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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Massachusetts General Hospital
Sponsor:
Collaborators:
Dana-Farber Cancer Institute
Brigham and Women's Hospital
M.D. Anderson Cancer Center
University of Pennsylvania
Information provided by (Responsible Party):
Theodore Sunki Hong, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00976898
First received: September 11, 2009
Last updated: April 10, 2014
Last verified: April 2014
  Purpose

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 Intervention Phase
Liver Cancer
Radiation: Proton Beam Irradiation
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Proton Beam Irradiation for the Treatment of Unresectable Hepatocellular Cancer and Cholangiocarcinoma

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • To demonstrate the 2 year LC of >85% with proton beam irradiation for unresectable liver tumors. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • To evaluate 5 year overall survival and local control. [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine safety and tolerance of this treatment program. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • To evaluate tumor response, patterns of failure, and survival in this patient population. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: August 2009
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00976898

Contacts
Contact: Theodore S. Hong, MD 617-724-1159
Contact: Barbara Winrich 617-724-2334 bwinrich@partners.org

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Principal Investigator: Theodore S. Hong, MD         
Dana-Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02115
Principal Investigator: Harvey Mamon, MD, PhD         
United States, Pennsylvania
University of Pennsylvania, Roberts Proton Facility Recruiting
Philadelphia, Pennsylvania, United States
Contact: Edgar Ben-Josef, M.D.    215-662-6567      
Principal Investigator: Edgar Ben-Josef, MD         
United States, Texas
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Christopher H. Crane, MD         
Principal Investigator: Christopher H. Crane, MD         
Sponsors and Collaborators
Massachusetts General Hospital
Dana-Farber Cancer Institute
Brigham and Women's Hospital
M.D. Anderson Cancer Center
University of Pennsylvania
Investigators
Principal Investigator: Theodore S. Hong, MD Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Theodore Sunki Hong, Attending Radiation Oncologist, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00976898     History of Changes
Other Study ID Numbers: 09-131, P01CA021239
Study First Received: September 11, 2009
Last Updated: April 10, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
proton beam radiation

Additional relevant MeSH terms:
Liver Neoplasms
Cholangiocarcinoma
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Liver Diseases
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on July 22, 2014