- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01194206
Stereotactic Body Radiation Therapy in Liver Cancer That Cannot be Removed by Surgery or Transplant
April 17, 2012 updated by: Case Comprehensive Cancer Center
Downstaging of Hepatocellular Carcinoma by Stereotactic Body Radiotherapy for Non-Resectable and Non-Transplantable Tumors: Phase 2 Study
RATIONALE: Radiation therapy uses high energy x-rays to kill tumor cells.
Stereotactic body radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue in patients with liver cancer.
Giving stereotactic body radiation therapy may also increase patient eligibility for liver transplant.PURPOSE: This phase II trial is studying how well stereotactic body radiation therapy works in treating patients with liver cancer that cannot be removed by surgery or transplant.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Detailed Description
PRIMARY OBJECTIVES:I.
To determine in patients with stage B and C Hepatocellular Carcinoma, if Stereotactic Body Radiotherapy can achieve a downstaging rate of >= 30% at 3 months.SECONDARY OBJECTIVES:I.
To determine in patients with stage B and C Hepatocellular Carcinoma, if Stereotactic Body Radiotherapy can achieve a downstaging rate of >= 30% at 3 and 6 months.II.
To determine the rate of Grade 3 or 4 adverse events associated with SBRT for liver tumors.
III.
To determine the rate of local progression after SBRT.
(Based onRECIST criteria)IV.
To determine the number of patients who achieve liver transplantation.OUTLINE:Patients undergo 3 fractions of stereotactic body radiation therapy delivered within 14 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up periodically for 2 years.
Study Type
Interventional
Phase
- Phase 2
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- HCC is staged as Barcelona B or C (non-resectable and non-transplantable)
- Treatment with SBRT can occur within 6 weeks of staging laparoscopy
- Patient has a) Radiographic enhancing liver lesions on triple phase CT or MRI and b) Histological confirmation of HCC
- Patients with clinical/imaging features of HCC but without biopsy confirmation can be initially enrolled on the protocol and undergo staging laparoscopy for biopsy confirmation with the option of having the fiducials placed in the same procedure; but if the histology is not confirmed and/or other exclusion criteria is met patient will be taken off protocol
- Total aggregate of maximal dimension of liver tumors =< 8 cm
- Cirrhotic patients Child Pugh Class A or B
- Patient should be medically eligible for liver transplantation
- Absolute neutrophil count > 1,500/ul
- Platelets > 50,000 ul (after transfusion if required)
- Hemoglobin greater than 10.0 g/dL
- Total bilirubin < 2.0 mg/dL
- AST(SGOT)/ALT(SGPT) < 2 X institutional upper limit of normal
- Life expectancy > 12 weeks
- ECOG performance status < 2 or Karnofsky >= 70%
- Women of child-bearing potential must have a negative pregnancy test within 4 weeks to the start of the SBRT treatment
- Women must not be pregnant or nursing
- Sexually active men and women must agree to use accepted forms of birth control
- Provision of informed consent: Patient must be able to provide verbal and written informed consent
Exclusion Criteria:
- Patient with previous history of abdominal radiation
- Prior invasive malignancy other than primary liver malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years
- Evidence of metastatic disease prior to staging laparoscopy
- Evidence of main Portal Vein thrombosis
- History of cardiac ischemia or stroke within last 6 months
- Any concurrent medical or psychosocial condition that prohibits a major surgical procedure or immunosuppression that would constitute a contraindication to liver transplantation
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Arm I
Patients undergo 3 fractions of stereotactic body radiation therapy in 3 fractions delivered within 14 days in the absence of disease progression or unacceptable toxicity.
|
At least 3 gold standard Cyberknife fiducials will be placed in the liver w/in 6 cm of the tumor for image guidance during radiation therapy.
At least 1 wk will elapse between fiducial placement and tx planning simulation to allow for fiducial settling and any migration.The full radiation tx will be given ideally in 3 consecutive days.
In any case there must be a minimum of 24 hrs between fractions and all 3 fractions will be delivered w/in 14 days.
The dose to at least 95% of the tumor will be 37.5 Gy total in 12.5 Gy fractions.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Rate of downstaging of stage B and C Hepatocellular Carcinoma using Stereotactic Body Radiotherapy
Time Frame: At 3 months
|
At 3 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Rate of Grade 3 or 4 adverse events associated with SBRT for liver tumors as assessed by NCI CTCAE version 4.0
Time Frame: Baseline, at 1 month, 3 months and 6 months
|
Baseline, at 1 month, 3 months and 6 months
|
Rate of local progression as assessed by RECIST criteria
Time Frame: Baseline, at 1 month, 3 months and 6 months
|
Baseline, at 1 month, 3 months and 6 months
|
Number of patients who achieve liver transplantation
Time Frame: at 6 months after SBRT
|
at 6 months after SBRT
|
Survival rate
Time Frame: Survival will be measured from the first day of treatment on study until death of any cause.
