Stereotactic Body Radiotherapy for Hepatocellular Carcinoma, and Intrahepatic Cholangiocarcinoma
This study is currently recruiting participants.
Verified May 2013 by Washington University School of Medicine
Sponsor:
Washington University School of Medicine
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01668134
First received: August 8, 2012
Last updated: May 22, 2013
Last verified: May 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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
Additional 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: | May 22, 2013 |
| 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 May 23, 2013