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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-07

Study Completion Date

2021-07-07

Brief Summary

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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.

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Detailed Description

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Conditions

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Carcinoma, Hepatocellular

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Transarterial Chemoembolization

Group Type ACTIVE_COMPARATOR

Transarterial Chemoembolization

Intervention Type PROCEDURE

Application of carboplatin, doxorubicin in ethiodol into the artery for one or more sessions.

Proton Beam Radiotherapy

Group Type ACTIVE_COMPARATOR

Proton Beam Radiotherapy

Intervention Type RADIATION

Fifteen consecutive sessions

Interventions

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Transarterial Chemoembolization

Application of carboplatin, doxorubicin in ethiodol into the artery for one or more sessions.

Intervention Type PROCEDURE

Proton Beam Radiotherapy

Fifteen consecutive sessions

Intervention Type RADIATION

Other Intervention Names

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(TACE)

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

1. Patients who are candidates for surgical resection
2. Patients with lesion \< 2 cm
3. Patients who have contraindication to receive either TACE or proton
4. Patients with serum alpha fetoprotein \> 500
5. Patients with metastasis or macrovascular invasion
6. Patients treated previously for HCC by any locoregional treatment
7. Patients with prior liver transplant
8. Patients with Child class C
9. Patients with MELD score of \> 25
10. Patients with other comorbid diseases that may impact survival
11. Patients with ongoing alcohol intake
12. Patients with active sepsis
13. Patients with gastrointestinal bleeding within a week
14. Patients unwilling to sign informed consent form
15. Patients with history of noncompliance

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No