|
Survival will be measured from the first day of treatment on study until death of any cause.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Juan Sanabria, Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2010
Primary Completion (Actual)
March 1, 2012
Study Completion (Actual)
March 1, 2012
Study Registration Dates
First Submitted
September 1, 2010
First Submitted That Met QC Criteria
September 1, 2010
First Posted (Estimate)
September 2, 2010
Study Record Updates
Last Update Posted (Estimate)
April 18, 2012
Last Update Submitted That Met QC Criteria
April 17, 2012
Last Verified
April 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CASE3209
- NCI-2010-01883 (Other Identifier: NCI/CTRP)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Advanced Adult Primary Liver Cancer
-
University of HawaiiGlaxoSmithKlineRecruitingAdvanced Adult Primary Liver Cancer | Localized Unresectable Adult Primary Liver Cancer | Adult Primary Liver CancerUnited States
-
University of CincinnatiActive, not recruitingLiver Metastases | Advanced Adult Primary Liver Cancer | Localized Unresectable Adult Primary Liver Cancer | Recurrent Adult Primary Liver CancerUnited States
-
Vanderbilt-Ingram Cancer CenterNational Cancer Institute (NCI)TerminatedAdvanced Adult Primary Liver Cancer | Localized Resectable Adult Primary Liver Cancer | Localized Unresectable Adult Primary Liver Cancer | Adult Primary Hepatocellular Carcinoma | Stage A Adult Primary Liver Cancer (BCLC) | Stage B Adult Primary Liver Cancer (BCLC)United States
-
University of WashingtonNational Cancer Institute (NCI)CompletedAdvanced Adult Primary Liver Cancer | Localized Resectable Adult Primary Liver Cancer | Localized Unresectable Adult Primary Liver Cancer | Recurrent Adult Primary Liver Cancer | Adult Primary Hepatocellular CarcinomaUnited States
-
National Cancer Institute (NCI)CompletedAdvanced Adult Primary Liver Cancer | Localized Unresectable Adult Primary Liver Cancer | Recurrent Adult Primary Liver Cancer | Adult Primary Hepatocellular CarcinomaUnited States
-
National Cancer Institute (NCI)CompletedAdvanced Adult Primary Liver Cancer | Localized Unresectable Adult Primary Liver Cancer | Recurrent Adult Primary Liver Cancer | Adult Primary Hepatocellular CarcinomaUnited States
-
National Cancer Institute (NCI)CompletedAdvanced Adult Primary Liver Cancer | Localized Unresectable Adult Primary Liver Cancer | Recurrent Adult Primary Liver Cancer | Adult Primary Hepatocellular CarcinomaUnited States, Singapore
-
University of WashingtonNational Cancer Institute (NCI)TerminatedAdvanced Adult Primary Liver Cancer | Localized Unresectable Adult Primary Liver Cancer | Recurrent Adult Primary Liver Cancer | Adult Primary Hepatocellular CarcinomaUnited States
-
National Cancer Institute (NCI)CompletedAdvanced Adult Primary Liver Cancer | Localized Unresectable Adult Primary Liver Cancer | Recurrent Adult Primary Liver Cancer | Adult Primary Hepatocellular CarcinomaUnited States
-
National Cancer Institute (NCI)CompletedAdvanced Adult Primary Liver Cancer | Localized Unresectable Adult Primary Liver Cancer | Recurrent Adult Primary Liver Cancer | Adult Primary Hepatocellular CarcinomaUnited States
Clinical Trials on stereotactic body radiation therapy
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI); Cancer Prevention Research Institute of TexasActive, not recruitingMetastatic Renal Cell Carcinoma | Stage IV Renal Cell Cancer AJCC v8 | Malignant Neoplasms of Urinary Tract | Oligometastatic Renal Cell CarcinomaUnited States
-
Roswell Park Cancer InstituteCompletedLung CancerUnited States
-
University of Texas Southwestern Medical CenterCompletedPain | Unspecified Adult Solid Tumor, Protocol Specific | Metastatic CancerUnited States
-
Radiation Therapy Oncology GroupNational Cancer Institute (NCI); NRG OncologyCompletedLung CancerUnited States, Canada
-
NRG OncologyNational Cancer Institute (NCI)Active, not recruitingStage II Prostate AdenocarcinomaUnited States, Canada, Hong Kong, Switzerland, India, Ireland
-
Barts & The London NHS TrustBarts Cardiovascular CTU (Queen Mary University of London)Not yet recruitingHypertrophic CardiomyopathyUnited Kingdom
-
Erasmus Medical CenterCompletedKlatskin TumorNetherlands
-
Paul W. Read, MDUnknownMetastatic Bone LesionUnited States
-
University of FloridaCompletedSpinal TumorsUnited States
-
RPCR, Inc.CyberKnife CoalitionRecruitingDuctal Carcinoma in Situ | Invasive Ductal Carcinoma of Female BreastUnited States