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Carcinoma, HepatocellularPhase 2NCT02221778

SBRT for Hepatocellular Carcinoma Patients With Partial Response to TACE

A Phase 2 study testing SBRT in people with Carcinoma, Hepatocellular, run by University of Sao Paulo at 1 site in Brazil.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Carcinoma, Hepatocellular
What is being tested?
SBRT
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
1 siteBrazil
Study dates
Aug 2014to Dec 2024
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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
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  • 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.

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country.

Brazil1 site

  • Instituto do Cancer do Estado de Sao Paulo, Hospital das Clinicas da Faculdade de Medicina da USP

    São Paulo, 01246000

Other trials in Brazil

About this study

Official title: Stereotactic Body Radiation Therapy for Hepatocellular Carcinoma Patients With Partial Response to Transarterial Chemoembolization

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.

Being tested
SBRT
Keywords
Carcinoma, Hepatocellular, SBRT
Medical subject headings
Carcinoma, Hepatocellular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SBRTRadiation

    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

Study groups in NCT02221778
Study groupRoleWhat they receive
SBRTExperimentalSBRT according to the intervention description
Receives: Radiation: SBRT

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Local Progression Free Survival

    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

    Measured: 5 years

Secondary outcomes (3)

  1. Distant Progression Free Survival

    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

    Measured: 5 years

  2. Toxicity

    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.

    Measured: 5 years

  3. Overall Survival

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

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Aug 2014 (estimated)
  2. Study startAug 2014
  3. Primary completionDec 2024 (estimated)
  4. Study completionDec 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
25 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02221778
Sponsor's protocol ID
RT-02/2014
Status last verified
Dec 2024
First submitted
19 Aug 2014
Last updated
6 Dec 2024
Results posted
No
Data monitoring committee
No

Publications

  • Chen ATC, Payao F, Chagas AL, De Souza Melo Alencar RS, Tani CM, da Conceicao Vasconcelos KGM, de Souza Rocha M, de Andrade Carvalho H, Hoff PMG, Carrilho FJ. Feasibility of SBRT for hepatocellular carcinoma in Brazil - a prospective pilot study. Rep Pract Oncol Radiother. 2021 Apr 14;26(2):226-236. doi: 10.5603/RPOR.a2021.0035. eCollection 2021.

    PubMed 34211773

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SBRT in people with Carcinoma, Hepatocellular, run by University of Sao Paulo at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 23 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 6 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Local Progression Free Survival (time frame: 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02221778, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2024.

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