Carcinoma, HepatocellularNCT00857805

Transarterial Chemoembolization Versus Proton Beam Radiotherapy for the Treatment of Hepatocellular Carcinoma

A study testing Transarterial Chemoembolization and Proton Beam Radiotherapy in people with Carcinoma, Hepatocellular, run by Loma Linda University 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

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Carcinoma, Hepatocellular
What is being tested?: Transarterial Chemoembolization and Proton Beam Radiotherapy
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 76 participants
Where: 1 siteUnited States
Study dates: 7 Jan 2009to 7 Jul 2021
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients are candidates to receive both proton beam and TACE
Patients with no evidence of metastasis or macrovascular invasion
Patients with tumor burden that meets San Francisco criteria

Who cannot join

Patients who are candidates for surgical resection
Patients with lesion < 2 cm
Patients who have contraindication to receive either TACE or proton
Patients with serum alpha fetoprotein > 500
Patients with metastasis or macrovascular invasion
Patients treated previously for HCC by any locoregional treatment

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Patients with prior liver transplant
Patients with Child class C
Patients with MELD score of > 25
Patients with other comorbid diseases that may impact survival
Patients with ongoing alcohol intake
Patients with active sepsis
Patients with gastrointestinal bleeding within a week
Patients unwilling to sign informed consent form
Patients with history of noncompliance

Trial locations and contacts

1 site in 1 country.

United States1 site

Loma Linda University Medical Center
Loma Linda, California, 92354

Other trials in United States

About this study

Official title: Randomized Controlled Trial of Transarterial Chemoembolization Versus Proton Beam Radiotherapy for the Treatment of Hepatocellular Carcinoma

Patients with liver tumor burden that exceeds Milan criteria are considered to receive one of the following locoregional treatments: transarterial chemoembolization (TACE), radiofrequency ablation (RFA), percutaneous ethanol injection and proton beam radiation (PBR). The goals of these treatments are to control tumor growth, to downstage tumor size to meet Milan criteria, and to improve survival. Patients who exceed the Milan criteria benefit from tumor downstaging as a result of treatment. Patients who meet Milan criteria benefit from tumor control to bridge them to liver transplantation. TACE is considered the most common locoregional treatment that is used to treat hepatocellular carcinoma (HCC). Proton beam radiotherapy has been used in treating HCC in a few centers across the globe. Phase I and II trials showed a satisfactory safety and efficacy results. Loma Linda University Medical Center is one of these pioneering centers that use proton beam as a treatment for HCC. This is the first randomized trial in the medical field that will compare head-to-head the efficacy of TACE versus proton beam in treating HCC patients.

Conditions: Carcinoma, Hepatocellular
Being tested: Transarterial Chemoembolization, Proton Beam Radiotherapy
Keywords: Transarterial chemoembolization, Carcinoma, Hepatocellular, Proton Beam Radiotherapy
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)
Application of carboplatin, doxorubicin in ethiodol into the artery for one or more sessions.
Proton Beam RadiotherapyRadiation
Fifteen consecutive sessions

Study groups in NCT00857805
Study group	Role	What they receive
Transarterial Chemoembolization	Active comparator	Transarterial Chemoembolization Receives: Procedure: Transarterial Chemoembolization
Proton Beam Radiotherapy	Active comparator	Proton Beam Radiotherapy Receives: Radiation: Proton Beam Radiotherapy

What is being measured

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

Two Year Overall Survival
Comparison between arms of the percentage of patient alive 2 years following study treatment.
Measured: 24 Months

Timeline

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

7 Jan 20097 Jul 2021

First posted9 Mar 2009 (estimated)
Study start7 Jan 2009
Primary completion7 Jul 2021
Study completion7 Jul 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Carcinoma, HepatocellularStudies of the same condition, open and under way.
More trials run by Loma Linda UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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 N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 76 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00857805
Sponsor's protocol ID: 58348
Status last verified: May 2024
First submitted: 5 Mar 2009
Last updated: 31 May 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated device: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Carcinoma, Hepatocellular trials

