Stereotactic Body Radiotherapy for Liver Tumors
| Status: | Completed |
|---|---|
| Conditions: | Liver Cancer, Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/28/2018 |
| Start Date: | September 2008 |
| End Date: | September 2016 |
Phase IV Trial Evaluating the Use of Stereotactic Body Radiotherapy for the Treatment of Liver Metastases and Primary Liver Tumors
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.
stereotactic body radiotherapy for the treatment of liver metastases and unresectable primary
liver tumors such as hepatocellular carcinoma and intrahepatic cholangiocarcinoma.
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.
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.
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
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