Ignite Creation Date:
2025-12-25 @ 2:41 AM
Ignite Modification Date:
2025-12-30 @ 7:44 PM
Study NCT ID:
NCT01347333
Status:
COMPLETED
Last Update Posted:
2020-03-03
First Post:
2011-05-02
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Stereotactic Body Radiotherapy for Liver Tumors
Sponsor:
Mercy Research
Organization:
Study Overview
Official Title:
Phase IV Trial Evaluating the Use of Stereotactic Body Radiotherapy for the Treatment of Liver Metastases and Primary Liver Tumors
Status:
COMPLETED
Status Verified Date:
2020-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: