Proton Radiotherapy Plus Sorafenib Versus Sorafenib for Patients With HCC Exceeding San Francisco Criteria

Carcinoma, Hepatocellular Clinical Trial

— HCC  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01141478
• Other study ID #: 5100104
• Status: Terminated
• Phase: N/A
• Start date: September 8, 2010
• Est. completion date: June 10, 2016

Study information

• Verified date: September 2021
• Source: Loma Linda University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: June 10, 2016
• Est. primary completion date: December 26, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular

Intervention

Radiation:
• Proton Beam Radiotherapy
Fifteen consecutive sessions

Drug:
• Sorafenib
400 mg po bid

Locations

Country	Name	City	State
United States	Loma Linda University Medical Center	Loma Linda	California

Sponsors (1)

Lead Sponsor	Collaborator
Loma Linda University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival Rate Between Time of Consent and Time of Death	All subjects are to be followed from time of consent until time of death. Subjects in both arms will require either a CT scan or MRI of the abdomen every three months to monitor tumor progression. Follow up imaging with be the same modality used at baseline (CT or MRI). All subjects are to be evaluated in the liver clinic 4 weeks after treatment and then every 3 months. Subjects in the Proton arm will require a CT or MRI 4-6 weeks after treatment and then every three months. Subjects receiving Proton therapy will also be followed in the radiation medicine clinic by their treating radiation oncologist every 3 months for the first year and then every 6 months.	Change between time of informed consent and primary completion date of study, an average of 4 years per participant