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

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.

Study Overview

• Status: Completed
• Conditions: Carcinoma, Hepatocellular
• Intervention / Treatment: Procedure: Transarterial Chemoembolization; Radiation: Proton Beam Radiotherapy

• Study Type: Interventional
• Enrollment (Actual): 65
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Loma Linda, California, United States, 92354
      • Loma Linda University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Transarterial Chemoembolization	Procedure: Transarterial Chemoembolization; Application of carboplatin, doxorubicin in ethiodol into the artery for one or more sessions.; Other Names: (TACE)
Active Comparator: Proton Beam Radiotherapy	Radiation: Proton Beam Radiotherapy; Fifteen consecutive sessions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Overall survival	lifetime

Secondary Outcome Measures

Outcome Measure	Time Frame
Time to progression	Lifetime
Downstaging	Lifetime

Collaborators and Investigators

• Sponsor: Loma Linda University
• Investigators: Principal Investigator: Michael deVera, MD, Loma Linda University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): January 7, 2009
• Primary Completion (Actual): July 7, 2021
• Study Completion (Actual): July 7, 2021

Study Registration Dates

• First Submitted: March 5, 2009
• First Submitted That Met QC Criteria: March 5, 2009
• First Posted (Estimate): March 9, 2009

Study Record Updates

• Last Update Posted (Actual): September 27, 2021
• Last Update Submitted That Met QC Criteria: September 21, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Carcinoma, Hepatocellular; Transarterial chemoembolization; Proton Beam Radiotherapy
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Digestive System Neoplasms; Liver Diseases; Liver Neoplasms; Carcinoma; Carcinoma, Hepatocellular
• Other Study ID Numbers: 58348

Drug and device information, study documents

• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes