Individualized Stereotactic Body Radiotherapy of Liver Metastases

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Massachusetts General Hospital
Sponsor:
Collaborators:
Dana-Farber Cancer Institute
Brigham and Women's Hospital
Information provided by (Responsible Party):
Theodore Sunki Hong, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01239381
First received: June 14, 2010
Last updated: October 1, 2014
Last verified: October 2014
  Purpose

Stereotactic body radiation therapy (SBRT) is a technique that is used to deliver radiation, to sites in the body. All participants in this study will be treated with SBRT using proton beam radiation. Proton beam radiation uses tiny particles to deliver radiation to tumors. The purpose of this research study is to determine if SBRT with protons will prevent tumor growth and reduce the treatment side effects for liver metastases.


Condition Intervention Phase
Solid Tumor
Liver Metastases
Radiation: Stereotactic body radiotherapy-proton
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 Individualized Stereotactic Body Radiotherapy of Liver Metastases

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Local Control Rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    To demonstrate a 1 year local control rate of greater than 70%


Secondary Outcome Measures:
  • Toxicity rate [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    To determine the frequency and severity of treatment related toxicities of this treatment program

  • Dosimetric differences [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    To evaluate the dosimetric differences (prescription dose selected and non-target liver dose) between patients treated with photons and protons.

  • 2-year Local Control Rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    To assess the 2-year local control rate of this treatment program


Estimated Enrollment: 110
Study Start Date: June 2010
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SBRT-Proton
SBRT by proton radiation
Radiation: Stereotactic body radiotherapy-proton
Dose will be determined by the size and location of the tumor(s); 2-3 treatments per week for two weeks

Detailed Description:
  • Participants receiving SBRT with protons, will receive radiation treatment as an outpatient at the Francis H. Burr Proton Therapy Center at Massachusetts General Hospital.
  • Not everyone who participates in this study will be receiving the same dose of radiation. The dose received will be determined by the size and location of the tumor(s).
  • Participants will receive 2-3 SBRT treatments per week for two weeks.
  • During radiation therapy visits the following tests/procedures will be performed: vital signs, physical examination, routine blood tests, research blood tests, and radiation planning.
  • Follow-up assessments will be performed once at 9 weeks after study treatment, then at 6 months, 12 months, 18 months and 24 months after treatment.
  Eligibility

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

Inclusion Criteria:

  • Biopsy-proven cancer diagnosis of a solid tumor with 1-4 liver metastases. There is no upper size limit. Liver metastases may be diagnosed by imaging alone, no liver biopsy is required. Extrahepatic disease is allowed if it have been stable for 3 months prior to study entry, the dominant disease burden is intrahepatic and the patient is referred for definitive radiation therapy to the disease in the liver
  • Measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension 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 the prior therapy occured greater than 3 weeks elapsed before the first radiation treatment. Patients may not have had prior liver directed radiation, including radioembolization.
  • 18 years of age or older
  • Expected survival must be greater than three months
  • ECOG performance status of 0, 1 or 2
  • Patients must have at least 800mL of uninvolved liver
  • Normal organ and marrow function as outlined in the protocol
  • If patient has underlying cirrhosis, only Child-Pugh classification Group A patients should be included in this study. Clinical assessment of ascites and encephalopathy is required. Child-Pugh classification must be determined for all study participants at the time of eligibility analysis.
  • Women of child-bearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation

Exclusion Criteria:

  • Women who are pregnant or lactating
  • Patients with gross ascites or encephalopathy
  • 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, including selective internal radiation
  • No serious medical illness, which may limit survival to less than 3 months
  • No serious psychiatric illness which would limit compliance with treatment
  • Participants who have had chemotherapy or radiotherapy within 3 weeks prior to starting study treatment or those who have not recovered from adverse events due to agents administered more than 3 weeks earlier
  • Participants may not be receiving any other investigational agents, or any other anti-cancer therapy during treatment
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia.
  • Only solid tumors are permitted. Thus, individuals with a liver mass from a diagnosis of lymphoma or leukemia are excluded
  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: NCT01239381

Contacts
Contact: Theodore Hong, MD 617-724-1159 tshong1@partners.org
Contact: Tarin Grillo 617-724-3661 tgrillo@partners.org

Locations
United States, Massachusetts
Dana-Farber Cancer Institue Not yet recruiting
Boston, Massachusetts, United States, 02115
Principal Investigator: Harvey Mamon, MD, PhD         
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Principal Investigator: Theodore Hong, MD         
Sponsors and Collaborators
Massachusetts General Hospital
Dana-Farber Cancer Institute
Brigham and Women's Hospital
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: NCT01239381     History of Changes
Other Study ID Numbers: 10-139, Other
Study First Received: June 14, 2010
Last Updated: October 1, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
proton radiation
stereotactic body radiotherapy
SBRT

Additional relevant MeSH terms:
Liver Neoplasms
Neoplasm Metastasis
Digestive System Diseases
Digestive System Neoplasms
Liver Diseases
Neoplasms
Neoplasms by Site
Neoplastic Processes
Pathologic Processes

ClinicalTrials.gov processed this record on October 20, 2014