Stereotactic Body Radiotherapy for Hepatocellular Carcinoma, and Intrahepatic Cholangiocarcinoma

Phase 1

Completed

• Conditions: Carcinoma, Hepatocellular; Intrahepatic Cholangiocarcinoma
• Interventions: Radiation: Stereotactic radiation

• Registration Number: NCT01668134
• Lead Sponsor: Washington University School of Medicine

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2009-12-16
• Study First Submitted: 2012-08-08
• Study First Submitted QC: 2012-08-15
• Study First Posted: 2012-08-17
• Primary Completion: 2014-08-30
• Study Completion: 2015-12-22
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-16
• Last Update Posted: 2017-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Stereotactic radiation	Stereotactic radiation	-

Primary Outcome Measures

Name	Time	Method
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.	Up to 90 days after end of radiation therapy

Secondary Outcome Measures

Name	Time	Method
Measure the overall survival rates associated with using SBRT in patients with unresectable HCC and IHC.	Baseline to time of death
Measure the response rates associated with using SBRT in patients with resectable HCC and IHC	Baseline to the first date of recurrance or progressive disease
Measure the late toxicity associated with using stereotactic radiation therapy in patients with unresectable HCC and IHC.	Up to 60 days after end of radiation therapy
Measure the local recurrence rates associated with using SBRT in patients with unresectable HCC and IHC.	Time of treatment until recurrance or progressive disease as measured by CT/MR from baseline to recurrance or progressive disease

Trial Locations

Locations (1)

Washington University School of Medicine; 🇺🇸 St. Louis, Missouri, United States