Stereotactic Body Radiotherapy for Hepatocellular Carcinoma, and Intrahepatic Cholangiocarcinoma

This study is currently recruiting participants.
Verified January 2014 by Washington University School of Medicine
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01668134
First received: August 8, 2012
Last updated: January 28, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
Carcinoma, Hepatocellular
Intrahepatic Cholangiocarcinoma
Radiation: Stereotactic radiation

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Feasibility Study of Stereotactic Body Radiotherapy for Hepatocellular Carcinoma, and Intrahepatic Cholangiocarcinoma

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

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. [ Time Frame: Up to 90 days after end of radiation therapy ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
  • Measure the overall survival rates associated with using SBRT in patients with unresectable HCC and IHC. [ Time Frame: Baseline to time of death ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: September 2009
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Stereotactic radiation Radiation: Stereotactic radiation

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 4 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 8 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01668134

Contacts
Contact: Parag Parikh, M.D. 314-362-8525 pparikh@radonc.wustl.edu
Contact: Regina Smith 314-454-7986 smithr@wudosis.wustl.edu

Locations
United States, Missouri
Washington University School of Medicine Recruiting
St. Louis, Missouri, United States, 63110
Contact: Parag Parikh, M.D.    314-362-8525    pparikh@radonc.wustl.edu   
Sub-Investigator: William Chapman, M.D.         
Sub-Investigator: Maria Doyle, M.D.         
Sub-Investigator: Michael Darcy, M.D.         
Sub-Investigator: Neal Saad, M.D.         
Sub-Investigator: Darryl Zuckerman, M.D.         
Sub-Investigator: Kevin Korenblat, M.D.         
Sub-Investigator: Jeffrey Crippin, M.D.         
Sub-Investigator: Mauricio Lisker-Melman, M.D.         
Sub-Investigator: Benjamin Tan, M.D.         
Sub-Investigator: Andrea Wang-Gillam, M.D., Ph.D.         
Sub-Investigator: Joel Picus, M.D.         
Sub-Investigator: Rama Suresh, M.D.         
Sub-Investigator: Steven Sorscher, M.D.         
Sub-Investigator: Kathryn Fowler, M.D.         
Sub-Investigator: Todd DeWees, Ph.D.         
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Parag Parikh, M.D. Washington University School of Medicine
  More Information

No publications provided

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01668134     History of Changes
Other Study ID Numbers: 09-1345 / 201107319
Study First Received: August 8, 2012
Last Updated: January 28, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Cholangiocarcinoma
Carcinoma
Liver Neoplasms
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases

ClinicalTrials.gov processed this record on April 17, 2014