We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00976898
Recruitment Status : Completed
First Posted : September 15, 2009
Results First Posted : January 31, 2018
Last Update Posted : August 15, 2018
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

Brief Summary:
In this study the investigators will be studying the effects of proton beam radiation therapy. This is a very accurate kind of treatment that has been shown to affect less normal tissue than a photon radiation beam. The accuracy allows the investigators to more safely increase the amount of radiation delivered to eliminate cancer. This accuracy will potentially reduce side effects that participants would normally experience using photon radiation therapy. The purpose of this study is to determine if radiation using proton beam therapy will kill the cancer cells in the participants liver.

Condition or disease Intervention/treatment Phase
Liver Cancer Radiation: Proton Beam Irradiation Not Applicable

Detailed Description:
  • 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 83 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Liver Cancer

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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).

  2. 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.

Secondary Outcome Measures :
  1. 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).

  2. 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Biopsy proven unresectable or locally recurrent hepatocellular cancer or intrahepatic cholangiocarcinoma. Patients with a single lesion must be 12cm or less in greatest dimension. For patients with two lesions, no lesion may be greater than 10cm in greatest dimension. For patients with three lesions, no lesion may be greater than 6cm in greatest dimension. Patients may have single or multinodular tumors (up to 3). There must be no evidence of extrahepatic tumor. Portal vein involvement or thrombosis is allowed.
  • Participants must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as 20mm or greater with conventional techniques or as 10mm or greater with spiral CT scan.
  • Patients may have had prior chemotherapy, targeted biological therapy, surgery, transarterial chemoembolization (TACE), radiofrequency ablation, or cryosurgery for their disease as long as it is greater than 4 weeks from first protocol radiation treatment (6 weeks for nitrosoureas or mitomycin C). Patients may not have had prior radiation to the affected area.
  • 18 years of age or older
  • Expected survival must be greater than three months
  • ECOG Performance Status of 0, 1 or 2
  • Normal organ and marrow function as outlined in the protocol
  • If patient has underlying cirrhosis, only Child-Pugh classification Group A or Group B patients should be included in this study.
  • Patients must be either surgically sterile or post-menopausal. Male and female patients of child-bearing potential must agree to use adequate contraception prior to study entry and for the duration of the study participation.
  • Individuals with a history of other malignancies are eligible if they have been disease-free for at least 5 years and are deemed by the investigator to be at low risk for recurrence of that malignancy. Individuals with the following cancers are eligible if diagnosed and treated within the past 5 years: cervical cancer in situ, and basal cell or squamous cell carcinoma of the skin

Exclusion Criteria:

  • Women who are pregnant or lactating
  • Patients with evidence of non-hepatic metastatic disease
  • Local conditions or systemic illnesses which would reduce the local tolerance to radiation treatment, such as serious local injuries, active collagen vascular disease, etc.
  • Prior liver directed radiation treatment
  • Patients may have no serious medical illness, which may limit survival to less than 3 months
  • Patients may have no serious psychiatric illness/social situations which would limit compliance with study requirements
  • Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier
  • Patients may not be receiving any other study agents
  • Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia.

Information from the National Library of Medicine

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): NCT00976898

Layout table for location information
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
Sponsors and Collaborators
Massachusetts General Hospital
Dana-Farber Cancer Institute
Brigham and Women's Hospital
National Cancer Institute (NCI)
M.D. Anderson Cancer Center
University of Pennsylvania
Layout table for investigator information
Principal Investigator: Theodore S. Hong, MD Massachusetts General Hospital
  Study Documents (Full-Text)

Documents provided by Theodore Sunki Hong, Massachusetts General Hospital:
Layout table for additonal information
Responsible Party: Theodore Sunki Hong, Attending Radiation Oncologist, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00976898    
Other Study ID Numbers: 09-131
P01CA021239 ( U.S. NIH Grant/Contract )
First Posted: September 15, 2009    Key Record Dates
Results First Posted: January 31, 2018
Last Update Posted: August 15, 2018
Last Verified: July 2018
Keywords provided by Theodore Sunki Hong, Massachusetts General Hospital:
proton beam radiation
Additional relevant MeSH terms:
Layout table for MeSH terms
Liver Neoplasms
Carcinoma, Hepatocellular
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type