- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02054689
Fractionated Stereotactic Radiosurgery for Large Brain Metastases
May 11, 2023 updated by: Steven Burton
PHASE I STUDY OF FRACTIONATED STEREOTACTIC RADIOSURGERY FOR LARGE BRAIN METASTASES
This is a research trial that seeks to break up the total radiation dose into multiple smaller radiation treatments, termed fractionated stereotactic radiosurgery (FSRS) which may make the treatment feasible.
Fractionated sterotatcic radiation, the risks of FSRS, and possible costs will be described later in this document.
This clinical trial is for people who have had no prior whole brain radiation.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, United States, 15232
- UPMC Shadyside Radiation Oncology
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Male or female patients ≥ 18 years of age
- A life expectancy of at least 12 weeks with a Karnofsky performance status of at least 70 (Appendix II)
- The target lesion(s) can be accurately measured in at least one dimension according to RECIST
- No prior radiotherapy to the brain
- Previous or concurrent systemic or targeted chemotherapy is allowed.
- Patients must have an extra-cranial primary tumor diagnosis
- Patients will have no more than 3 distinct lesions within the brain.
- At least 1 lesion must be a minimum of 3cm in greatest dimension, no larger than 5cm which will be treatable by fractionated stereotactic radiosurgery
- The additional lesions will each be treated with single fraction stereotactic radiosurgery
- Patient may be on steroids or anti-epileptics
- Must be aware of the neoplastic nature of his/her disease and willingly provide written, informed consent after being informed of the procedure to be followed, the experimental nature of the therapy, alternatives, potential benefits, side-effects, risks and discomforts
- Patients do not need a histologically proven diagnosis of brain mets
Exclusion Criteria:
- Symptomatic patients in need of surgery to the "target" lesion
- Four or more newly-diagnosed lesions
- Prior surgical resection of targeted tumor
- Prior WBRT
- Primary brain tumor
- Pregnant or breast-feeding patients
- Primary tumor histology of lymphoma, leukemia, multiple myeloma or germ cell tumor
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Fractionated Stereotactic Radiosurgery
24 to 36 Gy in 3 fractions (8-12 Gy/fx).
|
SRS SBRT CyberKnife Trilogy True Beam Radiosurgery
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maximum tolerated dose (MTD)
Time Frame: Up to 3 years
|
The proportion patients experiencing DLT at each dose; toxicities will be tabulated by category and grade.
The dose-toxicity function, describing the probability of DLT at each dose, will be estimated using logistic regression, along with likelihood ratio profile confidence intervals.
|
Up to 3 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Local control of disease
Time Frame: Up to 24 months after completion of treatment
|
Proportion of patients with local control at each dose.
Local control is defined as stable disease (SD), partial response (PR), or complete response (CR) in the target lesion, per RECIST v1.1.
Complete Response (CR): the disappearance of a target lesion.
Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm., Partial Response (PR): at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Stable Disease (SD): neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study.
|
Up to 24 months after completion of treatment
|
Regional intracranial failure
Time Frame: Up to 24 months after completion of treatment
|
Proportion of patients having local failure (progressive disease (PD)) within the target lesion.
Per RECIST v1.1: Progressive Disease (PD): at least a 20% increase in the sum of diameters of target lesions, taking as a reference the smallest sum on study (this includes the baseline sum if that is the smallest on study).
In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
(Note: the appearance of one or more new lesions is also considered progression).
|
Up to 24 months after completion of treatment
|
Functional Assessment of Cancer Therapy - Brain (FACT-Br)
Time Frame: At 30 days post treatment, 8 -12 weeks post treatment, and at time of each follow-up; Up to 24 months after completion of treatment
|
Functional Assessment of Cancer Therapy - Brain (FACT-Br) is a 50 item, self-administered questionnaire used to assess Quality of Life, including, Physical Well-Being, Social/Family Well-Being, Emotional Well-Being, and Functional Well-Being.
The assessment takes 10-15 minutes to completed and is scored using a 5 point Likert-type scale.
Scores range from 0-250, with higher scores indicating better Quality of Life.
|
At 30 days post treatment, 8 -12 weeks post treatment, and at time of each follow-up; Up to 24 months after completion of treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Steve Burton, MD, University of Pittsburgh
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 16, 2013
Primary Completion (Actual)
November 20, 2017
Study Completion (Anticipated)
April 7, 2024
Study Registration Dates
First Submitted
January 30, 2014
First Submitted That Met QC Criteria
January 31, 2014
First Posted (Estimate)
February 4, 2014
Study Record Updates
Last Update Posted (Actual)
May 15, 2023
Last Update Submitted That Met QC Criteria
May 11, 2023
Last Verified
May 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HCC 11-091
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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