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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
92
Dose will be determined by the size and location of the tumor(s); 2-3 treatments per week for two weeks
Massachusetts General Hospital
Boston, Massachusetts, United States
Dana-Farber Cancer Institue
Boston, Massachusetts, United States
Local Control Rate
The percentage of participants with local control at primary tumor site at one year. Local is evaluated using Response Evaluation Criteria In Solid Tumors (RECIST). Local control is defined as achieving either Complete response (CR), Partial Response (PR), or Stable Disease (SD). * (CR): Disappearance of entire lesion, with no additional evidence of disease. * (PR): At least a 30% decrease in the (sum of) the longest diameter (LD) of the primary lesion, taken as reference the baseline sum LD. * (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.
Time frame: 1 year
Median Follow-up Time
The median follow-up time among the 39 participants still alive at the time of analysis, measured from the start of treatment until the time of analysis.
Time frame: 1 year
Median Overall Survival
The median overall survival (in months) of participants as measured from the start of treatment.
Time frame: 2 years
Median Progression Free Survival
The median amount of time participants survived without cancer progression following the start of study treatment. Progression was assessed using RECIST v1.0. Progressive Disease (PD) is defined as at least a 20% increase in the Longest Diameter (LD) of the lesion, taken as the reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
Time frame: 1 years
2-year Local Control Rate
The percentage of participants with local control 2 years after the start of study treatment.
Time frame: 2 years
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1 Year Local Control Rate Among Participants With Colorectal Cancer
The percentage of participants with local control at one year among the participants with colorectal cancer as the primary cancer.
Time frame: 1 year
Median Survival Among Participants With Colorectal Cancer
The median amount of time participants survived from the start of treatment, among the participants with colorectal cancer.
Time frame: 2 years