Randomized pahse III study evaluating the efficacy of hepatic arterial infusion chemotherapy for metastatic colorectal cancer patients with unresectable liver metastases

UMIN ID: UMIN000001491

Registered date:10/11/2008

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Colorectal cancer
• Date of first enrollment: 2008/11/01
• Target sample size: 150
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

In the tested group, after the radiological placement of port and catheter system, hepatic arterial infusion using 5FU is performed within 6 months at the longest, and then FOLFOX+Bevacizumab therapy is performed.
In the control group, FOLFOX+Bevacizumab therapy is performed.

Outcome(s)

• Primary Outcome: Overall survival period
• Secondary Outcome: Adverse events Time to treatment failure

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: 1)Massive pleural effusion or ascites 2)Bleeding of digestive organ 3)Uncontrolled active infection 4)Severe complications (ileus, interstitial pneumonia, uncontrolled-diabetis, cardiac failure, renal failure, liver cirrhosis, liver failure- 5)Active other malignancy 6)Phsicological disorder 7)Pregnancy or lactation 8)Positive HBs 9)Severe allergy to iodine contrast medium 10)Bone metastases requiring local treatment 11)Brain metastasis or suspiciou brain metastasis 12)Thrombosis or Embolism within 1 year 13)Grade 2 or more sensory disturbance (CTCAEv3.0) 14)Requiring anti-thrombogenic therapy to prevent thrombosis 15)Unsuitable by physician's decision

Related Information

• Primary Sponsor: Japan Interventional Radiology in Oncology Study Group (JIVROSG)
• Source(s) of Monetary Support: Japanese Society of Implantable Port Assisted Treatment