Trial of Transcatheter Arterial Chemoembolization for Hepatocellular Carcinoma (ACE500)
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|ClinicalTrials.gov Identifier: NCT00843934|
Recruitment Status : Unknown
Verified October 2012 by Masashi Fujii, Nihon University.
Recruitment status was: Recruiting
First Posted : February 13, 2009
Last Update Posted : October 19, 2012
|Condition or disease||Intervention/treatment||Phase|
|Carcinoma, Hepatocellular||Drug: epirubicin Drug: Cisplatin||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||450 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Randomized Controlled Trial of Transcatheter Arterial Chemoembolization for Hepatocellular Carcinoma|
|Study Start Date :||March 2009|
|Estimated Primary Completion Date :||December 2012|
|Estimated Study Completion Date :||February 2015|
|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-adriamycin
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
- response rate [ Time Frame: 6 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00843934
|Contact: Masashi Fujii, MDfirstname.lastname@example.org|
|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 email@example.com|
|Contact: Tadatoshi Takayama, MD +81339728111 ext 2471 Takayama.Tadatoshi@nihon-u.ac.jp|
|Principal Investigator:||Tadatoshi Takayama, M.D.||Digestive Surgery Nihon University School of Medicine|