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Proton Beam Irradiation for the Treatment of Unresectable Hepatocellular Cancer and Cholangiocarcinoma

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ClinicalTrials.gov Identifier: NCT00976898
Recruitment Status : Active, not recruiting
First Posted : September 15, 2009
Results First Posted : January 31, 2018
Last Update Posted : January 31, 2018
Sponsor:
Collaborators:
Dana-Farber Cancer Institute
Brigham and Women's Hospital
National Cancer Institute (NCI)
M.D. Anderson Cancer Center
University of Pennsylvania
Information provided by (Responsible Party):
Theodore Sunki Hong, Massachusetts General Hospital

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Liver Cancer
Intervention: Radiation: Proton Beam Irradiation

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Proton Beam Irradiation

This is a single arm study. All study participants will receive proton radiation therapy.

Proton Beam Irradiation: Given once a day, 5 days a week, for 3 weeks


Participant Flow:   Overall Study
    Proton Beam Irradiation
STARTED   83 
COMPLETED   78 
NOT COMPLETED   5 
Protocol Violation                1 
Adverse Event                1 
Physician Decision                1 
Liver Transplant                1 
Progressive Disease                1 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Proton Beam Irradiation

This is a single arm study. All study participants will receive proton radiation therapy.

Proton Beam Irradiation: Given once a day, 5 days a week, for 3 weeks


Baseline Measures
   Proton Beam Irradiation 
Overall Participants Analyzed 
[Units: Participants]
 83 
Age 
[Units: Years]
Median (Full Range)
 67.6 
 (29.9 to 89.7) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      32  38.6% 
Male      51  61.4% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
 
White   76 
Black   4 
Asian   1 
Hispanic (white or black)   1 
Unknown   1 
Region of Enrollment 
[Units: Participants]
 
United States   83 
Underlying Liver Disease 
[Units: Participants]
Count of Participants
 
Hepatitis C Virus (HCV) (± Others)   28 
No HCV but Hepatitis B Virus (HBV) (± Others)   6 
No HCV/HBV but Ethyl Hepatocellularalcohol (EtOH)   8 
No HCV/HBV/EtOH but nonalcoholic steatohepatitis   3 
Other   2 
None   36 
ECOG Performance Status [1] 
[Units: Participants]
Count of Participants
 
 28 
 52 
 3 
[1]

Eastern Cooperative Oncology Group (ECOG) score:

  • 0 – Asymptomatic (Fully active, able to carry on all predisease activities without restriction)
  • 1 – Symptomatic but completely ambulatory (Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature. For example, light housework, office work)
  • 2 – Symptomatic, <50% in bed during the day (Ambulatory and capable of all self care but unable to carry out any work activities. Up and about more than 50% of waking hours)
Child-Turcotte-Pugh Class [1] 
[Units: Participants]
Count of Participants
 
 66 
 15 
 0 
No Cirrhosis   4 
[1] Child-Turcotte-Pugh Class is used to evaluate the prognosis of chronic liver disease (primarily cirrhosis). Classes are determined using 5 clinical measures of liver disease with 1 to 3 points given for each measure, with more points given for less favorable clinical criteria. The 5 measures are total bilirubin, serum albumin, prothrombin time/international normalized ratio (INR), Ascites, and hepatic encephalopathy grade. The classes are A (5-6 points), B (7-9 points), and C (10-15 points) with 'A' having the best survival outcomes and C having the worst.
Disease Status 
[Units: Participants]
Count of Participants
 
Locally Recurrent   5 
Newly Diagnosed   78 
Number of Nodular Tumors 
[Units: Participants]
Count of Participants
 
 66 
 15 
 4 
Previous Therapy 
[Units: Participants]
Count of Participants
 
Any surgical resection   4 
Any transarterial chemoembolization   5 
Any radiofrequency ablation   2 
Any chemotherapy   27 
Any other   15 
None   45 


  Outcome Measures

1.  Primary:   2 Year Local Control Rate   [ Time Frame: 2 years ]

2.  Primary:   Median Overall Survival   [ Time Frame: 5 years ]

3.  Secondary:   Number of Participants With Treatment Related Adverse Events ≥ Grade 3   [ Time Frame: 2 years ]

4.  Secondary:   Patterns of Failure   [ Time Frame: 2 years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Theodore Sunki Hong, MD
Organization: Massachusetts General Hospital
phone: 617-724-1159
e-mail: tshong1@mgh.harvard.edu



Responsible Party: Theodore Sunki Hong, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00976898     History of Changes
Other Study ID Numbers: 09-131
P01CA021239 ( U.S. NIH Grant/Contract )
First Submitted: September 11, 2009
First Posted: September 15, 2009
Results First Submitted: December 7, 2017
Results First Posted: January 31, 2018
Last Update Posted: January 31, 2018