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SBRT for Hepatocellular Carcinoma Patients With Partial Response to TACE

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02221778
Recruitment Status : Active, not recruiting
First Posted : August 20, 2014
Last Update Posted : January 13, 2020
Sponsor:
Information provided by (Responsible Party):
Andre Tsin Chih Chen, University of Sao Paulo

Brief Summary:
This is a pilot study where patients with Hepatocellular Carcinoma (HCC) that have failed Transarterial Chemoembolization (TACE) will be treated with Stereotactic Body Radiation Therapy (SBRT). The focus of the study will be to evaluate safety and efficacy in our population of patients.

Condition or disease Intervention/treatment Phase
Carcinoma, Hepatocellular Radiation: SBRT Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Stereotactic Body Radiation Therapy for Hepatocellular Carcinoma Patients With Partial Response to Transarterial Chemoembolization
Study Start Date : August 2014
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : July 2020

Arm Intervention/treatment
Experimental: SBRT
SBRT according to the intervention description
Radiation: SBRT

SBRT will be prescribed according to the Radiation Therapy Oncology Group (RTOG) 1112 protocol using Mean Liver Dose (MLD) as parameter. MLD will be calculated using Liver minus Gross Tumor Volume (GTV). Prescription dose will follow the scheme below:

Prescription dose(Gy) / (MLD) (Gy)

50 / 13

45 / 15

40 / 15

35 / 15.5

30 / 16

27.5 / 17

If the dose constraints cannot be met, prescription will be according to the level immediately bellow.

Treatment will be delivered in 5 fractions in consecutive working days





Primary Outcome Measures :
  1. Local Progression Free Survival [ Time Frame: 5 years ]

    Local Progression Free Survival will be measured on triphasic Computerized Tomography (CT) or Magnetic Resonance Imaging (MRI) when clinically indicated.

    The exam will be performed every 3 months after the end of treatment. The tumor response will be measured according to the modified RECIST (mRECIST) directed to the HCC study.

    Local Progression Free Survival will be defined as increase of 20% in the sum of all diameters of the treated lesions.

    Time-to-event will be counted from the initiation of SBRT



Secondary Outcome Measures :
  1. Distant Progression Free Survival [ Time Frame: 5 years ]

    Distant Progression Free Survival will be measured on triphasic Computerized Tomography (CT) or Magnetic Resonance Imaging (MRI) when clinically indicated.

    The exam will be performed every 3 months after the end of treatment. The tumor response will be measured according to the modified RECIST (mRECIST) directed to the HCC study.

    Distant Progression Free Survival will be defined as the appearance of a new hepatic lesion, tumoral thrombus or distant metastases.

    Time-to-event will be counted from the initiation of SBRT


  2. Toxicity [ Time Frame: 5 years ]

    Toxicity will be evaluated according to the Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v.4.0). Toxicity will be evaluated weekly during treatment, monthly in the first 3 months after treatment and every 3 months after.

    Acute Toxicity will be defined as toxicity that develops within the first 3 months after initiation treatment.

    Chronic Toxicity will be defined as toxicity that develops after 3 months of initiation of treatment.


  3. Overall Survival [ Time Frame: 5 years ]
    Time-to-event will be counted from the initiation of SBRT



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • HCC diagnosis according to the American Association for the Study of Liver Diseases (AASLD) 2010 criteria
  • Tumor Stage
  • liver only disease
  • tumor thrombus at segment is allowed
  • no extra hepatic metastases
  • tumor encompassing less than 50% of hepatic volume
  • previous treatment with Transarterial Chemo Embolization (TACE) - patient must have performed at least 2 sessions of TACE and have signs of viable tumor in CT or MRI performed 30-40 days after last TACE
  • presence of measurable lesion (at least one lesion that can be measured equal or more than 1 cm in CT or MRI).
  • Maximum lesion size of 10 cm.
  • Liver residual volume equal or more than 700cc or 40% of total liver volume
  • Child-Pugh A or absence of hepatic cirrhosis
  • absence of encephalopathy or ascitis on clinical exam
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1
  • Lab exams:
  • hemoglobin > or equal 8 mg/dl
  • neutrophils > or equal 1.200/mm³
  • platelets > or equal 45.000/mm³
  • alanine aminotransferase (ALT) and aspartate aminotransferase (AST) less than 6 times the upper normal limit
  • bilirubin equal or < 2 mg/dl
  • international normalized ratio (INR) < 1.7
  • serum creatinine equal or < 1.5 times the upper normal limit or creatinine clearance > or equal 60 ml/min
  • Albumin >2.8 mg/dl
  • not being pregnant - a negative pregnancy test is required (for women). Patients in fertile age should use a contraceptive method during treatment and 4 months after.

Exclusion Criteria:

  • Patients with more than 5 discrete lesions in the liver
  • Main or common biliary duct invasion
  • Patients with main portal vein tumor thrombus or more than 2 portal branch thrombus
  • Patients in systemic treatment (sorafenib, chemotherapy). There should be an interval of at least 4 weeks between any medication for treatment of HCC and the current study treatment
  • Previous radiation to upper abdomen
  • Patients with other malignant neoplasms or previous malignant neoplasms will be accepted in the study if HCC prognosis is worse
  • Patients with ischemic myocardial infarction within the last 6 months
  • Patients with large esophageal varices with red color sign or bleeding within the last 3 months
  • Patients with symptoms of colitis, enteritis, esophagitis, fistula, ileus, necrosis, stenosis or ulcer
  • Patients with severe anorexy, constipation, dehydration, diarrhea or vomiting
  • Patients unable to understand and sign written informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02221778


Locations
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Brazil
Instituto do Cancer do Estado de Sao Paulo, Hospital das Clinicas da Faculdade de Medicina da USP
Sao Paulo, Brazil, 01246000
Sponsors and Collaborators
University of Sao Paulo
Investigators
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Study Chair: Flair J Carrilho, MD, PhD University of Sao Paulo
Principal Investigator: Andre T Chen, MD, PhD University of Sao Paulo
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Responsible Party: Andre Tsin Chih Chen, MD, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT02221778    
Other Study ID Numbers: RT-02/2014
First Posted: August 20, 2014    Key Record Dates
Last Update Posted: January 13, 2020
Last Verified: January 2020
Keywords provided by Andre Tsin Chih Chen, University of Sao Paulo:
Carcinoma, Hepatocellular
SBRT
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases