A Study of Individualized Stereotactic Body Radiation Therapy (SBRT) for Intrahepatic Cancer
This study is currently recruiting participants.
Verified February 2013 by University of Michigan Cancer Center
Sponsor:
University of Michigan Cancer Center
Information provided by (Responsible Party):
University of Michigan Cancer Center
ClinicalTrials.gov Identifier:
NCT01522937
First received: September 23, 2011
Last updated: February 14, 2013
Last verified: February 2013
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Purpose
This is a Phase II trial to characterize the safety and efficacy of individualized stereotactic body radiation therapy (SRBT) for patients who have had previous liver treatment or who have primary hepatocellular carcinoma (HCC).
| Condition | Intervention | Phase |
|---|---|---|
|
Liver Cancer Hepatocellular Cancer |
Radiation: individualized Stereotactic Body Radiation Therapy (SBRT) |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Study of Individualized Stereotactic Body Radiation Therapy (SBRT) for Intrahepatic Cancer |
Resource links provided by NLM:
Further study details as provided by University of Michigan Cancer Center:
Primary Outcome Measures:
- Tumor measure rates [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]Tumor size will be measured every 2 months following treatment to assess for shrinkage, stability of size, or increasing size. Adverse events will also be monitored every 2 months to assess for safety.
Secondary Outcome Measures:
- assessment of plasma biomarkers for liver function [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]Collect data on plasma biomarkers of liver function to plan further enhancements to individualized SBRT
| Estimated Enrollment: | 70 |
| Study Start Date: | October 2009 |
| Estimated Study Completion Date: | January 2016 |
| Estimated Primary Completion Date: | January 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Liver cancer patients
The aim of this study is to determine the safety and effectiveness of individualized Stereotactic Body Radiation Therapy (SBRT) in patients who either (1) have had previous liver treatments, and/or (2) have primary hepatocellular carcinoma (HCC).
|
Radiation: individualized Stereotactic Body Radiation Therapy (SBRT)
The individualized SBRT involves two treatment phases. The first phase of treatment involves receiving three fractions of SBRT, followed by a 1-month break and assessment of liver function with a blood test - Indocyanine Green (IC-Green). The second phase of treatment involves receiving two more fractions of SBRT, whose doses are adjusted to account for tolerance of the first phase of treatment.
|
Detailed Description:
The trial endpoints are toxicity, survival and progression-free survival. DCE-MRI and plasma biomarkers will also be collected to explore their use as tools for treatment individualization in future trials. During the current trial, an indicator of liver function, indocyanine green (ICG), will be used to identify during treatment patients who are at excess risk for radiation-induced liver disease (RILD) so that their radiation dose may be reduced. The model used for individualization will be updated as trial data accrue, so this is an adaptive trial of an individualized therapy. The planned accrual is seventy (70) evaluable patients over three years.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- over age 18
- life expectancy of at least 12 weeks
- Zubrod performance status of ≤2.
- biopsy proven hepatocellular carcinoma (HCC)
- liver metastases
- a discrete hepatic tumor(s) as defined by the Barcelona46 criteria - for cirrhotic patients, (1) 2 imaging studies showing hypervascular tumor > 2cm, or (2) single imaging study showing hypervascular tumor > 2cm with AFP ≥ 400 ng/mL
- a discrete hypervascular tumor present on two consecutive imaging studies (CT or MRI) with documented growth of > 1cm in diameter
- adequate organ function
- women and men not interested in pregnancy
- must be recovered from the effects of any prior surgery, radiation therapy, chemotherapy and the effects of Radiofrequency Ablation (RFA) or Transcatheter Arterial Chemo Embolization (TACE)
- minimum of 6 weeks following their last surgical procedure, radiation and chemotherapy.
Exclusion Criteria:
- cannot be eligible for a curative liver resection
- uncontrolled ascites clinically evident on physical exam
- known allergy to IC-Green
- known allergy to intravenous iodidated contrast agents
- patients with poor venous access
- patients with metastatic cancer with normal liver function who have not undergone previous liver directed therapy and a single tumor < 6 cm in size.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01522937
Contacts
| Contact: Mary Feng, MD | (734) 615-4909 | maryfeng@umich.edu |
| Contact: Cancer AnswerLine | (800) 865-1125 | canceranswerline@umich.edu |
Locations
| United States, Michigan | |
| University of Michigan Comprehensive Cancer Center | Recruiting |
| Ann Arbor, Michigan, United States, 48109-5010 | |
| Contact: Mary Feng, MD 734-615-4909 maryfeng@umich.edu | |
| Contact: Cancer AnswerLine (800) 865-1125 canceranswerline@umich.edu | |
Sponsors and Collaborators
University of Michigan Cancer Center
Investigators
| Principal Investigator: | Mary Feng, MD | University of Michigan Cancer Center |
More Information
No publications provided
| Responsible Party: | University of Michigan Cancer Center |
| ClinicalTrials.gov Identifier: | NCT01522937 History of Changes |
| Other Study ID Numbers: | UMCC 2009-053, HUM00029467 |
| Study First Received: | September 23, 2011 |
| Last Updated: | February 14, 2013 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Liver Neoplasms Carcinoma, Hepatocellular Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases |
Liver Diseases Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type |
ClinicalTrials.gov processed this record on May 23, 2013