Status:
WITHDRAWN
Chemoembolization With or Without Stereotactic Body Radiosurgery for Liver Cancer
Lead Sponsor:
Juan Sanabria, MD
Conditions:
Carcinoma, Hepatocellular
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
This is a randomized, open-label, active comparator-controlled trial of subjects with advanced (Barcelona stage B/C) hepatocellular carcinoma. Subjects will be receive one treatment with Trans-Arteria...
Eligibility Criteria
Inclusion
- Hepatocellular carcinoma (Barcelona Stage B or C)
- Treatment with Stereotactic Body Radiosurgery can occur within 6 weeks of enrollment
- Age ≥ 18 years and ≤ 70 years
- Eastern Cooperative Oncology Group Performance status ≤ 2
- Patient has a) Radiographic enhancing liver lesions with early wash out on triple phase CT or MRI or b) histological confirmation of HCC as determined by the Liver Tumor Board
- Hemoglobin \> 10.0 g/dL
- Total bilirubin \> 3.0 mg/dL
- AST (SGOT) ≤ 3x institutional upper limit of normal
- ALT (SGPT) ≤ 3x institutional upper limit of normal
- Absolute neutrophil count ≥ 1,500/μl
- Platelet count ≥ 50,000/μl (may be post-transfusion if clinically indicated)
- Aggregate maximal dimension of liver tumors ≤ 8 cm
- Cirrhosis classified as Child Pugh Class A or B (score ≤ 7)
- Determined by the treating physician to be medically eligible for liver transplantation measured by imaging modality (MRI/CT scan) three months post final treatment
- Life expectancy ≥ 12 weeks
- Ability to understand study and provide legally effective written informed consent
- Women of child-bearing potential must have a negative test within 4 weeks to the start of the SBRT treatment and must not be pregnant or nursing a child
- Sexually active women must agree to use accepted forms of birth control throughout the study, which include abstinence, oral contraceptives (birth control pills), IUD, diaphragm with spermicide, Norplant, hormone injections, condoms with spermicide, or documentation of medical sterilization
Exclusion
- History of abdominal radiation
- Cirrhosis classified as Child Pugh Class B with score ≥ 8
- 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 registration
- Evidence of main portal vein thrombosis
- History of cardiac ischemia or stroke within 6 months prior to enrollment
- Any concurrent medical or psychosocial condition that prohibits a major surgical procedure or immunosuppressant that would constitute a contraindication to liver transplantation
- History of sorafenib therapy within 21 days prior to enrollment
Key Trial Info
Start Date :
November 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2017
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT02304445
Start Date
November 1 2015
End Date
November 1 2017
Last Update
November 26 2015
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