ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT00465023
Previous Study | Return to List | Next Study

Proton Beam Irradiation for the Treatment of Unresectable Hepatocellular Cancer or Hepatic Metastases

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00465023
Recruitment Status : Completed
First Posted : April 24, 2007
Last Update Posted : January 20, 2017
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Dana-Farber Cancer Institute
Brigham and Women's Hospital
Information provided by (Responsible Party):
Theodore Sunki Hong, Massachusetts General Hospital

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The main purpose of this study is to determine if high doses of radiation using proton beam can be given safely with low and acceptable side effects. We will also gather information to determine the ability of proton beam to destroy cancer cells in the liver. There are two types of external radiation treatments (proton beam and photon beam). Proton beam radiation is a very accurate kind of treatment that has been shown to affect less normal tissue than a regular radiation beam. The accuracy allows us to more safely increase the amount of radiation delivered to eliminate cancer and may potentially reduce the side effects normally experienced with standard radiation therapy.

Condition or disease Intervention/treatment Phase
Hepatocellular Cancer Cholangiocarcinoma Hepatic Metastases Procedure: Proton Beam Radiation Not Applicable

Detailed Description:
  • Participants will receive treatment as an outpatient at the Northeast Proton Treatment Center located at the Massachusetts General Hospital.
  • Since we are looking for the highest dose of proton beam radiation that can be given to people safely, not everyone who participates in this study will be receiving the same amount of radiation. Small groups of people will be enrolled and given a certain dose of radiation. If they tolerate it well, the next small group of people enrolled will receive a higher dose. This will continue until we find the highest dose that can be given without causing serious or unmanageable side effects.
  • Radiation treatment to the liver will be given once a day, 5 days a week (Monday-Friday), for 3 weeks. Each treatment takes about 10-20 minutes.
  • A physical examination, medical history, and blood tests will be taken once a week for 3 weeks during radiation therapy. Follow-up visits will occur every 3 months for 2 years, and every 6 months thereafter for 3 years, and then annually thereafter.

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Study of Proton Beam Irradiation for the Treatment of Unresectable Hepatocellular Cancer or Hepatic Metastases
Study Start Date : June 2003
Actual Primary Completion Date : September 2013
Actual Study Completion Date : January 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Liver Cancer

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Proton Beam Radiation
Proton radiation therapy
 Procedure: Proton Beam Radiation
Once a day, 5 days a week (Monday-Friday) for 3 weeks.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. To determine the maximum tolerated dose (MTD) of proton beam irradiation in patients with unresectable or locally recurrent hepatocellular cancer, cholangiocarcinoma, or hepatic metastases. [ Time Frame: 4 years ]

Secondary Outcome Measures :
  1. To determine safety and tolerance of this treatment program [ Time Frame: 4 years ]
  2. to evaluate tumor response, local control and survival in this patient population.

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Biopsy proven unresectable or locally recurrent hepatocellular cancer, cholangiocarcinoma, or hepatic metastases.
  • Primary lesion size of 6cm or less in greatest diameter
  • Single or multinodular tumors (up to 3)
  • 18 years of age or older
  • No evidence of extrahepatic tumor
  • Karnofsky performance status of 70-100
  • If patient has underlying cirrhosis, only Child's classification Group A or Group B
  • Adequate renal function
  • Expected survival of greater than three months

Exclusion Criteria:

  • Pregnant or lactating women
  • Evidence of non-hepatic metastatic disease
  • Local conditions or systemic illnesses which would reduce the local tolerance to radiation treatment, such as serious local injuries, active collagen vascular disease, etc.
  • Prior radiation treatment to affected region
  • Serious psychiatric illness which would limit compliance with treatment
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00465023


Sponsors and Collaborators
Massachusetts General Hospital
National Cancer Institute (NCI)
Dana-Farber Cancer Institute
Brigham and Women's Hospital
Investigators
Principal Investigator: Theodore S. Hong, MD Massachusetts General Hospital
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Theodore Sunki Hong, Attending Radiation Oncologist, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00465023     History of Changes
Other Study ID Numbers: 03-084
First Posted: April 24, 2007    Key Record Dates
Last Update Posted: January 20, 2017
Last Verified: January 2017

Keywords provided by Theodore Sunki Hong, Massachusetts General Hospital:
proton beam irradiation
liver cancer

Additional relevant MeSH terms:
Neoplasm Metastasis
Cholangiocarcinoma
Liver Neoplasms
Carcinoma, Hepatocellular
Neoplastic Processes
Neoplasms
Pathologic Processes
Adenocarcinoma
 Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases