Stereotactic Body Radiotherapy for Liver Tumors
Basic Trial Information
|Phase IV||Treatment||Closed||18 and over||Other||08-045|
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.
Further Study Information
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.
- 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
- 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
Trial Contact Information
Trial Lead Organizations/Sponsors
David C. Pratt Cancer Center at St. John's Mercy
Link to the current ClinicalTrials.gov record.
NLM Identifier NCT01347333
ClinicalTrials.gov processed this data on April 09, 2015
Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.