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Proton Beam Radiotherapy Plus Sorafenib Versus Sorafenib for Patients With Hepatocellular Carcinoma Exceeding San Francisco Criteria

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ClinicalTrials.gov Identifier: NCT01141478
Recruitment Status : Recruiting
First Posted : June 10, 2010
Last Update Posted : November 4, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
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
Carcinoma, Hepatocellular Radiation: Proton Beam Radiotherapy Drug: Sorafenib

Study Design

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

U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

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 ]

Eligibility Criteria

Information from the National Library of Medicine

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

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
Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT01141478


Contacts
Contact: Diane Scavone 909-558-3636 DScavone@llu.edu

Locations
United States, California
Loma Linda University Medical Center Recruiting
Loma Linda, California, United States, 92354
Sponsors and Collaborators
Loma Linda University
Investigators
Principal Investigator: Michael deVera, MD Loma Linda University Medical Center
More Information

Responsible Party: Michael Devera, MD, Medical Doctor, Loma Linda University
ClinicalTrials.gov Identifier: NCT01141478     History of Changes
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
Sorafenib

Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Sorafenib
Niacinamide
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs