Clinical trial · Interventional
Proton Beam Therapy for Treatment of Hepatocellular Carcinoma
Phase I/II Study of Proton Beam Therapy for Hepatocellular Carcinoma
NCT00614913CI-TRIAL-00007847completedPhase 1 / Phase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study is designed to evaluate the possible benefits and side effects of the use of proton therapy for patients with hepatocellular carcinoma.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Liver Cancer | Malignant Liver Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Proton radiation therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- 3-year Survival Without Tumor Progression for Patients Within the Milan Criteria
- timeFrame
- 3 months
- description
- Percent of participants alive and without tumor progression 3 years following treatment.
- measure
- Median Survival Without Tumor Progression
- timeFrame
- 3 months
- description
- Median time until disease progression or death
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (2)
- RESULTBush DA, Hillebrand DJ, Slater JM, Slater JD. High-dose proton beam radiotherapy of hepatocellular carcinoma: preliminary results of a phase II trial. Gastroenterology. 2004 Nov;127(5 Suppl 1):S189-93. doi: 10.1053/j.gastro.2004.09.033. PMID 15508084
- RESULTBush DA, Kayali Z, Grove R, Slater JD. The safety and efficacy of high-dose proton beam radiotherapy for hepatocellular carcinoma: a phase 2 prospective trial. Cancer. 2011 Jul 1;117(13):3053-9. doi: 10.1002/cncr.25809. Epub 2011 Jan 24. PMID 21264826