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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):
Michael Devera, MD, Loma Linda University

May 24, 2010
June 10, 2010
November 4, 2016
August 2010
June 2017   (Final data collection date for primary outcome measure)
Overall survival [ Time Frame: On average followed for 5 years ]
Same as current
Complete list of historical versions of study NCT01141478 on ClinicalTrials.gov Archive Site
To assess the radiological progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: On average followed for 5 years ]
Time to progression [ Time Frame: On average followed for 5 years ]
Not Provided
Not Provided
 
Proton Beam Radiotherapy Plus Sorafenib Versus Sorafenib for Patients With Hepatocellular Carcinoma Exceeding San Francisco Criteria
Randomized Controlled Trial of Proton Beam Radiotherapy + Sorafenib vs. Sorafenib for Patients With Hepatocellular Carcinoma Exceeding San Francisco Criteria
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.
Not Provided
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Carcinoma, Hepatocellular
  • Radiation: Proton Beam Radiotherapy
    Fifteen consecutive sessions
  • Drug: Sorafenib
    400 mg po bid
  • 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.
    Interventions:
    • Radiation: Proton Beam Radiotherapy
    • Drug: Sorafenib
  • Active Comparator: Sorafenib
    Sorafenib is an oral pill taken daily to inhibit tumor growth at the cellular level.
    Intervention: Drug: Sorafenib
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
220
Same as current
June 2018
June 2017   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Older Adult)
No
Contact: Diane Scavone 909-558-3636 DScavone@llu.edu
United States
 
 
NCT01141478
5100104
No
Not Provided
Not Provided
Michael Devera, MD, Loma Linda University
Loma Linda University
Not Provided
Principal Investigator: Michael deVera, MD Loma Linda University Medical Center
Loma Linda University
November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP