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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01141478
Other study ID # 5100104
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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