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Dose-staged Gamma Knife Radiosurgery Versus Microsurgical Resection

Primary Purpose

Brain Metastases

Status
Recruiting
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Microsurgical resection
Gamma Knife radiosurgery
Sponsored by
Medical University of Vienna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain Metastases focused on measuring Gamma Knife Radiosurgery, Brain metastases, Microsurgical resection

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients over 18 years and under 90 years
  • Patients with KPS ≥70
  • Patients with NSCLC, melanoma, breast cancer or renal cancer as primary tumor
  • Maximum of three brain metastases on the diagnostic MRI
  • Tumor volume of 8-20 ccm3 on the diagnostic MRI
  • Lobular brain metastases
  • Patients without any contraindications for both treatment options
  • Written, signed informed consent for study particaption after study explanation

Exclusion Criteria:

  • Patients under 18 years and over 90 years
  • Patients with KPS <70
  • Patients with other primary tumor
  • More than three brain metastases on the diagnostic MRI
  • Tumor volume <8 or >20 ccm3 on the diagnostic MRI
  • Patients with contraindications for both treatment options

Sites / Locations

  • Department of Neurosurgery, Medical University of ViennaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Microsurgical Resection of larger Brain Metastasis

Radiosurgery of larger Brain Metastasis

Arm Description

Patients over 18 years and under 90 years Patients with KPS ≥70 Patients with NSCLC, melanoma, breast cancer or renal cancer as primary tumor Maximum of three brain metastases on the diagnostic MRI Tumor volume of 8-20 ccm3 on the diagnostic MRI Lobular brain metastases Patients without any contraindications for both treatment options Written, signed informed consent for study particaption after counseling -> Patients who after counseling decide for microsurgical resection of their brain metastasis

Patients over 18 years and under 90 years Patients with KPS ≥70 Patients with NSCLC, melanoma, breast cancer or renal cancer as primary tumor Maximum of three brain metastases on the diagnostic MRI Tumor volume of 8-20 ccm3 on the diagnostic MRI Lobular brain metastases Patients without any contraindications for both treatment options Written, signed informed consent for study particaption after study counseling -> Patients who after counseling decide for dose-staged radiosurgical treatment of their brain metastasis

Outcomes

Primary Outcome Measures

Overall survival
Time from first treatment

Secondary Outcome Measures

Local tumor progression
Time from first treatment until local tumor progression

Full Information

First Posted
April 15, 2021
Last Updated
April 20, 2021
Sponsor
Medical University of Vienna
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1. Study Identification

Unique Protocol Identification Number
NCT04857905
Brief Title
Dose-staged Gamma Knife Radiosurgery Versus Microsurgical Resection
Official Title
Dose-staged Gamma Knife Radiosurgery Versus Microsurgical Resection - Evaluation of Neurosurgical Treatment Methods for Patients With Larger Brain Metastases - an Explorative Prospective Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2020 (Actual)
Primary Completion Date
July 1, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Vienna

4. Oversight

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

5. Study Description

Brief Summary
Background. Brain metastases (BM) are the most common intracranial tumor and occur in 20-40% of all oncological patients. The most common primary cancer in brain metastases is lung cancer, followed by melanoma, breast cancer, renal cancer and colorectal cancer. The incidence of brain metastases has been increasing but the occurrence of brain metastases is still associated with high morbidity and poor prognosis. The main treatment methods are stereotactic radiosurgery (SRS), microsurgical resection and whole brain irradiation (WBRT). In contrast to microsurgical resection, Gamma Knife radiosurgery (GKRS) is a non-invasive neurosurgical method, which allows treatment in multimorbid patients with contraindications for surgery in general anesthesia. Furthermore, stereotactic radiosurgery is the only local treatment method for multiple disseminated and thereby non-resectable brain metastases. In general, microsurgical resection is considered the treatment of choice for BM exceeding >3 cm in diameter. However, since the establishment of the dose-staged technique, larger metastases can also be treated radiosurgically in selected patients. This novel method allows the application of high cumulative dose for the treatment of complex brain metastases. Aim. The aim of the study is to evaluate the clinical outcome in brain metastases patients with tumor volume between 8 and 20 ccm3. The clinical outcome will be compared between surgically and radiosurgically treated BM patients. Patients and methods. The investigators plan to conduct an explorative prospective study including about 50 radiosurgically and 50 surgically treated patients with brain metastases. If a patient fulfill study-relevant inclusion criteria at the time of BM diagnosis, the principle study investigator will offer both treatment options to the patient. Depending on patient's choice, he/she will be categorized either to surgical or to radiosurgical treatment group. For the outcome evaluation of the different treatment options, a comprehensive database will be established. The study participations will not interfere with any clincally indicated therapeutic decisions and the study participants will not be exposed to any additional risks since both treatments represent suitable therapy options.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Metastases
Keywords
Gamma Knife Radiosurgery, Brain metastases, Microsurgical resection

