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Stereotactic Body Radiotherapy for Hepatocellular Carcinoma, and Intrahepatic Cholangiocarcinoma

Primary Purpose

Carcinoma, Hepatocellular, Intrahepatic Cholangiocarcinoma

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Stereotactic radiation
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carcinoma, Hepatocellular

Eligibility Criteria

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

Inclusion Criteria:

  • Age ≥ 18
  • Karnofsky Performance Status of ≥ 60
  • Pathologically confirmed IHC or HCC. (Pathology not required for HCC if the lesion enhances typically on MRI and the patient is evaluated by liver transplant surgery team and thought to have HCC.)
  • 4 or less separate intrahepatic lesions, with at least one lesion that is able to be followed by EASL Criteria.
  • Local surgical resection is not possible due to tumor or patient factors
  • Limited metastatic disease is allowed if the volume of metastatic disease does not exceed the volume of primary disease.
  • Prior TACE allowed if stopped/completed at least 2 weeks prior to enrollment
  • Prior chemotherapy except Sorafenib allowed if stopped/completed at least 2 weeks prior to enrollment
  • Prior Sorafenib allowed if stopped/completed at least seven days prior to enrollment.
  • Able to provide signed informed consent

Exclusion Criteria:

  • Childs-Pugh score 9 or more
  • ALT or AST ≥ 6 x upper limit of normal
  • Prior history of abdominal irradiation
  • Women who are pregnant or nursing
  • Scheduled to undergo chemotherapy except Sorafenib at the time when radiation therapy will be given, or for up to 4 weeks after completion of radiation therapy.
  • Scheduled to undergo Sorafenib within seven days of when radiation therapy will be delivered, or for up to 2 weeks after completion of radiation therapy.
  • Undergone prior radiation therapy to the abdomen.

Sites / Locations

  • Washington University School of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Stereotactic radiation

Arm Description

Outcomes

Primary Outcome Measures

Stereotactic radiation therapy (either photon or proton) can be delivered to the liver with a less than 10% 3-month incidence of Grade 4 study related toxicity.

Secondary Outcome Measures

Measure the late toxicity associated with using stereotactic radiation therapy in patients with unresectable HCC and IHC.
Measure the local recurrence rates associated with using SBRT in patients with unresectable HCC and IHC.
Measure the overall survival rates associated with using SBRT in patients with unresectable HCC and IHC.
Measure the response rates associated with using SBRT in patients with resectable HCC and IHC

Full Information

First Posted
August 8, 2012
Last Updated
February 16, 2017
Sponsor
Washington University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT01668134
Brief Title
Stereotactic Body Radiotherapy for Hepatocellular Carcinoma, and Intrahepatic Cholangiocarcinoma
Official Title
Feasibility Study of Stereotactic Body Radiotherapy for Hepatocellular Carcinoma, and Intrahepatic Cholangiocarcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
December 16, 2009 (Actual)
Primary Completion Date
August 30, 2014 (Actual)
Study Completion Date
December 22, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study is being done to determine if targeted radiation therapy (stereotactic) can be given to treat liver cancer, for patient who are unable to undergo surgery, over a short period of time with a small amount of side effects.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Hepatocellular, Intrahepatic Cholangiocarcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Stereotactic radiation
Arm Type
Experimental
Intervention Type
Radiation
Intervention Name(s)
Stereotactic radiation
Primary Outcome Measure Information:
Title
Stereotactic radiation therapy (either photon or proton) can be delivered to the liver with a less than 10% 3-month incidence of Grade 4 study related toxicity.
Time Frame
Up to 90 days after end of radiation therapy
Secondary Outcome Measure Information:
Title
Measure the late toxicity associated with using stereotactic radiation therapy in patients with unresectable HCC and IHC.
Time Frame
Up to 60 days after end of radiation therapy
Title
Measure the local recurrence rates associated with using SBRT in patients with unresectable HCC and IHC.
Time Frame
Time of treatment until recurrance or progressive disease as measured by CT/MR from baseline to recurrance or progressive disease
Title
Measure the overall survival rates associated with using SBRT in patients with unresectable HCC and IHC.
Time Frame
Baseline to time of death
Title
Measure the response rates associated with using SBRT in patients with resectable HCC and IHC
Time Frame
Baseline to the first date of recurrance or progressive disease

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥ 18 Karnofsky Performance Status of ≥ 60 Pathologically confirmed IHC or HCC. (Pathology not required for HCC if the lesion enhances typically on MRI and the patient is evaluated by liver transplant surgery team and thought to have HCC.) 4 or less separate intrahepatic lesions, with at least one lesion that is able to be followed by EASL Criteria. Local surgical resection is not possible due to tumor or patient factors Limited metastatic disease is allowed if the volume of metastatic disease does not exceed the volume of primary disease. Prior TACE allowed if stopped/completed at least 2 weeks prior to enrollment Prior chemotherapy except Sorafenib allowed if stopped/completed at least 2 weeks prior to enrollment Prior Sorafenib allowed if stopped/completed at least seven days prior to enrollment. Able to provide signed informed consent Exclusion Criteria: Childs-Pugh score 9 or more ALT or AST ≥ 6 x upper limit of normal Prior history of abdominal irradiation Women who are pregnant or nursing Scheduled to undergo chemotherapy except Sorafenib at the time when radiation therapy will be given, or for up to 4 weeks after completion of radiation therapy. Scheduled to undergo Sorafenib within seven days of when radiation therapy will be delivered, or for up to 2 weeks after completion of radiation therapy. Undergone prior radiation therapy to the abdomen.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Parag Parikh, M.D.
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University School of Medicine
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://siteman.wustl.edu
Description
Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

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Stereotactic Body Radiotherapy for Hepatocellular Carcinoma, and Intrahepatic Cholangiocarcinoma

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