Study at a glance

From the registry record, last updated by the sponsor on 31 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomized Controlled Trial of Transarterial Chemoembolization Versus Proton Beam Radiotherapy for the Treatment of Hepatocellular Carcinoma
ClinicalTrials.gov ID: NCT00857805
Acronym / sponsor ID: 58348
Conditions: Carcinoma, Hepatocellular
Keywords: Transarterial chemoembolization, Carcinoma, Hepatocellular, Proton Beam Radiotherapy
Study type: Interventional
Recruitment status: Completed
Enrolment: 76 participants (actual)
Lead sponsor: Loma Linda UniversityUniversity, hospital or other
Study start: 7 Jan 2009 (actual)
Primary completion: 7 Jul 2021 (actual)
Study completion: 7 Jul 2021 (actual)
First posted: 9 Mar 2009 (estimated)
Results: Posted 31 May 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Transarterial Chemoembolization	Active comparator	Procedure: Transarterial ChemoembolizationTransarterial Chemoembolization
Proton Beam Radiotherapy	Active comparator	Radiation: Proton Beam RadiotherapyProton Beam Radiotherapy

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Patients are candidates to receive both proton beam and TACE
Patients with no evidence of metastasis or macrovascular invasion
Patients with tumor burden that meets San Francisco criteria

Key exclusion criteria (15 listed)

Patients who are candidates for surgical resection
Patients with lesion < 2 cm
Patients who have contraindication to receive either TACE or proton
Patients with serum alpha fetoprotein > 500
Patients with metastasis or macrovascular invasion

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Transarterial ChemoembolizationAlso: (TACE)Application of carboplatin, doxorubicin in ethiodol into the artery for one or more sessions.	Procedure or surgery	Transarterial Chemoembolization
Proton Beam RadiotherapyFifteen consecutive sessions	Radiation	Proton Beam Radiotherapy

Primary outcome

Two Year Overall Survival
Time frame: 24 Months
Comparison between arms of the percentage of patient alive 2 years following study treatment.

Results and safety

Results posted to the registry on 31 May 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Transarterial Chemoembolization	40	39
Proton Beam Radiotherapy	36	35

Primary outcome: Two Year Overall Survival

Time frame: 24 Months. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Transarterial Chemoembolization n = 39	Proton Beam Radiotherapy n = 35
Value	65 (52 to 83)	68 (54 to 86)

Population analysed: Eligible subjects were adult patients with newly diagnosed and previously untreated HCC. All subjects had characteristic findings of HCC on contrast-enhanced magnetic resonance imaging (MRI) and/or computed tomography (CT) scanning or histologic proof with biopsy. Patients were required to have tumors that were within the Milan or San Francisco criteria, although eligibility for transplant was not required.

Adverse events

Time frame: 30 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Transarterial Chemoembolization	8 of 39 (20.5%)	39 of 39 (100%)	13 of 39
Proton Beam Radiotherapy	2 of 35 (5.7%)	35 of 35 (100%)	16 of 35

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Carcinoma, Hepatocellular

RecruitingObservational study
Real-world Evaluation of the HistoSonics Edison System for Treatment of Liver Tumors Across Multidisciplinary Users (BOOMBOX: Master Study)
Liver Neoplasms, Primary Liver Cancer
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
RecruitingObservational study
A Study to Evaluate Patient-Reported Satisfaction, Effectiveness, and Safety of Atezolizumab in Participants Treated in Routine Clinical Practice
Lung Cancer, Hepatocellular Carcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Michael deVera, MD principal investigator

Loma Linda University Medical Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Transarterial Chemoembolization and Proton Beam Radiotherapy in people with Carcinoma, Hepatocellular, run by Loma Linda University 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 3 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: finished, as of the sponsor's last update on 31 May 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 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 31 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Two Year Overall Survival (time frame: 24 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 NCT00857805.

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 31 May 2024.