TerminatedNot Applicable

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

Stopped: due to low enrollment

United States8 participantsStarted 2010-09-08

Plain-language 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.

Who can participate

Age range18 Years – 80 Years

SexALL

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Inclusion criteria

✓. Patients are candidates to receive both proton beam and sorafenib
✓. Patients with tumor burden that exceeds San Francisco criteria

Exclusion criteria

✕. Patients who are candidates for surgical resection
✕. Patients with tumor burden within Milan and/or San Francisco criteria
✕. Patients who have contraindication to receive proton
✕. Patients with contraindication to receive sorafenib including uncontrolled hypertension, coumadin treatment and prior intolerability to the drug
✕. Patients treated previously by any locoregional treatment
✕. Patients with prior liver transplant
✕. Patients with child class C
✕. Patients with model for end-stage liver disease (MELD) score of \> 25

What they're measuring

Overall Survival Rate Between Time of Consent and Time of Death

Timeframe: Change between time of informed consent and primary completion date of study, an average of 4 years per participant

Trial details

NCT IDNCT01141478

SponsorLoma Linda University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2014-12-26

Results submitted2017-09-12

View on ClinicalTrials.gov More Carcinoma, Hepatocellular trials