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Stereotactic Body Radiotherapy for Liver Tumors

Primary Purpose

Liver Metastases, Hepatocellular Carcinoma, Intrahepatic Cholangiocarcinoma

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Stereotactic body radiosurgery

Stereotactic Body Radiotherapy

About this trial

This is an interventional treatment trial for Liver Metastases focused on measuring liver metastases, stereotactic radiotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

St. John's Mercy Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Arm Label

liver metastases

Primary Liver Tumors

Arm Description

Oligometastases (1-3) with aggregate tumor diameter < 6 cm Metastases from neuroendocrine tumors with functional endocrine syndromes

Hepatocellular Carcinoma Intrahepatic Cholangiocarcinoma

Outcomes

Primary Outcome Measures

Local Tumor Recurrence Rate

Primary endpoint will be local tumor recurrence rate. Local recurrence is defined as tumor recurrence within the planning target volume.

Secondary Outcome Measures

Late Complication Rates

Toxicities will be assessed using CTCAE grading criteria at specified timepoints.

Full Information

NCT ID

NCT01347333

First Posted

May 2, 2011

Last Updated

February 19, 2020

Sponsor

Mercy Research

1. Study Identification

Unique Protocol Identification Number

NCT01347333

Brief Title

Stereotactic Body Radiotherapy for Liver Tumors

Official Title

Phase IV Trial Evaluating the Use of Stereotactic Body Radiotherapy for the Treatment of Liver Metastases and Primary Liver Tumors

Study Type

Interventional

2. Study Status

Record Verification Date

February 2020

Overall Recruitment Status

Completed

Study Start Date

September 2008 (undefined)

Primary Completion Date

September 2016 (Actual)

Study Completion Date

September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Mercy Research

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Data Monitoring Committee

5. Study Description

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: Oligometastases (1-3) with aggregate tumor diameter < 6 cm Metastases from neuroendocrine tumors with functional endocrine syndromes Unresectable hepatocellular carcinoma (HCC) 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Liver Metastases, Hepatocellular Carcinoma, Intrahepatic Cholangiocarcinoma

Keywords

liver metastases, stereotactic radiotherapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

23 (Actual)

8. Arms, Groups, and Interventions

Arm Title

liver metastases

Arm Type

Other

Arm Description

Oligometastases (1-3) with aggregate tumor diameter < 6 cm Metastases from neuroendocrine tumors with functional endocrine syndromes

Arm Title

Primary Liver Tumors

Arm Type

Other

Arm Description

Hepatocellular Carcinoma Intrahepatic Cholangiocarcinoma

Intervention Type

Radiation

Intervention Name(s)

Stereotactic body radiosurgery

Intervention Description

36-60 Gy / 3 fractions (12-20 Gy per fraction) OR 45-50 Gy / 5 fractions (9-10 Gy per fraction)

Intervention Type

Radiation

Intervention Name(s)

Stereotactic Body Radiotherapy

Intervention Description

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)

Primary Outcome Measure Information:

Title

Local Tumor Recurrence Rate

Description

Primary endpoint will be local tumor recurrence rate. Local recurrence is defined as tumor recurrence within the planning target volume.

Time Frame

5 years

Secondary Outcome Measure Information:

Title

Late Complication Rates

Description

Toxicities will be assessed using CTCAE grading criteria at specified timepoints.

Time Frame

5 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bethany G Sleckman, MD

Organizational Affiliation

Mercy Hospital St. Louis

Official's Role

Study Director

Facility Information:

Facility Name

St. John's Mercy Medical Center

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63141

Country

United States

12. IPD Sharing Statement

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Stereotactic Body Radiotherapy for Liver Tumors

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