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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Loma Linda University
Sponsor:
Information provided by (Responsible Party):
Michael Devera, MD, Loma Linda University
ClinicalTrials.gov Identifier:
NCT00857805
First received: March 5, 2009
Last updated: May 29, 2014
Last verified: May 2014
  Purpose

Patients with tumor burden that exceeds Milan criteria are considered to receive one of the following locoregional treatments: transarterial chemoembolization, radiofrequency ablation, percutaneous ethanol injection and proton beam radiation. 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 downstaging, so they can be qualified for liver transplant. 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 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.


Condition Intervention
Carcinoma, Hepatocellular
Procedure: Transarterial Chemoembolization
Radiation: Proton Beam Radiotherapy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial of Transarterial Chemoembolization Versus Proton Beam Radiotherapy for the Treatment of Hepatocellular Carcinoma

Resource links provided by NLM:


Further study details as provided by Loma Linda University:

Primary Outcome Measures:
  • Overall survival [ Time Frame: lifetime ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to progression [ Time Frame: Lifetime ] [ Designated as safety issue: No ]
  • Downstaging [ Time Frame: Lifetime ] [ Designated as safety issue: No ]

Estimated Enrollment: 220
Study Start Date: January 2009
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Transarterial Chemoembolization
Transarterial Chemoembolization
Procedure: Transarterial Chemoembolization
Application of carboplatin, doxorubicin in ethiodol into the artery for one or more sessions.
Other Name: (TACE)
Active Comparator: Proton Beam Radiotherapy
Proton Beam Radiotherapy
Radiation: Proton Beam Radiotherapy
Fifteen consecutive sessions

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00857805

Contacts
Contact: Michael DeVera, MD 909-558-3636 medevera@llu.edu
Contact: Regina Peters 909-558-3672 rpeters@llu.edu

Locations
United States, California
Loma Linda University Medical Center Recruiting
Loma Linda, California, United States, 92354
Sponsors and Collaborators
Loma Linda University
Investigators
Principal Investigator: Michael deVera, MD Loma Linda University Medical Center
  More Information

No publications provided

Responsible Party: Michael Devera, MD, Medical Doctor, Loma Linda University
ClinicalTrials.gov Identifier: NCT00857805     History of Changes
Other Study ID Numbers: 58348
Study First Received: March 5, 2009
Last Updated: May 29, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Loma Linda University:
Transarterial chemoembolization
Carcinoma, Hepatocellular
Proton Beam Radiotherapy

Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Carcinoma
Adenocarcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases

ClinicalTrials.gov processed this record on September 30, 2014