Clinical trial NCT02304445: Chemoembolization With or Without Stereotactic Body Radiosurgery for Liver Cancer
Official title: Trans-Arterial Chemo-Embolization (TACE) Vs. TACE Plus Stereotactic Body Radiosurgery (SBRT) in the Treatment of Hepatocellular Carcinoma (HCC)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Carcinoma, Hepatocellular
Keywords: Radiotherapy
Chemoembolization
Lead sponsor: Midwestern Regional Medical Center
Sponsor class: OTHER
First posted: 2014-12-02
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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-Arterial Chemo-Embolization (TACE) prior to randomization. Subsequently, subjects will be randomized to observation or, if indicated, up to an additional TACE treatments, or to Stereotactic Body Radiotherapy (SBRT). Tumor response following interventions will be evaluated at three months.


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Tumor response rate
timeFrame: 3 months
Secondary outcomes:
measure: Tumor down staging
timeFrame: 3 and 6 months
measure: Frequency of adverse events
timeFrame: 6 months
measure: Incidence of local tumor progression
timeFrame: 6 months
measure: Number of patients eligibility for liver transplantation
timeFrame: 3 months
Other outcomes:
measure: Overall survival
timeFrame: 3 years
Locations:
Study officials:
affiliation: Midwestern Reginal Medical Center
name: Juan Sanabria, MD
role: PRINCIPAL_INVESTIGATOR
References: