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

This study is ongoing, but not recruiting participants.
Columbia University
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center Identifier:
First received: October 3, 2007
Last updated: March 1, 2017
Last verified: March 2017
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.

Condition Intervention Phase
Hepatocellular Carcinoma
Liver Cancer
Device: Bead Block microspheres
Other: Bead + Dox Arm
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant
Primary Purpose: Treatment
Official Title: A Randomized Single Blind Controlled Trial of Beads vs. Doxorubicin Eluting Beads for Arterial Embolization of Hepatocellular Carcinoma (HCC)

Resource links provided by NLM:

Further study details as provided by Memorial Sloan Kettering Cancer Center:

Primary Outcome Measures:
  • Response to treatment by RECIST criteria [ Time Frame: 2 to 3 weeks ]

Secondary Outcome Measures:
  • Evaluate toxicity, time to progression (TTP) and survival [ Time Frame: 1 year ]

Enrollment: 101
Actual Study Start Date: November 2007
Estimated Study Completion Date: February 2018
Estimated Primary Completion Date: February 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

Detailed Description:
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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patient with a confirmed diagnosis of HCC according to EASL criteria for diagnosis; who is not a surgical resection candidate, or refuses surgery
  • Patient must be 18 years of age or older
  • Patient must be Okuda stage I or II
  • Patient must have an ECOG performance status of 0 or 1
  • No prior chemotherapy or biotherapy within 4 weeks of scheduled embolization, with all toxicities, if any, resolved to grade < than or = to 1
  • Patient must have the following laboratory values confirmed within 14 days of registration:
  • Creatinine ≤ than or = to 2.0 the institution ULN
  • Platelets ≥ than or = to 50,000/mm3
  • INR ≤ than or = to 2.0 for patients who are not on Coumadin
  • aPTT < or = to twice control
  • Bilirubin < 3 mg/dl
  • WBC > 3000 cells/mm3
  • ANC > 1500 cells/mm3
  • Negative serum pregnancy test (Female of childbearing potential only)

Exclusion Criteria:

  • Patient has another primary tumor, with the exception of conventional basal cell CA, superficial bladder cancer, melanoma in situ, or treated prostate cancer currently without biochemical or radiographic evidence of active disease
  • Women who are pregnant or lactating
  • Patient previously treated with doxorubicin
  • Contraindication to angiography/embolization including: patients who cannot receive contrast 1.Severe allergic reaction to contrast despite pre-medication, 2. poor renal function; 3.Lack of arterial access (eg femoral artery occlusion); 4. other, based on judgment of the investigator
  • Patient has already undergone hepatic arterial embolization for the hepatocellular cancer for which they are currently being evaluated
  • Patient has received prior radiotherapy for the hepatocellular cancer for which they are currently being evaluated
  • Patient has had previous local-regional treatment of the current target tumor volume
  • Patient who cannot have CT scan
  • Patient at very high risk for post-embolization hepatic failure: 1. Child's C cirrhosis, 2. > 75% liver replaced by tumor
  • Cardiac exclusion for: 1. Myocardial infarction within 90 days of study, 2. uncontrolled arrhythmia, 3. LVEF < 50% for patients randomized to receive LC Bead
  • Patients with tumors exhibiting characteristics considered contra-indications to particle embolization, including: 1. collateral vessel pathways potentially endangering normal territories during embolization, 2. arteries supplying tumor not large enough to accept LC Bead or Bead Block, 3. Presence of arterial to systemic venous shunts, 4. Presence of arterial to pulmonary vascular shunts
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Please refer to this study by its identifier: NCT00539643

United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Columbia University
Principal Investigator: Karen T Brown, MD Memorial Sloan Kettering Cancer Center
  More Information

Additional Information:
Responsible Party: Memorial Sloan Kettering Cancer Center Identifier: NCT00539643     History of Changes
Other Study ID Numbers: 07-099
Study First Received: October 3, 2007
Last Updated: March 1, 2017

Keywords provided by Memorial Sloan Kettering Cancer Center:
Liver Cancer

Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Liver Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Liposomal doxorubicin
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on May 25, 2017