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

This study is currently recruiting participants.
Verified March 2013 by Loma Linda University
Sponsor:
Information provided by (Responsible Party):
Jacquie Limjoco, Loma Linda University
ClinicalTrials.gov Identifier:
NCT01141478
First received: May 24, 2010
Last updated: March 18, 2013
Last verified: March 2013
History of Changes

May 24, 2010
March 18, 2013
August 2010
June 2014   (final data collection date for primary outcome measure)
Overall survival [ Time Frame: On average followed for 5 years ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Time to progression [ Time Frame: On average followed for 5 years ] [ Designated as safety issue: No ]
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 Plus 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 HCC.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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
    Interventions:
    • Radiation: Proton Beam Radiotherapy
    • Drug: Sorafenib
  • Active Comparator: Sorafenib
    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
June 2016
June 2014   (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 (Appendix 1)

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 (Appendix 3)
  8. Patients with MELD score of > 25 (Appendix 4)
  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
Both
18 Years to 80 Years
No
Contact: Michael deVera, MD 909-558-3636
United States
 
NCT01141478
51000104
No
Jacquie Limjoco, Loma Linda University
Loma Linda University
Not Provided
Principal Investigator: Michael deVera, MD Loma Linda University Medical Center
Loma Linda University
March 2013

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