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Trial record 1 of 1 for: NCT00465023

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

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT00465023

First Posted: April 24, 2007

Last Update Posted: January 20, 2017

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.

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

Purpose

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	Intervention
Hepatocellular Cancer Cholangiocarcinoma Hepatic Metastases	Procedure: Proton Beam Radiation


Study Type:	Interventional
Study Design:	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

Resource links provided by NLM:

Genetics Home Reference related topics: cholangiocarcinoma

MedlinePlus related topics: Liver Cancer

Genetic and Rare Diseases Information Center resources: Bile Duct Cancer

U.S. FDA Resources

Further study details as provided by Theodore Sunki Hong, Massachusetts General Hospital:

Primary Outcome Measures:

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:

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


Enrollment:	16
Study Start Date:	June 2003
Study Completion Date:	January 2017
Primary Completion Date:	September 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Proton Beam Radiation Proton radiation therapy	Procedure: Proton Beam Radiation Once a day, 5 days a week (Monday-Friday) for 3 weeks.

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.

Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
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

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


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 Submitted:	April 23, 2007
First Posted:	April 24, 2007
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 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

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