Know Cancer

or
forgot password

Randomized Controlled Trial of Proton Beam Radiotherapy Plus Sorafenib vs. Sorafenib for Patients With Hepatocellular Carcinoma Exceeding San Francisco Criteria


N/A
18 Years
80 Years
Open (Enrolling)
Both
Carcinoma, Hepatocellular

Thank you

Trial Information

Randomized Controlled Trial of Proton Beam Radiotherapy Plus Sorafenib vs. Sorafenib for Patients With Hepatocellular Carcinoma Exceeding San Francisco 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall survival

Outcome Time Frame:

On average followed for 5 years

Safety Issue:

No

Principal Investigator

Michael deVera, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Loma Linda University Medical Center

Authority:

United States: Institutional Review Board

Study ID:

51000104

NCT ID:

NCT01141478

Start Date:

August 2010

Completion Date:

June 2016

Related Keywords:

  • Carcinoma, Hepatocellular
  • Carcinoma, Hepatocellular
  • Proton Beam Radiotherapy
  • Sorafenib
  • Carcinoma
  • Carcinoma, Hepatocellular

Name

Location

Loma Linda University Medical CenterLoma Linda, California  92354