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A Phase II Study of Pre-Op SRS Followed by Surgical Resection for Brain Metastases

Primary Purpose

Brain Metastases, Adult

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pre-operative Stereotactic Radiosurgery
Sponsored by
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain Metastases, Adult focused on measuring Stereotactic Radiosurgery (SRS)

Eligibility Criteria

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

Inclusion Criteria:

  1. Histologic proof or unequivocal cytologic proof of solid tumor malignancy. This may be obtained from either the primary site or any metastatic site
  2. Solid tumor brain metastases
  3. Age≥ 18 years
  4. Karnofsky Performance Status ≥70
  5. Patient must have agreed to undergo surgical resection to manage at least 1 brain metastasis
  6. Maximum tumor diameter of index lesions <5 cm. (Index lesion defined as the brain metastasis which will undergo surgical resection)
  7. Brain MRI within 1 month of initiation of brain SRS
  8. No prior whole brain radiotherapy (WBRT) or radiation therapy directed to index brain metastases
  9. Patients of childbearing potential (male or female) must practice adequate contraception due to possible harmful effects of radiation therapy on an unborn child
  10. Patient must have the ability to understand and the willingness to sign a written informed consent document
  11. All patients must be informed of the investigational nature of this study and must be given written informed consent in accordance with institutional and federal guidelines
  12. Patients receiving prior SRS for brain metastases in other locations of the brain are eligible
  13. Patients with multiple brain metastases planned for surgical intervention are eligible for this study. Each individual brain metastasis will be treated

Exclusion Criteria:

  1. Prior WBRT or SRS to the index lesion
  2. Brain metastasis greater than or equal to (≤) 5 cm in maximum diameter
  3. Patients must not have a serious medical or psychiatric illness that would in the opinion of the treating physician prevent informed consent or completion of protocol treatment, and/or follow-up visits.
  4. Karnofsky Performance Status (KPS) less than (<)70.
  5. Patients with absolute contraindication to MRI imaging are not eligible for the study
  6. Patients who are pregnant are excluded from the study.

Sites / Locations

  • Allegheny General HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Pre-Operative Stereotactic Radiosurgery (SRS)

Arm Description

Subjects are treated using the standard of care SRS to a total dose of 24-27 Gray (Gy) in 3 fractions with a once daily fractionation or every other day at treating physician discretion. The preferred dose will be 27 Gy, with ability to drop dose down to 24 Gy if normal tissue constraints cannot be met. It should be noted, that while the dosing remains within standard of care, the timing of the radiation (pre-operative) is still not considered standard of care but is supported by emerging data as described in the study background. Additional metastatic lesions may be treated using SRS according to institutional practices. The radiation dose prescribed to the non-index lesions is at the discretion of the treating physicians. Surgical resection will be performed within 2 weeks of completion of SRS.

Outcomes

Primary Outcome Measures

Radiographic Local Control
Radiographic local control at 1 year following completion of pre-operative SRS followed by surgical resection of brain metastasis. Local control will be according to the Response Assessment criteria for Neuro-Oncology (RANO) for brain metastases.

Secondary Outcome Measures

Leptomeningeal disease
MRI will be utilized to evaluate for evidence of leptomeningeal spread at 3 month intervals following preoperative SRS followed by surgical resection of the brain metastasis.
Radio-Necrosis
Pathologic confirmation of radio-necrosis will be recorded as binary variable for each patients as well as the date of surgery confirming radio-necrosis, as applicable.
Pseudo-Progression
Defined as worsening T1 post-gadolinium contrast enhancement and fluid attenuated inversion recovery (FLAIR) changes following SRS which resolve independently without any intervention beyond steroids.

Full Information

First Posted
April 18, 2022
Last Updated
April 18, 2022
Sponsor
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Collaborators
Elekta Limited
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1. Study Identification

Unique Protocol Identification Number
NCT05341739
Brief Title
A Phase II Study of Pre-Op SRS Followed by Surgical Resection for Brain Metastases
Official Title
A Phase II Study of Pre-Operative Stereotactic Radiosurgery Followed by Surgical Resection for Brain Metastases
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 14, 2021 (Actual)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Collaborators
Elekta Limited

