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Stereotactic Body Radiotherapy for Hepatocellular Carcinoma, and Intrahepatic Cholangiocarcinoma

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01668134
First Posted: August 17, 2012
Last Update Posted: February 20, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Washington University School of Medicine
  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 Phase
Carcinoma, Hepatocellular Intrahepatic Cholangiocarcinoma Radiation: Stereotactic radiation Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (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 ]

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 ]
  • 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 ]
  • Measure the overall survival rates associated with using SBRT in patients with unresectable HCC and IHC. [ Time Frame: Baseline to time of death ]
  • 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 ]

Enrollment: 28
Actual Study Start Date: December 16, 2009
Study Completion Date: December 22, 2015
Primary Completion Date: August 30, 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Stereotactic radiation Radiation: Stereotactic radiation

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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 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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01668134


Locations
United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Parag Parikh, M.D. Washington University School of Medicine
  More Information

Additional Information:
Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01668134     History of Changes
Other Study ID Numbers: 09-1345 / 201107319
First Submitted: August 8, 2012
First Posted: August 17, 2012
Last Update Posted: February 20, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

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