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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Loma Linda University
Sponsor:
Information provided by (Responsible Party):
Michael Devera, MD, Loma Linda University
ClinicalTrials.gov Identifier:
NCT01141478
First received: May 24, 2010
Last updated: May 29, 2014
Last verified: May 2014
  Purpose

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 Intervention
Carcinoma, Hepatocellular
Radiation: Proton Beam Radiotherapy
Drug: Sorafenib

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Loma Linda University:

Primary Outcome Measures:
  • Overall survival [ Time Frame: On average followed for 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 220
Study Start Date: August 2010
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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 (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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01141478

Contacts
Contact: Regina Peters 909-558-3670

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

No publications provided

Responsible Party: Michael Devera, MD, Medical Doctor, Loma Linda University
ClinicalTrials.gov Identifier: NCT01141478     History of Changes
Other Study ID Numbers: 5100104
Study First Received: May 24, 2010
Last Updated: May 29, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Loma Linda University:
Carcinoma, Hepatocellular
Proton Beam Radiotherapy
Sorafenib

Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Carcinoma
Adenocarcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Sorafenib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 19, 2014