Chemoembolization With or Without Stereotactic Body Radiosurgery for Liver Cancer

Carcinoma, Hepatocellular Clinical Trial

— TACE-SBRT  

Official title:

Trans-Arterial Chemo-Embolization (TACE) Vs. TACE Plus Stereotactic Body Radiosurgery (SBRT) in the Treatment of Hepatocellular Carcinoma (HCC)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02304445
• Other study ID #: MZ2014022
• Status: Withdrawn
• Phase: N/A
• First received: November 26, 2014
• Last updated: November 25, 2015
• Start date: November 2015
• Est. completion date: November 2017

Study information

• Verified date: November 2015
• Source: Midwestern Regional Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 2017
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular

Intervention

Procedure:
• Transarterial Chemoembolization (TACE)
TACE is a treatment modality where local delivery of an anti-neoplastic agent is performed through the feeding artery of the tumor followed by end embolization of the artery. The goal of TACE is to cause tumor necrosis and tumor control via acute arterial occlusion while preserving as much functional liver tissue as possible.

Radiation:
• TACE+Stereotactic Body Radiotherapy
This intervention adds Stereotactic Body Radiation (SBRT) to TACE therapy. SBRT is the precise administration of large doses of radiotherapy delivered over 1-5 treatments to extra-cranial tumors.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Juan Sanabria, MD

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Overall survival	Determination of the number of subjects alive at 3 years following their final study treatment.	3 years	No
Primary	Tumor response rate	Tumor Response Rate of stage B or C Hepatocellular Carcinoma using TACE vs. TACE plus SBRT at 3 months	3 months	No
Secondary	Tumor down staging	Incidence of down staging of stage B or C Hepatocellular Carcinoma using TACE plus SBRT when compared to TACE at 3 and 6 months	3 and 6 months	No
Secondary	Frequency of adverse events	Incidence of Grade 3 or 4 adverse events associated with SBRT for liver tumors	6 months	Yes
Secondary	Incidence of local tumor progression	Incidence of local progression as demonstrated by radiological imaging (RECIST criteria)	6 months	No
Secondary	Number of patients eligibility for liver transplantation	Number of patients achieving sufficient tumor response to attain eligibility for liver transplantation.	3 months	No