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

Sponsor

Massachusetts General Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT00465023

Collaborator

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

Enrollment

Arm

163.1

Duration (Months)

Study Details

Study Description

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	N/A

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

Study Type:

Interventional

Actual Enrollment :

16 participants

Allocation:

N/A

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 :

Jun 1, 2003

Actual Primary Completion Date :

Sep 1, 2013

Actual Study Completion Date :

Jan 1, 2017

Arms and Interventions

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.

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

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. [4 years]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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