Status:
COMPLETED
Transarterial Chemoembolization Versus Proton Beam Radiotherapy for the Treatment of Hepatocellular Carcinoma
Lead Sponsor:
Loma Linda University
Conditions:
Carcinoma, Hepatocellular
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
Patients with liver tumor burden that exceeds Milan criteria are considered to receive one of the following locoregional treatments: transarterial chemoembolization (TACE), radiofrequency ablation (RF...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
- 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
Key Trial Info
Start Date :
January 7 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 7 2021
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT00857805
Start Date
January 7 2009
End Date
July 7 2021
Last Update
May 31 2024
Active Locations (1)
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1
Loma Linda University Medical Center
Loma Linda, California, United States, 92354