Phase 2
Completed N=76
Proton Beam Therapy for Treatment of Hepatocellular Carcinoma
Source: ClinicalTrials.gov NCT00614913 ↗Enrolled (actual)
76
Serious AEs
6.6%
Results posted
Aug 2012
Primary outcomePrimary: 3-year Survival Without Tumor Progression for Patients Within the Milan Criteria — 60 percentage of participants
Summary
This study is designed to evaluate the possible benefits and side effects of the use of proton therapy for patients with hepatocellular carcinoma.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 3-year Survival Without Tumor Progression for Patients Within the Milan Criteria |
60 | — |
| PRIMARY Median Survival Without Tumor Progression |
36 | — |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of hepatocellular carcinoma
- Adult patients aged 18 years old and above
- Ability to give informed consent for study
- Compensated liver disease
Exclusion Criteria
- Pediatric patients (aged less than 18 years old)
- Decompensated or advanced liver disease
- Poorly controlled ascites
- Variceal hemorrhage within the previous 30 days
- Recurrent hepatic encephalopathy
- Cirrhosis with CTP* score >10
- Active alcohol or drug abuse
- Anticipated survival of less than 30 days
- Advanced co-morbid medical illnesses
- Karnofsky Performance Score <60
Tumor characteristics:
- Any tumor that can not be safely and effectively irradiated due to inability to deliver target treatment dose to required treatment volume or due to prohibitively high risk of anticipated toxicities to normal liver or nearby bowel, stomach, kidney or spinal cord.
Data sourced from ClinicalTrials.gov (NCT00614913). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.