Clinical trial NCT00614913: Proton Beam Therapy for Treatment of Hepatocellular Carcinoma
Official title: Phase I/II Study of Proton Beam Therapy for Hepatocellular Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Liver Cancer
Hepatocellular Carcinoma
Keywords: Proton
Radiotherapy
Hepatocellular carcinoma
Liver Cancer
Lead sponsor: Loma Linda University
Sponsor class: OTHER
First posted: 2008-02-13
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is designed to evaluate the possible benefits and side effects of the use of proton therapy for patients with hepatocellular carcinoma.

Detailed description: Hepatocellular carcinoma (HCC) is a type of primary cancer of the liver that is being diagnosed in the U.S. population with increasing frequency. While surgery is the first line of treatment, many patients are not eligible for surgical removal. Current non-surgical treatments for HCC are not fully effective and can have substantial side-effects. This study utilizes a type of radiation treatment called proton beam that can deliver high doses of radiotherapy to tumors within the liver while minimizing damage to surrounding healthy tissues. The treatment is non-invasive and is given on an out-patient basis over a three week coarse. The study will evaluate the effectiveness and side-effects of this therapy by tracking patient's outcomes following treatment.

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.

Primary outcomes:
measure: 3-year Survival Without Tumor Progression for Patients Within the Milan Criteria
timeFrame: 3 months
measure: Median Survival Without Tumor Progression
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda University Medical Center / James M. Slater Proton Treatment Center
state: California
Study officials:
affiliation: Loma Linda University Dept. of Radiation Medicine
name: David A Bush, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Loma Linda University Department of Radiation Medicine
name: Jerry D Slater, MD
role: STUDY_CHAIR
References:
citation: Bush 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.
citation: Bush 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.