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

Loma Linda University (LLU)

Status: Completed

Conditions: Carcinoma, Hepatocellular

Treatments: Radiation: Proton Beam Radiotherapy; Procedure: Transarterial Chemoembolization

Study type: Interventional

Funder types: Other

Identifiers

NCT00857805

58348

Details and patient eligibility

About

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.

Enrollment: 76 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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76 participants in 2 patient groups

Transarterial Chemoembolization

Active Comparator group

Description:

Transarterial Chemoembolization

Treatment:

Procedure: Transarterial Chemoembolization

Proton Beam Radiotherapy

Active Comparator group

Description:

Proton Beam Radiotherapy

Treatment:

Radiation: Proton Beam Radiotherapy