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a research study to determine if performing stereotactic radiosurgery (SRS) prior to surgical resection of the brain metastasis (tumor) will improve local control, in other words, increase the possibility of total removal of the primary tumor without local recurrence on longterm follow up. This research study will also determine if pre-operative SRS will lower the risk of radionecrosis that is the breakdown of body tissue at the original tumor site, and the development of leptomeningeal disease.
Detailed Description
Patients with a solid tumor malignancy that has metastasized to the brain are invited to participate in this trial. Upon enrollment to this study a subject will undergo stereotactic radiosurgery (SRS) using the Elekta Gamma Knife Icon, being treated in once daily 15 minute fractions of 9 Gray (Gy) or every other day 15 minute fractions of 9 Gy for a total dose of 27 Gy in 3 doses. A subject will undergo a routine CT and MRI simulation to determine positioning of the head prior to the start of the SRS treatment. Within two (2) weeks after completion of SRS a subject will undergo a routine surgical resection of the brain metastasis. Prior to the SRS treatment and during the follow up phase of the study MRIs will be performed, which are standard of care. Subjects will also complete a quality of life questionnaire. The duration of subject's time participating in this study is 2 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Metastases, Adult
Keywords
Stereotactic Radiosurgery (SRS)

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 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pre-Operative Stereotactic Radiosurgery (SRS)
Arm Type
Experimental
Arm Description
Subjects are treated using the standard of care SRS to a total dose of 24-27 Gray (Gy) in 3 fractions with a once daily fractionation or every other day at treating physician discretion. The preferred dose will be 27 Gy, with ability to drop dose down to 24 Gy if normal tissue constraints cannot be met. It should be noted, that while the dosing remains within standard of care, the timing of the radiation (pre-operative) is still not considered standard of care but is supported by emerging data as described in the study background. Additional metastatic lesions may be treated using SRS according to institutional practices. The radiation dose prescribed to the non-index lesions is at the discretion of the treating physicians. Surgical resection will be performed within 2 weeks of completion of SRS.
Intervention Type
Other
Intervention Name(s)
Pre-operative Stereotactic Radiosurgery
Intervention Description
Pre-operative SRS will be performed prior to the surgical resection of the brain metastases.
Primary Outcome Measure Information:
Title
Radiographic Local Control
Description
Radiographic local control at 1 year following completion of pre-operative SRS followed by surgical resection of brain metastasis. Local control will be according to the Response Assessment criteria for Neuro-Oncology (RANO) for brain metastases.
Time Frame
4-5 Years from first subject enrolled.
Secondary Outcome Measure Information:
Title
Leptomeningeal disease
Description
MRI will be utilized to evaluate for evidence of leptomeningeal spread at 3 month intervals following preoperative SRS followed by surgical resection of the brain metastasis.
Time Frame
4-5 years from first subject enrolled.
Title
Radio-Necrosis
Description
Pathologic confirmation of radio-necrosis will be recorded as binary variable for each patients as well as the date of surgery confirming radio-necrosis, as applicable.
Time Frame
4-5 years from first subject enrolled
Title
Pseudo-Progression
Description
Defined as worsening T1 post-gadolinium contrast enhancement and fluid attenuated inversion recovery (FLAIR) changes following SRS which resolve independently without any intervention beyond steroids.
Time Frame
4-5 years from first subject enrolled

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologic proof or unequivocal cytologic proof of solid tumor malignancy. This may be obtained from either the primary site or any metastatic site Solid tumor brain metastases Age≥ 18 years Karnofsky Performance Status ≥70 Patient must have agreed to undergo surgical resection to manage at least 1 brain metastasis Maximum tumor diameter of index lesions <5 cm. (Index lesion defined as the brain metastasis which will undergo surgical resection) Brain MRI within 1 month of initiation of brain SRS No prior whole brain radiotherapy (WBRT) or radiation therapy directed to index brain metastases Patients of childbearing potential (male or female) must practice adequate contraception due to possible harmful effects of radiation therapy on an unborn child Patient must have the ability to understand and the willingness to sign a written informed consent document All patients must be informed of the investigational nature of this study and must be given written informed consent in accordance with institutional and federal guidelines Patients receiving prior SRS for brain metastases in other locations of the brain are eligible Patients with multiple brain metastases planned for surgical intervention are eligible for this study. Each individual brain metastasis will be treated Exclusion Criteria: Prior WBRT or SRS to the index lesion Brain metastasis greater than or equal to (≤) 5 cm in maximum diameter Patients must not have a serious medical or psychiatric illness that would in the opinion of the treating physician prevent informed consent or completion of protocol treatment, and/or follow-up visits. Karnofsky Performance Status (KPS) less than (<)70. Patients with absolute contraindication to MRI imaging are not eligible for the study Patients who are pregnant are excluded from the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Samantha Campbell
Phone
412-330-6151
Email
samantha.campbell@ahn.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rodney E Wegner, MD
Organizational Affiliation
AHN Radiation Oncology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Allegheny General Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Samantha Campbell
Phone
412-330-6151
Email
samantha.campbell@ahn.org

12. IPD Sharing Statement

Plan to Share IPD
No

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A Phase II Study of Pre-Op SRS Followed by Surgical Resection for Brain Metastases

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