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Child-Pugh Class APhase 1NCT02507765

Stereotactic Body Radiation Therapy and Transarterial Chemoembolization in Treating Patients With Liver Cancer That Cannot Be Removed by Surgery

A Phase 1 study testing Laboratory Biomarker Analysis, Stereotactic Body Radiation Therapy and Transarterial Chemoembolization in people with Child-Pugh Class A and Child-Pugh Class B, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This pilot clinical trial studies stereotactic body radiation therapy (SBRT) and transarterial chemoembolization (TACE) in treating patients with liver cancer that cannot be removed by surgery. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Laboratory Biomarker Analysis, Stereotactic Body Radiation Therapy and Transarterial Chemoembolization
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
1 siteUnited States
Study dates
Jul 2015to 5 Jan 2021
Phase
Phase 1
Are there results?
None posted in the registry

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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients must have a diagnosis of hepatocellular carcinoma by at least one criterion listed below:
  • Histologically confirmed
  • Magnetic resonance imaging (MRI) or computerized tomography (CT) findings consistent with hepatocellular carcinoma
  • Alpha fetoprotein (AFP) > 400 ng/mL AND evidence of at least one solid liver lesion > 2 cm regardless of specific imaging characteristics on CT or MRI
  • Patients must be non-transplantable, unresectable, or medically inoperable and eligible for TACE as determined by a multi-disciplinary team
  • Absolute neutrophil count >= 1.5 × 10^9/L
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  • Hemoglobin >= 9 g/dl
  • Platelets >= 50,000/mm^3
  • Prothrombin time (PT)/international normalized ratio (INR) and activated partial thromboplastin time (PTTa) =< 1.5
  • Albumin >= 2.5 g/dL
  • Alkaline phosphatase < 5 x upper limit of normal (ULN)
  • Total bilirubin =< 2.0 mg/dL
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 5 x ULN
  • Creatinine =< 1.5 mg/dL and calculated creatinine clearance >= 60 mL/min or 24-hour urine creatinine clearance >= 60 mL/min
  • Must have Childs-Pugh A or B liver disease
  • Patients must have no clinical signs of heart failure and meet New York Heart Association functional classification I or II defined as:
  • Class I - patients with no limitation of activities; they suffer no symptoms from ordinary activities
  • Class II - patients with slight, mild limitation of activity; they are comfortable with rest or with mild exertion
  • Must have 1-3 liver lesions amenable to SBRT with tumor size < 15 cm (single lesion or sum)
  • Must be able to undergo two MRI scans, one before study treatment begins and another shortly after SBRT
  • Patients with extrahepatic disease, portal hypertension, or bilobar disease are allowed
  • Normal renal function (creatinine < 1.5 mg/dL)
  • Within 2 weeks of registration: patients must have vital signs, history/physical examination, laboratory studies (complete blood count [CBC] with differential, chemistries including liver function tests, AFP, creatinine clearance [CrCl] assessment, pregnancy test if needed)
  • Life expectancy of at least 12 weeks in the opinion of investigator
  • Patient has an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
  • Ability to provide written informed consent obtained prior to participation in the study and any related procedures being performed
  • Women of child-bearing potential (WOCBP) must have a negative pregnancy test within 14 days of the first administration of study treatment; urine human chorionic gonadotropin (HCG) is an acceptable pregnancy assessment
  • Women/men of reproductive potential must be counseled on contraception/abstinence while receiving the study treatment

Who cannot join

  • Childs-Pugh C liver function
  • Major liver vascular invasion
  • Prior radiation to the liver or other upper abdominal regions
  • Must not have any evidence of bleeding diathesis or active gastrointestinal bleeding
  • Any concurrent malignancy other than non-melanoma skin cancer, non-invasive bladder cancer, or carcinoma in situ of the cervix; patients with a previous malignancy without evidence of disease for >= 3 years will be allowed to enter the trial
  • History of active connective tissue disease (scleroderma)
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  • Subjects who are breast-feeding, or have a positive pregnancy test will be excluded from the study; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
  • Medical contraindication to MR imaging (e.g. pacemakers, metallic implants, aneurysm clips, known contrast allergy to gadolinium contrast, pregnancy, nursing mothers, weight greater than 350 pounds)
  • Any serious and/or unstable pre-existing medical disorder (aside from malignancy exception above), psychiatric disorder, or other conditions that could interfere with subject's safety, obtaining informed consent or compliance to the study procedures, in the opinion of the investigator; this could include severe, active co-morbidities such as:
  • Uncontrolled cardiac disease (hypertension, unstable angina, myocardial infarction within last 6 months, uncontrolled congestive heart failure, cardiomyopathy with decreased ejection fraction)
  • Acute bacterial or fungal infection requiring intravenous antibiotics at time of registration
  • Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days of registration
  • Hepatic insufficiency resulting in jaundice and/or coagulation defects

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210

Other trials in United States

About this study

Official title: A Pilot Trial of Stereotactic Body Radiation Therapy (SBRT) to Induce Tumor Hyperemia in Combination With Transarterial Chemoembolization (TACE) for Unresectable Hepatocellular Carcinoma

This pilot clinical trial studies stereotactic body radiation therapy (SBRT) and transarterial chemoembolization (TACE) in treating patients with liver cancer that cannot be removed by surgery. SBRT is a specialized radiation therapy that delivers a high dose of radiation directly to the tumor and may kill more tumor cells and cause less damage to normal tissue. Chemoembolization kills tumor cells by carrying drugs directly into blood vessels near the tumors and then blocking the blood flow to allow a higher concentration of the drug to reach the tumor for a longer period of time. SBRT may make TACE more beneficial by increasing blood flow to the tumor, which may allow more of the TACE chemotherapy to enter the tumor. Giving SBRT with TACE may work better in treating patients with liver cancer that cannot be removed by surgery.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To establish the feasibility of completing SBRT followed by TACE in a 2 day time period.

