Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Dose-staged Gamma Knife Radiosurgery Versus Microsurgical Resection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04857905
Recruitment Status : Recruiting
First Posted : April 23, 2021
Last Update Posted : April 23, 2021
Sponsor:
Information provided by (Responsible Party):
Josa M Frischer, MD, PhD, Medical University of Vienna

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.


Condition or disease Intervention/treatment Phase
Brain Metastases Procedure: Microsurgical resection Procedure: Gamma Knife radiosurgery Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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
Actual Study Start Date : July 1, 2020
Estimated Primary Completion Date : July 1, 2023
Estimated Study Completion Date : December 1, 2023

Arm Intervention/treatment
Microsurgical Resection of larger 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 counseling

-> Patients who after counseling decide for microsurgical resection of their brain metastasis

Procedure: Microsurgical resection
Depending on the patient's choice, the microsurgical resection of the brain metastases will be performed.

Radiosurgery of larger 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

Procedure: Gamma Knife radiosurgery
Depending on the patient's choice, the radiosurgical treatment of the brain metastases will be performed.




Primary Outcome Measures :
  1. Overall survival [ Time Frame: Through completion of the study, an average of 1 year ]
    Time from first treatment


Secondary Outcome Measures :
  1. Local tumor progression [ Time Frame: Through completion of the study, an average of half a year ]
    Time from first treatment until local tumor progression



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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): NCT04857905


Contacts
Layout table for location contacts
Contact: Josa Frischer, MD, PhD +43 1 40400 45510 josa.frischer@meduniwien.ac.at
Contact: Anna Cho, MD +43 1 40400 45510 anna.cho@meduniwien.ac.at

Locations
Layout table for location information
Austria
Department of Neurosurgery, Medical University of Vienna Recruiting
Vienna, Austria, 1090
Contact: Josa M Frischer, MD, PhD    004314040045510    josa.frischer@meduniwien.ac.at   
Contact: Anna Cho, MD    004314040045510    anna.cho@meduniwien.ac.at   
Principal Investigator: Christian Dorfer, MD         
Sub-Investigator: Karl Rössler, MD         
Sub-Investigator: Barbara Kiesel, MD         
Sponsors and Collaborators
Medical University of Vienna
Layout table for additonal information
Responsible Party: Josa M Frischer, MD, PhD, Principal Investigator, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT04857905    
Other Study ID Numbers: EK 1623/2020
First Posted: April 23, 2021    Key Record Dates
Last Update Posted: April 23, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Josa M Frischer, MD, PhD, Medical University of Vienna:
Gamma Knife Radiosurgery
Brain metastases
Microsurgical resection
Additional relevant MeSH terms:
Layout table for MeSH terms
Neoplasm Metastasis
Brain Neoplasms
Neoplastic Processes
Neoplasms
Pathologic Processes
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases