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

Carcinoma, Hepatocellular Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00857805
• Other study ID #: 58348
• Status: Completed
• Phase: N/A
• Start date: January 7, 2009
• Est. completion date: July 7, 2021

Study information

• Verified date: May 2024
• Source: Loma Linda University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 (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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: July 7, 2021
• Est. primary completion date: July 7, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular

Intervention

Procedure:
• Transarterial Chemoembolization
Application of carboplatin, doxorubicin in ethiodol into the artery for one or more sessions.

Radiation:
• Proton Beam Radiotherapy
Fifteen consecutive sessions

Locations

Country	Name	City	State
United States	Loma Linda University Medical Center	Loma Linda	California

Sponsors (1)

Lead Sponsor	Collaborator
Loma Linda University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Two Year Overall Survival	Comparison between arms of the percentage of patient alive 2 years following study treatment.	24 Months