Trial record 8 of 380 for: Open Studies | "Carcinoma, Hepatocellular"
Trial of Transcatheter Arterial Chemoembolization for Hepatocellular Carcinoma (ACE500)
This study is currently recruiting participants.
Verified October 2012 by Nihon University
Information provided by (Responsible Party):
Masashi Fujii, Nihon University
First received: February 12, 2009
Last updated: October 17, 2012
Last verified: October 2012
The purpose of this study is to compare the efficacy and safety of cisplatin (CDDP) and epirubicin (EPI) in the treatment of transcatheter chemoembolization for Hepatocellular Carcinoma (HCC).
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Randomized Controlled Trial of Transcatheter Arterial Chemoembolization for Hepatocellular Carcinoma|
Resource links provided by NLM:
Further study details as provided by Nihon University:
Primary Outcome Measures:
- response rate [ Time Frame: 6 months ] [ Designated as safety issue: No ]
|Study Start Date:||March 2009|
|Estimated Study Completion Date:||February 2015|
|Estimated Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
|Experimental: anti-cancer agent||
Arm E: Suspension is prepared before arterial infusion as follows: Epirubicin is dissolved with water-soluble, non-ionized contrast medium then mixed with Lipiodol by pumping. Then this suspension is administered by catheter as quick as possible, and gelatin is infused for arterial embolization. Maximum dose of EPI and Lipiodol are 60mg/m2 and 0.3mL/Kg, respectively.
Other Name: epi-adriamycinDrug: Cisplatin
Arm C: Suspension is prepared before arterial infusion as follows: Cisplatin (Water soluble CDDP: IA CALL) is mixed with Lipiodol. Then this suspension is administered by catheter as quick as possible, and gelatin is infused for arterial embolization. Maximum dose of Cisplatin and Lipiodol are 65mg/m2 and 0.3mL/Kg, respectively.
Other Name: CDDP
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00843934
|Contact: Masashi Fujii, MDemail@example.com|
|Contact: Tadatoshi Takayama, MD||+81339728111||Takayama.Tadatoshi@nihon-u.ac.jp|
|Department of Digestive Surgery, Nihon University School of Medicine||Recruiting|
|Itabashi, Tokyo, Japan, 173-8610|
|Contact: Masashi Fujii, MD +81332931711 ext 207 firstname.lastname@example.org|
|Contact: Tadatoshi Takayama, MD +81339728111 ext 2471 Takayama.Tadatoshi@nihon-u.ac.jp|
Sponsors and Collaborators
|Principal Investigator:||Tadatoshi Takayama, M.D.||Digestive Surgery Nihon University School of Medicine|