Transarterial Chemoembolization Versus Proton Beam Radiotherapy for the Treatment of Hepatocellular Carcinoma
| Status: | Recruiting |
|---|---|
| Conditions: | Liver Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - 80 |
| Updated: | 3/8/2017 |
| Start Date: | January 2009 |
| End Date: | January 2018 |
| Contact: | Michael DeVera, MD |
| Email: | medevera@llu.edu |
| Phone: | 909-558-3636 |
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.
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.
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
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Loma Linda University Medical Center An outgrowth of the original Sanitarium on the hill in...
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