AzTrials
AzTrials

Recurrent Hepatocellular CarcinomaPhase 3NCT01318200

Transarterial Chemoembolization (TACE) vs. CyberKnife for Recurrent Hepatocellular Carcinoma (HCC)

A Phase 3 study testing Transarterial Chemoembolization and CyberKnife SBRT in people with Recurrent Hepatocellular Carcinoma, run by Accuray Incorporated at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
Search all trials

Trial summary

To compare the efficacy of Transarterial Chemoembolization (TACE) to CyberKnife stereotactic body radiotherapy in the treatment of patients with locally recurrent hepatocellular carcinoma (HCC) after TACE. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Recurrent Hepatocellular Carcinoma
What is being tested?
Transarterial Chemoembolization and CyberKnife SBRT
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
Feb 2011to Feb 2016
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
Show all 19Show fewer
  • 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 contrast liver CT
  • A recent serum AFP must 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 7.5 cm as long as the dose constraints to normal tissue can be met.
  • Eastern Clinical Oncology Group performance status 0, 1 or 2 (Appendix I).
  • Patients with liver disease classified as Child Pugh class A/B, if Child's class B, score must be 8 or less.
  • Life expectancy >= 6 months
  • Age >= 18 years old
  • Albumin >= 2.5 g/dL
  • Total Bilirubin <= 3 mg/dL
  • INR <= 1.5
  • Creatinine <= 2.0 mg/dL
  • Both men and women and members of all races and ethnic groups are eligible for this study
  • 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 tumor
  • Prior radiotherapy to the upper abdomen
  • Prior RFA to index lesion
  • Liver transplant
  • Tumors greater than 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 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 Comprehensive Cancer Center

    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

To compare the efficacy of Transarterial Chemoembolization (TACE) to CyberKnife stereotactic body radiotherapy in the treatment of patients with locally recurrent hepatocellular carcinoma (HCC) after TACE.

Read the detailed description

Hepatocellular carcinoma (HCC) is the third most deadly cancer in the world. It is primarily seen in areas where hepatitis is endemic, such as Asia, but other risk factors include alcoholic cirrhosis.

Surgical resection and/or transplantation remain the only curative options. However, more than 80% of patients present with unresectable disease. For these patients with unresectable tumors, a variety of treatment options are available, including transarterial chemoembolization (TACE), radiofrequency ablation (RFA), radioactive microspheres, microwave coagulation, laser-induced thermotherapy, and percutaneous alcohol injection, all of which have similar survival rates. Stereotactic body radiotherapy (SBRT) for unresectable HCC is a relatively new treatment option made available because of significant improvements in diagnostic imaging and radiation delivery techniques. Although follow-up is limited, results show encouraging local control rates. Some investigators have combined TACE with fractionated conventional radiotherapy as a means of intensifying local therapy, with evidence of efficacy.

TACE remains the dominant mode of local therapy for unresectable HCC. However, recurrence rates are high. Because SBRT is rapidly becoming an accepted local therapy for hepatic lesions, its role in treating HCC needs to be further defined. Moreover, once patients have recurred after initial TACE, it is unclear if additional TACE will be as effective or if another mode of local therapy such as SBRT would be preferable.

We propose to conduct a multicenter randomized study comparing TACE vs. SBRT using CyberKnife for locally recurrent HCC. Locally recurrent HCC will include lesions that persist, progress or recur minimum 3 months after initial TACE.

Being tested
Transarterial Chemoembolization, CyberKnife SBRT
Keywords
Primary liver cancer, Hepatocellular carcinoma, CyberKnife, Accuray, TACE, Transarterial chemoembolization
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

    Transarterial Chemoembolization will be given within 12 weeks and up to 3 staged procedures, depending on the architecture of the tumor vasculature.

  • CyberKnife SBRTRadiation

    Dose is 45 Gy (15 Gy in 3 fractions) or 36 Gy(12 Gy in 3 fractions). Tumors should receive the higher dose unless normal tissue constraints cannot be met.

Study groups in NCT01318200
Study groupRoleWhat they receive
Transarterial ChemoembolizationActive comparatorNot described
Receives: Procedure: Transarterial Chemoembolization
CyberKnife SBRTActive comparatorNot described
Receives: Radiation: CyberKnife SBRT

What is being measured

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

  1. Freedom from local progression

    Freedom from local progression at time T is defined as lack of local progression in the treated liver lesion in the set of patients alive and on study at time T and without distant progression up to time T.

    Measured: 12 months

Secondary outcomes (4)

  1. Progression-free survival

    Progression-free survival will be defined as subject alive and free from local progression, disease recurrence elsewhere in the liver, extrahepatic progression, or clinical deterioration unattributable to another underlying medical condition in the absence of clear radiographic findings of progressive disease.

    Measured: 6, 12 and 18 months

  2. Overall survival

    Overall survival will be determined as a measure of time from diagnosis of initial recurrence until death from any cause.

    Measured: Up to three years following therapy

  3. Serum AFP levels

    Serum AFP levels will be measured at specific points during the study. The 2 endpoints to be analyzed are:

    • Initial AFP levels
    • AFP response - the percent decrease in serum AFP levels from the initial result to the eventual nadir after therapy

    These endpoints will be correlated to the clinical endpoints (freedom from local progression, progression free-survival, and overall survival).

    Measured: 3, 6, 12 and 18 months

  4. Freedom from local progression

    Freedom from local progression at time T is defined as lack of local progression in the treated liver lesion in the set of patients alive and on study at time T and without distant progression up to time T.

    Measured: 6 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 posted18 Mar 2011 (estimated)
  2. Study startFeb 2011
  3. Primary completionFeb 2014 (estimated)
  4. Study completionFeb 2016 (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 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
NCT01318200
Sponsor's protocol ID
ACCH001.0
Status last verified
Feb 2012
First submitted
16 Mar 2011
Last updated
20 Feb 2012
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Transarterial Chemoembolization and CyberKnife SBRT in people with Recurrent Hepatocellular Carcinoma, run by Accuray Incorporated 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 19 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 20 Feb 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 (time frame: 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 NCT01318200.

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 20 Feb 2012.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in