 1g + mmc 10mg 7 days later： operation within 28 days after operation: folfox4
• Drug: folfox4
  folfox4 will be done within 28 days after liver resection

Study Arms

• Experimental: 1
  transhepatic arterial chemotherapy (TAC) were given 7 days before liver metastasis resection. Adjuvant folfox4 chemotherapy was done within 28 days after surgery.
  Intervention: Drug: tac + folfox4
• Active Comparator: 2
  Liver metastasis resection was done without TAC. Adjuvant folfox4 chemotherapy was done within 28 days after surgery.
  Intervention: Drug: folfox4

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: April 1, 2009): 100
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 2009
• Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• age <= 75 years
• resectable liver metastasis
• remnant liver volume >= 70%
• without other organ metastasis or peritoneum metastasis
• without contradiction of cardiac and pulmonary diseases

Exclusion Criteria:

• age > 75 years
• unresectable liver metastasis
• remnant liver volume < 50%
• with other organ metastasis or peritoneum metastasis
• with contradiction of cardiac and pulmonary diseases

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: China

Administrative Information

• NCT Number: NCT00874406
• Other Study ID Numbers: 2009-04
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Xujianmin, Zhongshan hospital, Fudan University
• Study Sponsor: Fudan University
• Collaborators: Not Provided

Investigators

• Principal Investigator: jianmin xu, MD, PHD; department of general surgery, zhongshan hospital, fudan university

• PRS Account: Fudan University
• Verification Date: April 2009