Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2009-07-31
2015-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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SBRT / TACE
Stereotactic Body Radiation Therapy (SBRT)
The first four patients will receive 50 Gy in 5 fractions (10 Gy /fx) over a 2 week period. The next four patients will be treated to a total dose of 60 Gy in 5 fractions (15 Gy/fx) over two weeks. The final four patients will receive 75 Gy in 5 fractions (15 Gy/fx) delivered over a 2-week period,
Transcatheter Arterial Chemoembolization (TACE)
. Intra-arterial cisplatin treatment will be given at a dose of 125 mg/m2. After delivery of the drug(s) to the tumor, embolization will be accomplished with Embospheres (Biosphere Medical, Inc.,Rockland, MA, USA) until moderate to marked stasis of antegrade flow is seen in the artery.
Interventions
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Stereotactic Body Radiation Therapy (SBRT)
The first four patients will receive 50 Gy in 5 fractions (10 Gy /fx) over a 2 week period. The next four patients will be treated to a total dose of 60 Gy in 5 fractions (15 Gy/fx) over two weeks. The final four patients will receive 75 Gy in 5 fractions (15 Gy/fx) delivered over a 2-week period,
Transcatheter Arterial Chemoembolization (TACE)
. Intra-arterial cisplatin treatment will be given at a dose of 125 mg/m2. After delivery of the drug(s) to the tumor, embolization will be accomplished with Embospheres (Biosphere Medical, Inc.,Rockland, MA, USA) until moderate to marked stasis of antegrade flow is seen in the artery.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. A life expectancy of at least 12 weeks with a Karnofsky performance status of at least 70 (Appendix III)
3. HCC confirmed by biopsy OR diagnosed by clinical and radiologic criteria. All of the following criteria must be met or a biopsy is required: • Known cirrhosis or chronic HBV or HCV infection, • Hypervascular liver masses \>2 cm, and either serum AFP \> 400 ng/ml, or • AFP \>three times normal and doubling in value in the antecedent 3 months.
4. The target lesion(s) can be accurately measured in at least one dimension according to RECIST and must have a combined maximum tumor volume of ≤ 180 cm3.
5. No prior radiotherapy to the liver.
6. Previous systemic chemotherapy or non-radiation local therapy (such as surgery, hepatic arterial therapy, chemoembolization, radiofrequency ablation, percutaneous ethanol injection or cryoablation) is allowed. The lesion must however have shown criteria of progression based on RECIST. Local therapy must be completed at least 4 weeks prior to the baseline scan.
7. Cirrhotic status of Child-Pugh class A or B (Appendix I)
8. Patient's lesions are deemed unresectable.
9. Patient's tumor burden or medical comorbidities disqualify them for transplant OR the patient qualifies for transplant but refuses the operation OR patients planned for TACE as a bridge to transplant operation.
10. Platelet count ≥ 60 x 109/L, Hemoglobin ≥ 8.5 g/dL, WBC ≥ 2000/μL International normalized ratio (INR) ≤ 1.5 or a PT/PTT within normal limits. Patients who are being therapeutically anticoagulated with an agent such as Coumadin or heparin will be allowed to participate provided that no prior evidence of underlying abnormality in these parameters exists.
11. Other baseline labs must meet the following criteria: total bilirubin \<3mg/dl, albumin\>2.5mg/dl, and liver enzymes less than three times the upper limit of normal. Creatinine must also be \<1.8mg/dl or a creatinine clearance \>50ml/min.
12. Must be aware of the neoplastic nature of his/her disease and willingly provide written, informed consent after being informed of the procedure to be followed, the nature of the therapy, alternatives, potential benefits, side-effects, risks and discomforts.
Exclusion Criteria
2. Uncontrolled inter-current illness (except Hepatitis) including, but not limited to ongoing or active infection (\> grade 2 National Cancer Institute \[NCI\]-Common Terminology Criteria for Adverse Events \[CTCAE\] version 3.0), congestive heart failure (\> New York Heart Association (NYHA) class 2), active coronary artery disease (CAD), cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin), uncontrolled hypertension and any condition which could jeopardize the safety of the patient and his/her compliance in the study . Myocardial infarction more than 6 months prior to study entry is permitted.
3. A history of variceal bleeding where the varices have not been eradicated or decompressed by shunt placement.
4. History of an active connective tissue disorder.
5. Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results
6. Pregnant or breast-feeding patients are excluded from this study because abdominal radiation therapy has potential for teratogenic and/or abortifacient effects.
7. Total portal vein occlusion.
8. Extensive liver tumor burden, defined as more than 75% of the liver.
9. Previous or current malignancies of other histologies within the last 5 years, with the exception of cervical carcinoma in situ and adequately treated basal cell or squamous cell carcinoma of the skin.
10. Patients with uncontrolled distant disease will be excluded from this protocol. Those with controlled systemic disease will still be eligible.
18 Years
ALL
No
Sponsors
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University of Pittsburgh
OTHER
Responsible Party
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Dwight Heron
Vice Chairman of Clinical Affairs
Principal Investigators
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Dwight E Heron, MD
Role: STUDY_CHAIR
University of Pittsburgh Medical Center
Locations
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UPMC Presbyterian/Montifore
Pittsburgh, Pennsylvania, United States
Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
UPMC Cancer Pavilion
Pittsburgh, Pennsylvania, United States
UPMC Shadyside Radiation Oncology
Pittsburgh, Pennsylvania, United States
Countries
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Other Identifiers
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08-042
Identifier Type: -
Identifier Source: org_study_id