Phase I Study of Proton Beam Irradiation for the Treatment of Unresectable Hepatocellular Cancer or Hepatic Metastases
- 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.
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the maximum tolerated dose (MTD) of proton beam irradiation in patients with unresectable or locally recurrent hepatocellular cancer, cholangiocarcinoma, or hepatic metastases.
Theodore S. Hong, MD
Massachusetts General Hospital
United States: Institutional Review Board