Stereotactic Body Radiotherapy for Hepatocellular Carcinoma, and Intrahepatic Cholangiocarcinoma

Feasibility Study of Stereotactic Body Radiotherapy for Hepatocellular Carcinoma, and Intrahepatic Cholangiocarcinoma

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.

Study Overview

• Status: Completed
• Conditions: Carcinoma, Hepatocellular; Intrahepatic Cholangiocarcinoma
• Intervention / Treatment: Radiation: Stereotactic radiation

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Missouri
    • St. Louis, Missouri, United States, 63110
      • Washington University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Stereotactic radiation	Radiation: Stereotactic radiation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Washington University School of Medicine

Publications and helpful links

Helpful Links

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): December 16, 2009
• Primary Completion (Actual): August 30, 2014
• Study Completion (Actual): December 22, 2015

Study Registration Dates

• First Submitted: August 8, 2012
• First Submitted That Met QC Criteria: August 15, 2012
• First Posted (Estimate): August 17, 2012

Study Record Updates

• Last Update Posted (Actual): February 20, 2017
• Last Update Submitted That Met QC Criteria: February 16, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Digestive System Neoplasms; Liver Diseases; Liver Neoplasms; Carcinoma; Carcinoma, Hepatocellular; Cholangiocarcinoma
• Other Study ID Numbers: 09-1345 / 201107319

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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