Trial of Beads Versus Doxorubicin Eluting Beads for Arterial Embolization of Hepatocellular Carcinoma
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|ClinicalTrials.gov Identifier: NCT00539643|
Recruitment Status : Active, not recruiting
First Posted : October 4, 2007
Last Update Posted : March 3, 2017
|Condition or disease||Intervention/treatment||Phase|
|Hepatocellular Carcinoma Liver Cancer Hepatoma||Device: Bead Block microspheres Other: Bead + Dox Arm||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||101 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||A Randomized Single Blind Controlled Trial of Beads vs. Doxorubicin Eluting Beads for Arterial Embolization of Hepatocellular Carcinoma (HCC)|
|Actual Study Start Date :||November 2007|
|Estimated Primary Completion Date :||February 2018|
|Estimated Study Completion Date :||February 2018|
Active Comparator: Bead Arm
Hepatic arterial embolization with Bead Block microspheres, beginning with 100 - 300 micron beads, and using larger particles if necessary until stasis is evident.
Device: Bead Block microspheres
Bead Block (Beads) microsphere, 100-300 micron with additional larger size beads as necessary to achieve stasis
Active Comparator: Bead + Dox Arm
Hepatic arterial embolization with 100-300 micron drug eluting microspheres (LC Bead) loaded with 150 mg Doxorubicin, followed by embolization with Bead Block microspheres (100-300 micron and larger size beads as necessary) until stasis is evident.
Other: Bead + Dox Arm
Bead + Dox Arm: Hepatic arterial embolization with 100-300 micron drug eluting microspheres (LC Bead) loaded with 150 mg Doxorubicin, followed by embolization with Bead Block microspheres (100-300 micron and larger size beads as necessary) until stasis is evident.
- Response to treatment by RECIST criteria [ Time Frame: 2 to 3 weeks ]
- Evaluate toxicity, time to progression (TTP) and survival [ Time Frame: 1 year ]
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): NCT00539643
|United States, New York|
|Memorial Sloan Kettering Cancer Center|
|New York, New York, United States, 10065|
|Principal Investigator:||Karen T Brown, MD||Memorial Sloan Kettering Cancer Center|