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

January 19, 2017 updated by: Theodore Sunki Hong, Massachusetts General Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

16

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
4 years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Collaborators

National Cancer Institute (NCI)
Dana-Farber Cancer Institute
Brigham and Women's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2003

Primary Completion (Actual)

September 1, 2013

Study Completion (Actual)

January 1, 2017

Study Registration Dates

First Submitted

April 23, 2007

First Submitted That Met QC Criteria

April 23, 2007

First Posted (Estimate)

April 24, 2007

Study Record Updates

Last Update Posted (Estimate)

January 20, 2017

Last Update Submitted That Met QC Criteria

January 19, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 03-084

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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