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Adult Primary Hepatocellular CarcinomaPhase 2NCT02070419

TACE With or Without Radiation Therapy in Treating Patients With Stage A-C Liver Cancer

A Phase 2 study testing transarterial chemoembolization and stereotactic radiosurgery in people with Adult Primary Hepatocellular Carcinoma and Recurrent Adult Primary Liver Cancer, run by Case Comprehensive Cancer Center.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This randomized phase II trial studies how well transarterial chemoembolization (TACE) works compared with TACE plus radiation therapy in treating patients with end stage liver disease, liver tumors, or potential liver transplant candidates. Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
transarterial chemoembolization and stereotactic radiosurgery
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
Apr 2014to Nov 2014
Phase
Phase 2
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 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • HCC is staged as Barcelona A to C
  • Treatment with SBRT can occur within 6 weeks of registration
  • Eastern Cooperative Oncology Group (ECOG) performance status =< 2
  • Patient has
  • Radiographic enhancing liver lesions with early wash out on triple phase CT or MRI or
  • Histological confirmation of HCC as determined by the Liver Tumor Board
Show all 20Show fewer
  • Hemoglobin greater than 10.0 g/dL
  • Total bilirubin less than 3.0 mg/dL
  • Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) =< 3 X institutional upper limit of normal
  • Alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 3 X institutional upper limit of normal
  • Total aggregate of maximal dimension of liver tumors is =< 8 cm
  • Cirrhotic patients Child Pugh class A or B (score =< 7)
  • Patient must be determined by the treating physician to be medically eligible for liver transplantation measured by imaging modality (magnetic resonance imaging [MRI]/computed tomography [CT] scan) three months post final treatment
  • Absolute neutrophil count >= 1,500/μl
  • Platelet count >= 50,000 μl (after transfusion if required)
  • Life expectancy > 12 weeks
  • Subjects must have the ability to understand and be willing to provide written informed consent
  • Women of child-bearing potential must have a negative pregnancy test within 4 weeks to the start of the SBRT treatment
  • Women must not be pregnant or nursing
  • Sexually active women must agree to use accepted forms of birth control; acceptable options for birth control will be documented in the consent and discussed with the subject prior to enrollment

Who cannot join

  • Patient with previous history of abdominal radiation
  • Cirrhotic patients 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 known cardiac ischemia or stroke within last 6 months
  • Any concurrent medical or psychosocial condition that prohibits a major surgical procedure or immunosuppression that would constitute a contraindication to liver transplantation

About this study

Official title: Trans-Arterial Chemo-Embolization (TACE) vs TACE Plus Stereotactic Body Radio Therapy (SBRT) in the Treatment of Hepatocellular Carcinoma (HCC)

This randomized phase II trial studies how well transarterial chemoembolization (TACE) works compared with TACE plus radiation therapy in treating patients with end stage liver disease, liver tumors, or potential liver transplant candidates. TACE involves reaching up to the blood vessel that feeds the tumor through a catheter placed into the groin vessel. Once the physician has defined the vessel going to the tumor, chemotherapy is infused to the tumor and the vessel is blocked, maintaining the chemotherapy for longer time inside the tumor and stopping the blood flow that feeds the tumor. Stereotactic body radiation therapy (SBRT) is a type of radiation therapy that delivers radiation to the tumor cells but does not harm normal liver cells. It is not yet known whether TACE is more effective with or without SBRT in treating liver tumors.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To determine in patients with stage A to C hepatocellular carcinoma, if stereotactic body radiotherapy after TACE enhanced the response rate of hepatocellular carcinoma (HCC) when compared to TACE alone at 3 months.

SECONDARY OBJECTIVES:

  1. To determine in patients with stage A to C hepatocellular carcinoma, if TACE plus SBRT can achieve a downstaging rate of >= 30% at 3 and 6 months.

II. To determine the rate of grade 3 or 4 adverse events associated with SBRT for liver tumors.

III. To determine the rate of local progression after SBRT. (Based on Response Evaluation Criteria in Solid Tumors [RECIST] criteria) IV. Number of patients who achieve liver transplantation. V. Overall survival.

