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

NCT00857805 | Completed Results FDA Device

• 1 other identifier: 58348
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

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 (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.

Conditions

Carcinoma, Hepatocellular

Keywords

Transarterial chemoembolization; Carcinoma, Hepatocellular; Proton Beam Radiotherapy

Outcome Measures

Primary Outcomes (1)

• Two Year Overall Survival

  Comparison between arms of the percentage of patient alive 2 years following study treatment.

  24 Months

Study Arms (2)

Transarterial Chemoembolization

ACTIVE COMPARATOR

Transarterial Chemoembolization

Procedure: Transarterial Chemoembolization

Proton Beam Radiotherapy

ACTIVE COMPARATOR

Proton Beam Radiotherapy

Radiation: Proton Beam Radiotherapy

Interventions

Transarterial Chemoembolization PROCEDURE

Application of carboplatin, doxorubicin in ethiodol into the artery for one or more sessions.

Also known as: (TACE)

Transarterial Chemoembolization

Proton Beam Radiotherapy RADIATION

Fifteen consecutive sessions

Proton Beam Radiotherapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Loma Linda University: lead

Study Sites (1)

Loma Linda University Medical Center

Loma Linda, California, 92354, United States

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Chlorotrianisene

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Results Point of Contact

• Title: David Bush, MD, Professor Radiation Medicine
• Organization: Loma Linda University Health

DBush@llu.edu

909 558 1000

Study Officials

• Michael deVera, MD

  Loma Linda University Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: March 5, 2009
• First Posted: March 9, 2009
• Study Start: January 7, 2009
• Primary Completion: July 7, 2021
• Study Completion: July 7, 2021
• Last Updated: May 31, 2024
• Results First Posted: May 31, 2024

Record last verified: 2024-05

Locations

US (1)