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Carcinoma, HepatocellularPhase 3NCT01327521

Transarterial Chemoembolization vs CyberKnife for Recurrent Hepatocellular Carcinoma

A Phase 3 study testing CyberKnife, TACE and CT Contrast in people with Carcinoma, Hepatocellular, run by Albert Koong at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

Primary Objective: To compare the efficacy of TACE vs. CyberKnife SBRT in the treatment of locally recurrent HCC after initial TACE. Secondary Objectives: 1. To determine the progression-free survival of TACE vs. CyberKnife SBRT 2. To determine the overall survival of TACE vs. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Carcinoma, Hepatocellular
What is being tested?
CyberKnife, TACE and CT Contrast
How many people
0 participants
Where
1 siteUnited States
Study dates
Feb 2011to Feb 2014
Phase
Phase 3
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

  • Confirmed hepatocellular carcinoma by one of the following:
  • Histopathology
  • One radiographic technique that confirms a lesion >=2 cm with arterial enhancement with washout on delayed phase
  • Hepatic lesion in patients for whom surgical resection is not possible or would not result in an opportunity for cure
  • Radiographic evidence of persistent, progressive or recurrent disease in an area previously treated with TACE. This evaluation should be determined after 6 weeks of initial TACE
  • Multi-specialty evaluation whereby the recurrent liver lesion was deemed by both the attending radiation oncologist and interventional radiologist amenable to treatment by the respective modality
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  • Eligible patients must undergo an IV contrast CT scan of the liver within 6 weeks of enrollment onto the study; a contrast enhanced liver MRI may be substituted for the IV contrast CT of the liver.
  • A recent serum AFP must also be obtained within 4 weeks of enrollment.
  • Unifocal liver tumors not to exceed 7.5 cm in greatest axial dimension. Multifocal lesions will be restricted to lesions that can be treated within a single target volume within the same liver segment and to an aggregate of 7.5cm as long as the dose constraints to normal tissue can be met
  • Eastern Clinical Oncology Group performance status 0, 1 or 2
  • Patients with liver disease classified as Child Pugh class A/B; if Child's class B, score must be 8 or less
  • Albumin >= 2.5 g/dL
  • Total bilirubin <= 3 mg/dL
  • INR <= 1.5
  • Creatinine <= 2.0 mg/dL
  • Age >= 18 years old
  • Life expectancy>= 6 months
  • Ability of the research subject or authorized legal representative to understand and the willingness to sign a written informed consent document.

Who cannot join

  • Prior radiation for the recurrent liver tumors
  • Prior radiotherapy to the upper abdomen
  • Prior RFA to index lesion
  • Liver transplant
  • Tumors >= 7.5 cm in greatest axial dimension
  • Portal vein thrombus
Show all 15Show fewer
  • Large varices within 2 cm of index lesion (seen on cross section imaging)
  • Contraindication to receiving radiotherapy
  • Active gastrointestinal bleed within 2 weeks of study enrollment
  • Ascites refractory to medical therapy
  • Women who are pregnant
  • Administration of any systemic chemotherapy within the last 1 month
  • Presence of multifocal lesions located in different lobes of the liver or extrahepatic metastases
  • Participation in another concurrent SYSTEMIC treatment protocol
  • Prior history of malignancy other than HCC

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Stanford University School of Medicine

    Stanford, California, 94305

Other trials in United States

About this study

Official title: International Randomized Study of Transarterial Chemoembolization Versus CyberKnife for Recurrent Hepatocellular Carcinoma

Primary Objective:

To compare the efficacy of TACE vs. CyberKnife SBRT in the treatment of locally recurrent HCC after initial TACE.

Secondary Objectives:

  1. To determine the progression-free survival of TACE vs. CyberKnife SBRT
  2. To determine the overall survival of TACE vs. CyberKnife SBRT for locally recurrent HCC
  3. To determine the toxicities associated with TACE or CyberKnife SBRT for the treatment of recurrent HCC.
Being tested
CyberKnife, TACE, CT Contrast, doxorubicin, Epirubicin
Medical subject headings
Carcinoma, Hepatocellular

What participants receive

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

  • CyberKnifeDevice

    Also called CK

    Standard of Care

  • TACEProcedure or surgery

    Also called Transcatheter arterial chemoembolization

    Standard of Care

  • CT ContrastDrug

    Also called contrast dye

    Standard of Care

  • doxorubicinDrug

    Also called Adriamycin, hydroxydaunorubicin

    Standard of Care

  • EpirubicinDrug

    Also called Ellence, Pharmorubicin, Epirubicin Ebewe

    Standard of Care

  • 5-fluorouracilDrug

    Also called 5-FU, f5U, Adrucil, Carac

    Standard of Care

  • Mitomycin CDrug

    Also called Mutamycin, MTC

    Standard of Care

  • GemcitabineDrug

    Also called Gemzar

    Standard of Care

  • CisplatinDrug

    Also called cisplatinum, cis-diamminedichloroplatinum(II), CDDP, Platinol

    Standard of Care

  • SMANCSDevice

    Also called styrene maleic acid neocarzinostatin, poppyseed oil

    Standard of Care

What is being measured

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

  1. Freedom from local progression at 6 months and 12 months

    Measured: 6 months and 12 months

Secondary outcomes (3)

  1. Progression-free survival

    Measured: at 6, 12 and 18 months

  2. Overall survival

    Measured: at 6, 12, 18 months and up to 3 years

  3. Serum AFP levels

    Measured: 1 month, 3 months, 6 months, 12 months and 18 months

Timeline

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

  1. First posted1 Apr 2011 (estimated)
  2. Study startFeb 2011
  3. Primary completionFeb 2014 (estimated)

Why it stopped: Accrual below target levels

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01327521
Sponsor's protocol ID
HEP0030
Other IDs
ACCH001.0, SU-05052010-5862
Status last verified
Jun 2012
First submitted
30 Mar 2011
Last updated
11 Jun 2012
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing CyberKnife, TACE and CT Contrast in people with Carcinoma, Hepatocellular, run by Albert Koong 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 18 inclusion and 15 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 11 Jun 2012. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

Freedom from local progression at 6 months and 12 months (time frame: 6 months and 12 months). 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 NCT01327521.

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 11 Jun 2012.

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