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Transarterial Chemoembolization Versus Proton Beam Radiotherapy for the Treatment of Hepatocellular Carcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00857805
Recruitment Status : Active, not recruiting
First Posted : March 9, 2009
Last Update Posted : October 28, 2020
Information provided by (Responsible Party):
Michael Devera, MD, Loma Linda University

Brief Summary:
Patients with liver tumor burden that exceeds Milan criteria are considered to receive one of the following locoregional treatments: transarterial chemoembolization (TACE), radiofrequency ablation (RFA), percutaneous ethanol injection and proton beam radiation (PBR). The goals of these treatments are to control tumor growth, to downstage tumor size to meet Milan criteria, and to improve survival. Patients who exceed the Milan criteria benefit from tumor downstaging as a result of treatment. Patients who meet Milan criteria benefit from tumor control to bridge them to liver transplantation. TACE is considered the most common locoregional treatment that is used to treat hepatocellular carcinoma (HCC). Proton beam radiotherapy has been used in treating HCC in a few centers across the globe. Phase I and II trials showed a satisfactory safety and efficacy results. Loma Linda University Medical Center is one of these pioneering centers that use proton beam as a treatment for HCC. This is the first randomized trial in the medical field that will compare head-to-head the efficacy of TACE versus proton beam in treating HCC patients.

Condition or disease Intervention/treatment Phase
Carcinoma, Hepatocellular Procedure: Transarterial Chemoembolization Radiation: Proton Beam Radiotherapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial of Transarterial Chemoembolization Versus Proton Beam Radiotherapy for the Treatment of Hepatocellular Carcinoma
Study Start Date : January 2009
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : January 2022

Arm Intervention/treatment
Active Comparator: Transarterial Chemoembolization
Transarterial Chemoembolization
Procedure: Transarterial Chemoembolization
Application of carboplatin, doxorubicin in ethiodol into the artery for one or more sessions.
Other Name: (TACE)

Active Comparator: Proton Beam Radiotherapy
Proton Beam Radiotherapy
Radiation: Proton Beam Radiotherapy
Fifteen consecutive sessions

Primary Outcome Measures :
  1. Overall survival [ Time Frame: lifetime ]

Secondary Outcome Measures :
  1. Time to progression [ Time Frame: Lifetime ]
  2. Downstaging [ Time Frame: Lifetime ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Patients are candidates to receive both proton beam and TACE
  2. Patients with no evidence of metastasis or macrovascular invasion
  3. Patients with tumor burden that meets San Francisco criteria

Exclusion Criteria:

  1. Patients who are candidates for surgical resection
  2. Patients with lesion < 2 cm
  3. Patients who have contraindication to receive either TACE or proton
  4. Patients with serum alpha fetoprotein > 500
  5. Patients with metastasis or macrovascular invasion
  6. Patients treated previously for HCC by any locoregional treatment
  7. Patients with prior liver transplant
  8. Patients with Child class C
  9. Patients with MELD score of > 25
  10. Patients with other comorbid diseases that may impact survival
  11. Patients with ongoing alcohol intake
  12. Patients with active sepsis
  13. Patients with gastrointestinal bleeding within a week
  14. Patients unwilling to sign informed consent form
  15. Patients with history of noncompliance

Information from the National Library of Medicine

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 identifier (NCT number): NCT00857805

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United States, California
Loma Linda University Medical Center
Loma Linda, California, United States, 92354
Sponsors and Collaborators
Loma Linda University
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Principal Investigator: Michael deVera, MD Loma Linda University Medical Center
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Responsible Party: Michael Devera, MD, Medical Doctor, Loma Linda University Identifier: NCT00857805    
Other Study ID Numbers: 58348
First Posted: March 9, 2009    Key Record Dates
Last Update Posted: October 28, 2020
Last Verified: October 2020
Keywords provided by Michael Devera, MD, Loma Linda University:
Transarterial chemoembolization
Carcinoma, Hepatocellular
Proton Beam Radiotherapy
Additional relevant MeSH terms:
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Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases