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

This study is currently recruiting participants.
Verified June 2011 by Loma Linda University
Sponsor:
Information provided by:
Loma Linda University
ClinicalTrials.gov Identifier:
NCT00857805
First received: March 5, 2009
Last updated: June 1, 2011
Last verified: June 2011
History of Changes
  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:

MedlinePlus related topics: Cancer
U.S. FDA Resources

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 2013
Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Transarterial Chemoembolization
 Procedure: Transarterial Chemoembolization
Application of carboplatin, doxorubicin in ethiodol into the artery for one or more sessions.
Other Name: (TACE)
Active Comparator: 2
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00857805

Contacts
Contact: Zeid Kayali, MD, MBA 909-558-3634 zkayali@llu.edu
Contact: Diane Scavone 909-558-3670 dscavone@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: Zeid Kayali, MD Loma Linda University Medical Center
  More Information

No publications provided

Responsible Party: Zeid Kayali, MD, Loma Linda University Medical Center
ClinicalTrials.gov Identifier: NCT00857805     History of Changes
Other Study ID Numbers: 58348
Study First Received: March 5, 2009
Last Updated: June 1, 2011
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
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
 Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases

ClinicalTrials.gov processed this record on May 16, 2013