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Microsurgical Resection of larger Brain Metastasis
Arm Type
Other
Arm Description
Patients over 18 years and under 90 years Patients with KPS ≥70 Patients with NSCLC, melanoma, breast cancer or renal cancer as primary tumor Maximum of three brain metastases on the diagnostic MRI Tumor volume of 8-20 ccm3 on the diagnostic MRI Lobular brain metastases Patients without any contraindications for both treatment options Written, signed informed consent for study particaption after counseling -> Patients who after counseling decide for microsurgical resection of their brain metastasis
Arm Title
Radiosurgery of larger Brain Metastasis
Arm Type
Other
Arm Description
Patients over 18 years and under 90 years Patients with KPS ≥70 Patients with NSCLC, melanoma, breast cancer or renal cancer as primary tumor Maximum of three brain metastases on the diagnostic MRI Tumor volume of 8-20 ccm3 on the diagnostic MRI Lobular brain metastases Patients without any contraindications for both treatment options Written, signed informed consent for study particaption after study counseling -> Patients who after counseling decide for dose-staged radiosurgical treatment of their brain metastasis
Intervention Type
Procedure
Intervention Name(s)
Microsurgical resection
Intervention Description
Depending on the patient's choice, the microsurgical resection of the brain metastases will be performed.
Intervention Type
Procedure
Intervention Name(s)
Gamma Knife radiosurgery
Intervention Description
Depending on the patient's choice, the radiosurgical treatment of the brain metastases will be performed.
Primary Outcome Measure Information:
Title
Overall survival
Description
Time from first treatment
Time Frame
Through completion of the study, an average of 1 year
Secondary Outcome Measure Information:
Title
Local tumor progression
Description
Time from first treatment until local tumor progression
Time Frame
Through completion of the study, an average of half a year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients over 18 years and under 90 years Patients with KPS ≥70 Patients with NSCLC, melanoma, breast cancer or renal cancer as primary tumor Maximum of three brain metastases on the diagnostic MRI Tumor volume of 8-20 ccm3 on the diagnostic MRI Lobular brain metastases Patients without any contraindications for both treatment options Written, signed informed consent for study particaption after study explanation Exclusion Criteria: Patients under 18 years and over 90 years Patients with KPS <70 Patients with other primary tumor More than three brain metastases on the diagnostic MRI Tumor volume <8 or >20 ccm3 on the diagnostic MRI Patients with contraindications for both treatment options
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Josa Frischer, MD, PhD
Phone
+43 1 40400 45510
Email
josa.frischer@meduniwien.ac.at
First Name & Middle Initial & Last Name or Official Title & Degree
Anna Cho, MD
Phone
+43 1 40400 45510
Email
anna.cho@meduniwien.ac.at
Facility Information:
Facility Name
Department of Neurosurgery, Medical University of Vienna
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Josa M Frischer, MD, PhD
Phone
004314040045510
Email
josa.frischer@meduniwien.ac.at
First Name & Middle Initial & Last Name & Degree
Anna Cho, MD
Phone
004314040045510
Email
anna.cho@meduniwien.ac.at
First Name & Middle Initial & Last Name & Degree
Christian Dorfer, MD
First Name & Middle Initial & Last Name & Degree
Karl Rössler, MD
First Name & Middle Initial & Last Name & Degree
Barbara Kiesel, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Dose-staged Gamma Knife Radiosurgery Versus Microsurgical Resection

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