Status:
COMPLETED
Proton Beam Irradiation for the Treatment of Unresectable Hepatocellular Cancer or Hepatic Metastases
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
National Cancer Institute (NCI)
Dana-Farber Cancer Institute
Conditions:
Hepatocellular Cancer
Cholangiocarcinoma
Eligibility:
All Genders
18+ years
Phase:
NA
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 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 bea...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2017
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00465023
Start Date
June 1 2003
End Date
January 1 2017
Last Update
January 20 2017
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