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Trial record 1 of 1 for:    NCT01141478
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Proton Beam Radiotherapy Plus Sorafenib Versus Sorafenib for Patients With Hepatocellular Carcinoma Exceeding San Francisco Criteria

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: NCT01141478
Recruitment Status : Unknown
Verified November 2016 by Michael Devera, MD, Loma Linda University.
Recruitment status was:  Recruiting
First Posted : June 10, 2010
Last Update Posted : November 4, 2016
Information provided by (Responsible Party):
Michael Devera, MD, Loma Linda University

Brief Summary:
This study is designed to determine whether proton beam radiotherapy plus Sorafenib compared to Sorafenib alone will produce the best results for treating patients with Hepatocellular Carcinoma.

Condition or disease Intervention/treatment Phase
Carcinoma, Hepatocellular Radiation: Proton Beam Radiotherapy Drug: Sorafenib Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial of Proton Beam Radiotherapy + Sorafenib vs. Sorafenib for Patients With Hepatocellular Carcinoma Exceeding San Francisco Criteria
Study Start Date : August 2010
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Sorafenib

Arm Intervention/treatment
Active Comparator: Proton Beam Radiotherapy plus Sorafenib
A combination of radiation therapy (proton) to kill tumor cells as well as Sorafenib which is a study drug administered to patients to stop tumor growth.
Radiation: Proton Beam Radiotherapy
Fifteen consecutive sessions

Drug: Sorafenib
400 mg po bid

Active Comparator: Sorafenib
Sorafenib is an oral pill taken daily to inhibit tumor growth at the cellular level.
Drug: Sorafenib
400 mg po bid

Primary Outcome Measures :
  1. Overall survival [ Time Frame: On average followed for 5 years ]

Secondary Outcome Measures :
  1. To assess the radiological progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: On average followed for 5 years ]

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 sorafenib
  2. Patients with tumor burden that exceeds San Francisco criteria

Exclusion Criteria:

  1. Patients who are candidates for surgical resection
  2. Patients with tumor burden within Milan and/or San Francisco criteria
  3. Patients who have contraindication to receive proton
  4. Patients with contraindication to receive sorafenib including uncontrolled hypertension, coumadin treatment and prior intolerability to the drug
  5. Patients treated previously by any locoregional treatment
  6. Patients with prior liver transplant
  7. Patients with child class C
  8. Patients with model for end-stage liver disease (MELD) score of > 25
  9. Patients with other comorbid diseases that may impact survival
  10. Patients with ongoing alcohol intake
  11. Patients with active sepsis
  12. Patients with gastrointestinal bleeding within a week
  13. Patients unwilling to sign informed consent form
  14. 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): NCT01141478

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Contact: Diane Scavone 909-558-3636

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United States, California
Loma Linda University Medical Center Recruiting
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: NCT01141478    
Other Study ID Numbers: 5100104
First Posted: June 10, 2010    Key Record Dates
Last Update Posted: November 4, 2016
Last Verified: November 2016
Keywords provided by Michael Devera, MD, Loma Linda University:
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
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action