Comparison of SBRTand Repeat TACE for HCC

Study Overview
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Brief Summary
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Comparison of Stereotactic Body Radiation Therapy (SBRT) and repeated transarterial chemoembolization (TACE) for Hepatocellular Carcinoma (HCC)as a Local Salvage Treatment after first incomplete TACE

Detailed Description
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The aim of this study is to evaluate the effect of SBRT after first incomplete TACE. In HCC patients with incomplete TACE response, repeated TACE did not showed good response. In this case, SBRT could have better results than TACE.

Official Title
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Comparison of Stereotactic Body Radiation Therapy (SBRT)and Repeat Transarterial Chemoembolization (TACE) for Hepatocellular Carcinoma (HCC) as a Local Salvage Treatment After Incomplete TACE : A Prospective Randomized Trial

Conditions
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HepatoCellular Carcinoma

Intervention / Treatment
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* Radiation: SBRT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age >18 years Eastern cooperative oncology group(ECOG) score 0 to 2 Primary HCC HCC (single nodule ≤ 7 cm or max 3 nodules ≤ 3 cm) Child-Turgottei-Pugh A or B Unresectable lesion or medically contraindicated surgery or a case in which surgery was declined. No evidence of radiologically definable major vascular invasion or extrahepatic disease Previously incomplete TACE with radiologically defined residual disease after first TACE Informed consent Exclusion Criteria: Prior TACE to the target lesion Contraindication to receiving radiotherapy or TACE Decompensated liver cirrhosis Extrahepatic mets Pregnancy Patients with other cancers

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SBRT (Stereotatic body radiotherapy)<br>Treatment of SBRT in HCC patients who have incomplete response after first TACE | Radiation: SBRT<br>* Maximum dose : 60Gray (Gy) Fraction : 2 to 5<br>* Other names: Stereotactic Body Radiation Therapy;|
| No Intervention: TACE (Transarterial chemoembolization)<br>Treatment of repeated TACE in HCC patients who have incomplete response after first TACE | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Local tumor control (efficacy fo SBRT) | To evaluate the effect of SBRT. Local tumor control is defined as the disappearance of any intraarterial enhancement in all target lesions. Local tumor control will be measured on triphasic Computerized Tomography (CT) or Magnetic Resonance Imaging (MRI). Patient will be asked to visit their study doctor for follow-up exams and imaging (CT or MRI) every 3 months. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progression free-survival | survival from SBRT to recurrence | 2 year | 
| overall survival | survival from SBRT to death | 2 year | 
| Radiation induced liver disease (RILD) | Liver toxicities were evaluated using Common Terminology Criteria of Adverse Events (CTCAE). RILD was defined as elevated liver transaminases more than five times the upper normal limit or a worsening of Child-Pugh (CP) score by 2 within 3 months after SBRT. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TACE, SBRT