NCT00614913

Brief Summary

This study is designed to evaluate the possible benefits and side effects of the use of proton therapy for patients with hepatocellular carcinoma.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started May 1998

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 1998

Completed
9.7 years until next milestone

First Submitted

Initial submission to the registry

December 26, 2007

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 13, 2008

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
3.6 years until next milestone

Results Posted

Study results publicly available

August 20, 2012

Completed
Last Updated

August 20, 2012

Status Verified

July 1, 2012

Enrollment Period

10.8 years

First QC Date

December 26, 2007

Results QC Date

June 29, 2011

Last Update Submit

July 16, 2012

Conditions

Liver CancerHepatocellular Carcinoma

Keywords

ProtonRadiotherapyHepatocellular carcinomaLiver Cancer

Outcome Measures

Primary Outcomes (2)

  • 3-year Survival Without Tumor Progression for Patients Within the Milan Criteria

    Percent of participants alive and without tumor progression 3 years following treatment.

    3 months

  • Median Survival Without Tumor Progression

    Median time until disease progression or death

    3 months

Interventions

Proton radiation therapyRADIATION

A total dose of 63 Gy will be delivered in 15 equally divided daily fractions over a 3 week coarse as an out-patient.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of hepatocellular carcinoma
  • Adult patients aged 18 years old and above
  • Ability to give informed consent for study
  • Compensated liver disease

You may not qualify if:

  • Pediatric patients (aged less than 18 years old)
  • Decompensated or advanced liver disease
  • Poorly controlled ascites
  • Variceal hemorrhage within the previous 30 days
  • Recurrent hepatic encephalopathy
  • Cirrhosis with CTP\* score \>10
  • Active alcohol or drug abuse
  • Anticipated survival of less than 30 days
  • Advanced co-morbid medical illnesses
  • Karnofsky Performance Score \<60
  • Tumor characteristics:
  • \- Any tumor that can not be safely and effectively irradiated due to inability to deliver target treatment dose to required treatment volume or due to prohibitively high risk of anticipated toxicities to normal liver or nearby bowel, stomach, kidney or spinal cord.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Loma Linda University Medical Center / James M. Slater Proton Treatment Center

Loma Linda, California, 92354, United States

Location

Related Publications (2)

  • Bush DA, Hillebrand DJ, Slater JM, Slater JD. High-dose proton beam radiotherapy of hepatocellular carcinoma: preliminary results of a phase II trial. Gastroenterology. 2004 Nov;127(5 Suppl 1):S189-93. doi: 10.1053/j.gastro.2004.09.033.

    PMID: 15508084RESULT

  • Bush DA, Kayali Z, Grove R, Slater JD. The safety and efficacy of high-dose proton beam radiotherapy for hepatocellular carcinoma: a phase 2 prospective trial. Cancer. 2011 Jul 1;117(13):3053-9. doi: 10.1002/cncr.25809. Epub 2011 Jan 24.

    PMID: 21264826RESULT

MeSH Terms

Conditions

Liver NeoplasmsCarcinoma, Hepatocellular

Interventions

Protons

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesLiver DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Cations, MonovalentCationsIonsElectrolytesInorganic ChemicalsHydrogenElementsGasesNucleonsElementary ParticlesPhysical Phenomena

Results Point of Contact

Title
David Bush MD
Organization
Radiation Medicine - Loma Linda University Medical Center
dbush@dominion.llumc.edu
909-558-4280

Study Officials

  • David A Bush, MD

    Loma Linda University Dept. of Radiation Medicine

    PRINCIPAL INVESTIGATOR

  • Jerry D Slater, MD

    Loma Linda University Department of Radiation Medicine

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Inverstigator

Study Record Dates

First Submitted

December 26, 2007

First Posted

February 13, 2008

Study Start

May 1, 1998

Primary Completion

February 1, 2009

Study Completion

February 1, 2009

Last Updated

August 20, 2012

Results First Posted

August 20, 2012

Record last verified: 2012-07

Locations

US(1)