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Trial record 1 of 1 for:    NCT01668134
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Stereotactic Body Radiotherapy for Hepatocellular Carcinoma, and Intrahepatic Cholangiocarcinoma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01668134
First received: August 8, 2012
Last updated: February 16, 2017
Last verified: February 2017
  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: No masking
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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: August 8, 2012
Last Updated: February 16, 2017
Individual Participant Data  
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

ClinicalTrials.gov processed this record on June 28, 2017