Ignite Creation Date:
2024-05-05 @ 5:30 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00465023
Status:
COMPLETED
Last Update Posted:
2017-01-20
First Post:
2007-04-23
Brief Title:
Proton Beam Irradiation for the Treatment of Unresectable Hepatocellular Cancer or Hepatic Metastases
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
Phase I Study of Proton Beam Irradiation for the Treatment of Unresectable Hepatocellular Cancer or Hepatic Metastases
Status:
COMPLETED
Status Verified Date:
2017-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None