Neoplasms

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Digestive System Diseases

Carcinoma

Carcinoma, Hepatocellular

Liver Neoplasms

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Adenocarcinoma

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Antineoplastic Agents

All Drugs and Chemicals

Hematinics

Doxorubicin

Liposomal doxorubicin

Liver Extracts

Hepatic arterial embolization with Bead Block microspheres, beginning with 100 - 300 micron beads, and using larger particles if necessary until stasis is evident.

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.

Bead Block (Beads) microsphere, 100-300 micron with additional larger size beads as necessary to achieve stasis

Bead Block microspheres

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.

Bead + Dox Arm

Karen T Brown, MD

The purpose of this study is to evaluate the effect of blocking the blood vessels to the tumor in your liver with small beads alone (Bead Block) versus blocking them with the same bead that contains and releases doxorubicin (a chemotherapy agent). The reason for the study is to see if adding doxorubicin kills more tumor than would be killed by just blocking the blood supplying the tumor. The chemotherapy, doxorubicin, has been used for many years to treat patients with cancer. This procedure to block the blood vessels is called embolization. Embolization is a common treatment for patients with liver cancer who cannot have surgery. The investigators are comparing the standard treatment (using the small beads alone) with another that should be at least as good, but possibly better (with the addition of the drug, doxorubicin). There is no guarantee that the new treatment is better and it is possible that there might be more side effects (related to the doxorubicin) than what is seen with the standard treatment.

Biocompatibles LC Bead (also known as DC Bead in Asia \& Europe) microspheres are preformed soft, deformable microspheres that may be loaded with doxorubicin and used to occlude blood flow to a cancerous tumour. LC Bead microspheres consist of a macromere derived from PVA. The fully polymerized microsphere is approximately 90% water and is compressible to approximately 30% by diameter. The microspheres can be delivered through conventional catheters (4-5Fr) or micro-catheters in the 2-3Fr range. These microspheres, like all agents used for arterial embolization, are mixed with radiographic contrast prior to administration in order to allow for fluoroscopic control of the embolization procedure.

Trial of Beads Versus Doxorubicin Eluting Beads for Arterial Embolization of Hepatocellular Carcinoma

A Randomized Single Blind Controlled Trial of Beads vs. Doxorubicin Eluting Beads for Arterial Embolization of Hepatocellular Carcinoma (HCC)

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

Toxicity will be graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) 3.0.

Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions

Columbia University

Memorial Sloan Kettering Cancer Center

Hepatic arterial embolization with Bead Block microspheres, beginning with 100 - 300 micron beads, and using larger particles if necessary until stasis is evident.

Bead Block microspheres: Bead Block (Beads) microsphere, 100-300 micron with additional larger size beads as necessary to achieve stasis

Bead 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.

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Trial of Beads Versus Doxorubicin Eluting Beads for Arterial Embolization of Hepatocellular Carcinoma	NCT00539643	Hepatocellular ... Liver Cancer Hepatoma	Bead Block micr... Bead + Dox Arm	18 Years -	Memorial Sloan Kettering Cancer Center
Trial of Beads Versus Doxorubicin Eluting Beads for Arterial Embolization of Hepatocellular Carcinoma	NCT00539643	Hepatocellular ... Liver Cancer Hepatoma	Bead Block micr... Bead + Dox Arm	18 Years -	Memorial Sloan Kettering Cancer Center

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