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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

June 14, 2010
October 1, 2014
June 2010
December 2014   (final data collection date for primary outcome measure)
Local Control Rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]
To demonstrate a 1 year local control rate of greater than 70%
Same as current
Complete list of historical versions of study NCT01239381 on ClinicalTrials.gov Archive Site
  • 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
  • Safety and Tolerance [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    To determine safety and tolerance 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.
  • Local Control [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    To assess the 2-year local control of this treatment program
Not Provided
Not Provided
 
Individualized Stereotactic Body Radiotherapy of Liver Metastases
Phase II Study of Individualized Stereotactic Body Radiotherapy of Liver Metastases

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.

  • 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.
Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Solid Tumor
  • Liver Metastases
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
Experimental: SBRT-Proton
SBRT by proton radiation
Intervention: Radiation: Stereotactic body radiotherapy-proton
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
110
Not Provided
December 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Theodore Hong, MD 617-724-1159 tshong1@partners.org
Contact: Tarin Grillo 617-724-3661 tgrillo@partners.org
United States
 
NCT01239381
10-139, Other
Yes
Theodore Sunki Hong, Massachusetts General Hospital
Massachusetts General Hospital
  • Dana-Farber Cancer Institute
  • Brigham and Women's Hospital
  • National Cancer Institute (NCI)
Principal Investigator: Theodore S. Hong, MD Massachusetts General Hospital
Massachusetts General Hospital
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP