UMIN ID: C000000111
Registered date:04/09/2005
Transarterial infusion chemotherapy using SMANCS with or without embolization in hepatocellular carcinoma: a randomised controlled multicenter phase III trial
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | hepatocellular carcinoma |
| Date of first enrollment | 1999/10/01 |
| Target sample size | 160 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | transcatheter arterial chemoembolization Transarterial infusion chemotherapy |
Outcome(s)
| Primary Outcome | survival |
|---|---|
| Secondary Outcome |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | 75years-old |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | Patients were excluded if they met the following criteria: extrahepatic metastasis or tumor thrombus in the portal vein and/or the hepatic vein, refractory pleural or peritoneal effusion, a history of allergy to iodine-containing agent and/or contrast material, a history of acute myocardial infarction in preceding 3 months, serious mental disorder, concomitant malignancy, pregnant or lactating women and patients of reproductive potential, intrahepatic arteriovenous shunting, or other serious medical conditions. |
Related Information
| Primary Sponsor | Research group for randomised study comparing transcatheter arterial chemoembolization to transarterial infusion chemotherapy |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | the Ministry of Health, Labour and Welfare of Japan |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Takuji Okusaka |
| Address | 5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan Japan |
| Telephone | 03-3542-2511 |
| Affiliation | National Cancer Center Hospital Hepatobiliary and Pancreatic Oncology Division |
| scientific contact | |
| Name | Takuji Okusaka |
| Address | 5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan Japan |
| Telephone | 03-3542-2511 |
| Affiliation | National Cancer Center Hospital Hepatobiliary and Pancreatic Oncology Division |