Hepatocellular Carcinoma, Intrahepatic Cholangiocarcinoma, Liver Metastases
Conditions
Keywords
liver metastases, stereotactic radiotherapy
Brief summary
This study will evaluate the local control rate as well as acute and late toxicity rates of stereotactic body radiotherapy for the treatment of liver metastases and unresectable primary liver tumors such as hepatocellular carcinoma and intrahepatic cholangiocarcinoma.
Detailed description
This study is a single site, non-randomized, prospective, phase IV trial. Composed of 4 patient groups: 1. Oligometastases (1-3) with aggregate tumor diameter \< 6 cm 2. Metastases from neuroendocrine tumors with functional endocrine syndromes 3. Unresectable hepatocellular carcinoma (HCC) 4. Unresectable intrahepatic cholangiocarcinoma (IHCC) Data collected will include patient demographics, pathology data, tumor stage, SBRT dose fractionation scheme, dose received by adjacent critical normal tissues, tumor recurrence data, and acute and late toxicities. Follow up data will be collected during the patient's standard office visits. The anticipated duration of this study is 5 years.
Interventions
RADIATIONStereotactic body radiosurgery
36-60 Gy / 3 fractions (12-20 Gy per fraction) OR 45-50 Gy / 5 fractions (9-10 Gy per fraction)
RADIATIONStereotactic Body Radiotherapy
26-30 Gy / 1 fraction OR 36-45 Gy / 3 fractions (12-15 Gy per fraction) OR 40-50 Gy / 5 fractions (8-10 Gy per fraction)
Sponsors
Mercy Research
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
* Patient age \>= 18 years * Zubrod performance status of 0-3 * Oligometastases (1-3) with aggregate tumor diameter \< 6 cm * Metastases from neuroendocrine tumors with functional endocrine syndromes for symptom palliation * Unresectable hepatocellular carcinoma (HCC) * Unresectable intrahepatic cholangiocarcinoma (IHCC) * Maximum tumor diameter \< 6 cm * Adequate liver function: Total bilirubin \< 3 mg/dL Serum albumin \> 2.5 g/dL Serum levels of liver enzymes \< 3 times the upper limit of normal Normal PT and PTT unless patient is receiving anticoagulant medication \- Signed study-specific consent form
Exclusion criteria
* Maximum tumor diameter \> 6 cm * Prior radiotherapy to the liver * Pregnant or lactating women, due to potential exposure of the fetus to RT and unknown effects of RT on lactating females * Patients with psychiatric or addictive disorder that would preclude obtaining informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Local Tumor Recurrence Rate | 5 years | Primary endpoint will be local tumor recurrence rate. Local recurrence is defined as tumor recurrence within the planning target volume. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Late Complication Rates | 5 years | Toxicities will be assessed using CTCAE grading criteria at specified timepoints. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Liver Metastases Oligometastases (1-3) with aggregate tumor diameter \< 6 cm Metastases from neuroendocrine tumors with functional endocrine syndromes
Stereotactic body radiosurgery: 36-60 Gy / 3 fractions (12-20 Gy per fraction) OR 45-50 Gy / 5 fractions (9-10 Gy per fraction) | 23 |
| Primary Liver Tumors Hepatocellular Carcinoma Intrahepatic Cholangiocarcinoma
Stereotactic Body Radiotherapy: 26-30 Gy / 1 fraction OR 36-45 Gy / 3 fractions (12-15 Gy per fraction) OR 40-50 Gy / 5 fractions (8-10 Gy per fraction) | 0 |
| Total | 23 |
Baseline characteristics
| Characteristic | Total | Liver Metastases | Primary Liver Tumors |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | — |
| Age, Categorical >=65 years | 8 Participants | 8 Participants | — |
| Age, Categorical Between 18 and 65 years | 15 Participants | 15 Participants | — |
| Age, Continuous | 63 years | 63 years | — |
| Region of Enrollment United States | 23 Participants | 23 Participants | 0 Participants |
| Sex: Female, Male Female | 12 Participants | 12 Participants | — |
| Sex: Female, Male Male | 11 Participants | 11 Participants | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 23 | 0 / 0 |
| serious Total, serious adverse events | 0 / 23 | 0 / 0 |
Outcome results
Primary
Local Tumor Recurrence Rate
Primary endpoint will be local tumor recurrence rate. Local recurrence is defined as tumor recurrence within the planning target volume.
Time frame: 5 years
Population: No patients enrolled into primary liver tumor group.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Liver Metastases | Local Tumor Recurrence Rate | 4 Participants |
| Primary Liver Tumors | Local Tumor Recurrence Rate | 0 Participants |
Secondary
Late Complication Rates
Toxicities will be assessed using CTCAE grading criteria at specified timepoints.
Time frame: 5 years
Population: This outcome was not collected.