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Fractionated Stereotactic Radiosurgery for Large Brain Metastases

Primary Purpose

Large Brain Mets

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Fractionated Stereotactic Radiosurgery
Sponsored by
Steven Burton
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Large Brain Mets

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UPMC Shadyside Radiation Oncology

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Fractionated Stereotactic Radiosurgery

Arm Description

24 to 36 Gy in 3 fractions (8-12 Gy/fx).

Outcomes

Primary Outcome Measures

Maximum tolerated dose (MTD)
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.

Secondary Outcome Measures

Local control of disease
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.
Regional intracranial failure
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).
Functional Assessment of Cancer Therapy - Brain (FACT-Br)
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.

Full Information

First Posted
January 30, 2014
Last Updated
May 11, 2023
Sponsor
Steven Burton
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1. Study Identification

Unique Protocol Identification Number
NCT02054689
Brief Title
Fractionated Stereotactic Radiosurgery for Large Brain Metastases
Official Title
PHASE I STUDY OF FRACTIONATED STEREOTACTIC RADIOSURGERY FOR LARGE BRAIN METASTASES
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 16, 2013 (Actual)
Primary Completion Date
November 20, 2017 (Actual)
Study Completion Date
April 7, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Steven Burton

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Large Brain Mets

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fractionated Stereotactic Radiosurgery
Arm Type
Other
Arm Description
24 to 36 Gy in 3 fractions (8-12 Gy/fx).
Intervention Type
Radiation
Intervention Name(s)
Fractionated Stereotactic Radiosurgery
Other Intervention Name(s)
SRS, SBRT, CyberKnife, Trilogy, True Beam, Radiosurgery
Intervention Description
SRS SBRT CyberKnife Trilogy True Beam Radiosurgery
Primary Outcome Measure Information:
Title
Maximum tolerated dose (MTD)
Description
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.
Time Frame
Up to 3 years
Secondary Outcome Measure Information:
Title
Local control of disease
Description
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.
Time Frame
Up to 24 months after completion of treatment
Title
Regional intracranial failure
Description
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).
Time Frame
Up to 24 months after completion of treatment
Title
Functional Assessment of Cancer Therapy - Brain (FACT-Br)
Description
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.
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steve Burton, MD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
UPMC Shadyside Radiation Oncology
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Fractionated Stereotactic Radiosurgery for Large Brain Metastases

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