SECONDARY OBJECTIVES:

  1. To determine acute tumor perfusion changes after SBRT using functional magnetic resonance imaging (MRI) (magnetic resonance [MR]-dynamic contrast enhanced [DCE]/perfusion weighted imaging [PWI], MR-diffusion, blood oxygen level dependent [BOLD] sequences).

II. To establish safety and tolerability of this regimen. III. To determine overall response rates (using modified Response Evaluation Criteria in Solid Tumors [RECIST] criteria), including objective response rate (partial response [PR] + complete response [CR]) and clinical benefit rate (stable disease [SD] + PR + CR) at 1, 3, and 6 months after TACE.

IV. To evaluate local control, progression-free survival, and overall survival at 1, 3, 6, 9, and 12 months after a single-dose of SBRT followed by TACE.

  1. To correlate micro ribonucleic acid (miRNA) biomarkers with response and toxicity.

OUTLINE: This is a dose-escalation study of SBRT.

Patients undergo SBRT on day 1 and TACE on day 2.

After completion of study treatment, patients are followed up at 1-2 weeks and at 1, 3, 6, 9, 12, 18, and 24 months.

Being tested
Laboratory Biomarker Analysis, Stereotactic Body Radiation Therapy, Transarterial Chemoembolization
Keywords
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.

  • Laboratory Biomarker AnalysisOther

    Correlative studies

  • Stereotactic Body Radiation TherapyRadiation

    Also called SBRT

    Undergo SBRT

  • Transarterial ChemoembolizationProcedure or surgery

    Also called TACE

    Undergo TACE

Study groups in NCT02507765
Study groupRoleWhat they receive
Treatment (SBRT, TACE)ExperimentalPatients undergo SBRT on day 1 and TACE on day 2.
Receives: Other: Laboratory Biomarker Analysis; Radiation: Stereotactic Body Radiation Therapy; Procedure: Transarterial Chemoembolization

What is being measured

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

  1. Feasibility of SBRT in combination with TACE, measured by the number of patients able to tolerate all study procedures

    Determined on the intent-to-treat principle. Any treatment delivery difficulties that arise that could impede successful delivery of this therapy sequence will be evaluated. The capability of the Ohio State University (OSU) system and communication between departments will be analyzed and deemed effective if it facilitates the successful treatment completion of all patients.

    Measured: 2 days

Secondary outcomes (8)

  1. Change in diffusion

    Tested by comparing mean values pre- and post-SBRT using a paired t-test. Should there be concern for outliers, the median for each metric will be determined and compared using a corresponding non-parametric procedure.

    Measured: Baseline to day 1 post-SBRT

  2. Change in hypoxia measurements

    Tested by comparing mean values pre- and post-SBRT using a paired t-test. Should there be concern for outliers, the median for each metric will be determined and compared using a corresponding non-parametric procedure.

    Measured: Baseline to day 1 post-SBRT

  3. Change in perfusion

    Tested by comparing mean values pre- and post-SBRT using a paired t-test. Should there be concern for outliers, the median for each metric will be determined and compared using a corresponding non-parametric procedure.

    Measured: Baseline to day 1 post-SBRT

  4. Incidence of toxicities

    Includes measurement of grade 2-5 gastrointestinal symptoms, such as nausea, abdominal pain, hepatitis, enteritis, gastritis, bowel perforation, and fistula, as defined by Common Terminology Criteria for Adverse Events version 4.03.

    Measured: Up to 30 days

  5. Local control

    Calculated using standard clinical follow-up with MRI imaging and labs.

    Measured: Up to 12 months

  6. Objective response rate (CR + PR) as measured by modified RECIST criteria version 1

    Measured: Up to 6 months

  7. Overall survival

    Calculated using standard clinical follow-up with MRI imaging and labs. Estimated using Kaplan-Meier analysis.

    Measured: Up to 12 months

  8. Progression-free survival

    Calculated using standard clinical follow-up with MRI imaging and labs. Estimated using Kaplan-Meier analysis.

    Measured: Up to 12 months

Timeline

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

  1. First posted24 Jul 2015 (estimated)
  2. Study startJul 2015
  3. Primary completion18 Jan 2019
  4. Study completion5 Jan 2021

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 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02507765
Sponsor's protocol ID
OSU-15032
Other IDs
NCI-2015-00894
Status last verified
Oct 2021
First submitted
23 Jul 2015
Last updated
13 Oct 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Sebastian NT, Miller ED, Yang X, Diaz DA, Tan Y, Dowell J, Spain J, Rikabi A, Elliott E, Knopp M, Williams TM. A Pilot Trial Evaluating Stereotactic Body Radiation Therapy to Induce Hyperemia in Combination With Transarterial Chemoembolization for Hepatocellular Carcinoma. Int J Radiat Oncol Biol Phys. 2020 Dec 1;108(5):1276-1283. doi: 10.1016/j.ijrobp.2020.07.033. Epub 2020 Jul 23.

    PubMed 32712254

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Laboratory Biomarker Analysis, Stereotactic Body Radiation Therapy and Transarterial Chemoembolization in people with Child-Pugh Class A and Child-Pugh Class B, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.

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 28 inclusion and 13 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: finished, as of the sponsor's last update on 13 Oct 2021. 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 United States. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Feasibility of SBRT in combination with TACE, measured by the number of patients able to tolerate all study procedures (time frame: 2 days). 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 NCT02507765, 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 13 Oct 2021.

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