Proton Beam Irradiation for the Treatment of Unresectable Hepatocellular Cancer and Cholangiocarcinoma
|ClinicalTrials.gov Identifier: NCT00976898|
Recruitment Status : Completed
First Posted : September 15, 2009
Results First Posted : January 31, 2018
Last Update Posted : August 15, 2018
|Condition or disease||Intervention/treatment||Phase|
|Liver Cancer||Radiation: Proton Beam Irradiation||Not Applicable|
- Participants will receive treatment as an outpatient in the Francis H. Burr Proton Center at the Massachusetts General Hospital, the MD Anderson Proton Therapy Center or the Roberts Proton Therapy Center at the University of Pennsylvania.
- Not everyone who participates in this study will be receiving the same dose of radiation. The dose received will be determined by the location of the tumor(s) within the liver.
- Proton Beam radiation therapy to the liver will be given once a day, 5 days a week (Monday-Friday), for 2 weeks.
- The following procedures will be performed once a week during treatment on days 1, 8 and 15, as well as on the last day of radiation: physical examination and blood tests.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||83 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Proton Beam Irradiation for the Treatment of Unresectable Hepatocellular Cancer and Cholangiocarcinoma|
|Study Start Date :||August 2009|
|Actual Primary Completion Date :||March 2017|
|Actual Study Completion Date :||July 2018|
Experimental: Proton Beam Irradiation
This is a single arm study. All study participants will receive proton radiation therapy.
Radiation: Proton Beam Irradiation
Given once a day, 5 days a week, for 3 weeks
- 2 Year Local Control Rate [ Time Frame: 2 years ]The percentage of participants with local control after two years as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) 1.0. The duration of control was measured from the start of treatment. Local control is the absence of local failure. Local Failure is defined as evidence of tumor growth/regrowth in any direction beyond that present of the pre-treatment imaging studies in the treated lesion(s).
- Median Overall Survival [ Time Frame: 5 years ]The median survival time in months as measured from the start of treatment until death due to any cause or until the participants is censored. Participants are censored at the date of their last follow-up.
- Number of Participants With Treatment Related Adverse Events ≥ Grade 3 [ Time Frame: 2 years ]Summary of the proton radiation related grade 3 or greater adverse events that participants experienced. Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE v3).
- Patterns of Failure [ Time Frame: 2 years ]A summary of the patterns of treatment failure, shown as the number of participants that fall into each category at the end of study follow-up
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00976898
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|United States, Pennsylvania|
|University of Pennsylvania, Roberts Proton Facility|
|Philadelphia, Pennsylvania, United States|
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Theodore S. Hong, MD||Massachusetts General Hospital|