OUTLINE: Patients are randomized to 1 of 2 treatment arms after the first loco-regional therapy with TACE.

ARM I: Patients undergo TACE according to institutional standard with doxorubicin-eluting beads.

ARM II: Patients undergo TACE as in Arm I and 3 or 5 fractions of SBRT given at least 48 hours apart over 14 days.

After completion of study treatment, patients are followed up at 1, 3, and 6 months and then periodically thereafter.

Being tested
transarterial chemoembolization, stereotactic radiosurgery
Medical subject headings
Carcinoma, Hepatocellular

What participants receive

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

  • transarterial chemoembolizationProcedure or surgery

    Also called TACE

    Undergo TACE with doxorubicin-eluting beads

  • stereotactic radiosurgeryRadiation

    Undergo SBRT

Study groups in NCT02070419
Study groupRoleWhat they receive
Arm I (TACE)Active comparatorPatients undergo (transarterial chemoembolization) TACE according to institutional standard with doxorubicin-eluting beads.
Receives: Procedure: transarterial chemoembolization
Arm II (TACE+SBRT)ExperimentalPatients undergo transarterial chemoembolization (TACE) as in Arm I and 3 or 5 fractions of stereotactic radiosurgery (SBRT) given at least 48 hours apart over 14 days.
Receives: Procedure: transarterial chemoembolization; Radiation: stereotactic radiosurgery

What is being measured

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

  1. Percentage change in gross tumor volume (GTV)

    Percentage of tumor response as defined as change in longest diameter of tumor compared to original tumor length

    Measured: Baseline to 3 months

  2. Difference in mean gross tumor volume (GTV), assessed using the RECIST method

    Difference in mean GTV from T0M and T3M calculated by a student t-test

    Measured: Baseline to 3 months

  3. Difference in tumor grade

    Difference in the grade of tumor (as defined by the RECIST criteria) at T0 and T3 calculated using Chi-square tests.

    Measured: Baseline to 3 months

Secondary outcomes (5)

  1. Rate of downstaging

    Rate of downstaging of stage A to C Hepatocellular Carcinoma using TACE plus SBRT when compared to TACE at 3 and 6 months.

    Measured: Up to 6 months

  2. Grade 3 or 4 adverse events associated with liver tumors

    Number of grade 3 or 4 adverse events associated with SBRT for liver tumors, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events

    Measured: Up to 1 year

  3. Rate of local progression, based on RECIST criteria

    Rate of local disease progression when progression is defined as an estimated increase of > 20% in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since the treatment started or the appearance of one or more new lesions.

    Measured: Up to 6 months

  4. Liver transplant achievement

    Number of patients who achieve liver transplantation

    Measured: Up to 6 months

  5. Survival rate

    The number of days from the first day of treatment on study until death of any cause

    Measured: 1 year

Timeline

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

  1. First posted25 Feb 2014 (estimated)
  2. Study startApr 2014
  3. Primary completionNov 2014
  4. Study completionNov 2014

Why it stopped: Principal Investigator left institution

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02070419
Sponsor's protocol ID
CASE2212
Other IDs
NCI-2014-00246, CASE2212, CASE 2212, P30CA043703
Status last verified
Dec 2014
First submitted
21 Feb 2014
Last updated
2 Dec 2014
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing transarterial chemoembolization and stereotactic radiosurgery in people with Adult Primary Hepatocellular Carcinoma and Recurrent Adult Primary Liver Cancer, run by Case Comprehensive Cancer Center.

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 20 inclusion and 7 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: withdrawn, as of the sponsor's last update on 2 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.

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?

The study was withdrawn before enrolling participants, so there are no results.

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?

Percentage change in gross tumor volume (GTV) (time frame: Baseline to 3 months). The study lists 3 primary outcomes in all. 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 NCT02070419.

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 2 Dec 2014.

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