Hepatocellular Carcinoma, Liver Cancer
Conditions
Keywords
Proton, Radiotherapy, Hepatocellular carcinoma, Liver Cancer
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.
Interventions
RADIATIONProton radiation therapy
A total dose of 63 Gy will be delivered in 15 equally divided daily fractions over a 3 week coarse as an out-patient.
Sponsors
Loma Linda University
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 3-year Survival Without Tumor Progression for Patients Within the Milan Criteria | 3 months | Percent of participants alive and without tumor progression 3 years following treatment. |
| Median Survival Without Tumor Progression | 3 months | Median time until disease progression or death |
Countries
United States
Participant flow
Recruitment details
Patients with a diagnosis of hepatocellular carcinoma were recruited from the hepatology clinic at Loma Linda University Medical Center to participate in this trial.
Pre-assignment details
Patients with documented metastatic disease were excluded from this trial.
Participants by arm
| Arm | Count |
|---|---|
| Proton Beam Therapy Patients received 63Gy in three weeks with proton beam. | 76 |
| Total | 76 |
Baseline characteristics
| Characteristic | Proton Beam Therapy |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 37 Participants |
| Age, Categorical Between 18 and 65 years | 39 Participants |
| Age Continuous | 62.7 years STANDARD_DEVIATION 5.8 |
| Region of Enrollment United States | 76 participants |
| Sex: Female, Male Female | 23 Participants |
| Sex: Female, Male Male | 53 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 76 |
| serious Total, serious adverse events | 5 / 76 |
Outcome results
Primary
3-year Survival Without Tumor Progression for Patients Within the Milan Criteria
Percent of participants alive and without tumor progression 3 years following treatment.
Time frame: 3 months
Population: Participants that were within the Milan criteria
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Proton Beam Therapy | 3-year Survival Without Tumor Progression for Patients Within the Milan Criteria | 60 percentage of participants |
Primary
Median Survival Without Tumor Progression
Median time until disease progression or death
Time frame: 3 months
Population: All participants
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Proton Beam Therapy | Median Survival Without Tumor Progression | 36 months |