Proton Beam Irradiation for the Treatment of Unresectable Hepatocellular Cancer or Hepatic Metastases
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|ClinicalTrials.gov Identifier: NCT00465023|
Recruitment Status : Completed
First Posted : April 24, 2007
Last Update Posted : January 20, 2017
|Condition or disease||Intervention/treatment||Phase|
|Hepatocellular Cancer Cholangiocarcinoma Hepatic Metastases||Procedure: Proton Beam Radiation||Not Applicable|
- 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 (Clinical Trial)|
|Actual Enrollment :||16 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Study of Proton Beam Irradiation for the Treatment of Unresectable Hepatocellular Cancer or Hepatic Metastases|
|Study Start Date :||June 2003|
|Actual Primary Completion Date :||September 2013|
|Actual Study Completion Date :||January 2017|
Experimental: Proton Beam Radiation
Proton radiation therapy
Procedure: Proton Beam Radiation
Once a day, 5 days a week (Monday-Friday) for 3 weeks.
- 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 ]
- 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.
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
|Principal Investigator:||Theodore S. Hong, MD||Massachusetts General Hospital|