Individualized Stereotactic Body Radiotherapy of Liver Metastases
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|ClinicalTrials.gov Identifier: NCT01239381|
Recruitment Status : Completed
First Posted : November 11, 2010
Results First Posted : July 13, 2017
Last Update Posted : November 6, 2017
|Condition or disease||Intervention/treatment||Phase|
|Solid Tumor Liver Metastases||Radiation: Stereotactic body radiotherapy-proton||Not Applicable|
- 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 (Clinical Trial)|
|Actual Enrollment :||92 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Individualized Stereotactic Body Radiotherapy of Liver Metastases|
|Study Start Date :||June 2010|
|Actual Primary Completion Date :||January 2016|
|Actual Study Completion Date :||September 2017|
Stereotactic body radiotherapy 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
- Local Control Rate [ Time Frame: 1 year ]
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.
- Median Follow-up Time [ Time Frame: 1 year ]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.
- Median Overall Survival [ Time Frame: 2 years ]The median overall survival (in months) of participants as measured from the start of treatment.
- Median Progression Free Survival [ Time Frame: 1 years ]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.
- 2-year Local Control Rate [ Time Frame: 2 years ]The percentage of participants with local control 2 years after the start of study treatment.
- 1 Year Local Control Rate Among Participants With Colorectal Cancer [ Time Frame: 1 year ]The percentage of participants with local control at one year among the participants with colorectal cancer as the primary cancer.
- Median Survival Among Participants With Colorectal Cancer [ Time Frame: 2 years ]The median amount of time participants survived from the start of treatment, among the participants with colorectal cancer.
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): NCT01239381
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Dana-Farber Cancer Institue|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Theodore S. Hong, MD||Massachusetts General Hospital|