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Early Stereotactic Gamma Knife Radiosurgery to Residual Tumor After Surgery of Newly Diagnosed Glioblastoma (Gamma-GBM)

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: NCT03055208
Recruitment Status : Recruiting
First Posted : February 16, 2017
Last Update Posted : April 17, 2019
Sponsor:
Information provided by (Responsible Party):
Frank A. Giordano, Universitätsmedizin Mannheim

Brief Summary:
Gamma GBM is a single-arm phase II trial that prospectively measures the progression-free survival time after addition of an early gamma knife boost to areas of residual tumor to standard-of-care (surgery, chemo-radiotherapy, chemotherapy).

Condition or disease Intervention/treatment Phase
Glioblastoma Radiation: gamma knife radiosurgery (15 Gy to 50% isodose) Phase 2

Detailed Description:

Glioblastomas are highly malignant brain tumors that recur about 6 months after treatment. Most recurrences develop at the edge of the surgical margin and a common reason for an early recurrence of a glioblastoma is when tumors are not completely resected. This may be the case when intraoperative neuro-monitoring indicates that further resection would impair certain motor functions. Physicians can identify residual tumor in early (24-72h after surgery) postoperative MRI scans and could treat these regions. However, this treatment would not be a part of the recommended standard of care and thus, any further treatment of this areas will need a clinical trial.

The aim of this trial is to evaluate if the use of another modality to deplete these areas of residual tumor identified in early postoperative MRI scans will provide a relevant benefit in terms of progression-free survival (which means a prolongation of the time that patients do not experience a re-growth of the tumor). The modality is termed "radiosurgery", which is a non-invasive technique to delete cells without using a blade but a highly focused beam of gamma rays.

The machine that focusses these rays (like a magnifying glass that can focus light), is called 'gamma knife'. Gamma knife radiosurgery is a safe and effective treatment for a plethora of malignant and benign brain tumors and the technique is used since the 1950s and there has been a continuous improvement of precision and patient comfort up to now.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Early Stereotactic Gamma Knife Radiosurgery to Residual Tumor After Surgery of Newly Diagnosed Glioblastoma
Actual Study Start Date : February 8, 2017
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Radiosurgery

Following intraoperative confirmation of glioblastoma (frozen section):

Early (24-72h post surgery) stereotactic ablation (gamma knife radiosurgery) of residual tumor (defined in early postoperative T1-weighted MRI scanning with and without contrast), followed by standard-of-care therapy (chemo-radiotherapy with 60 Gy external beam radiation therapy (EBRT) and 75 mg/m2/d temozolomide, followed by adjuvant chemotherapy with 150-200 mg/m2/d/cycle temozolomide in a 5/28 days schedule).

Radiation: gamma knife radiosurgery (15 Gy to 50% isodose)
Radiosurgery with a gamma knife resembles the application of a precisely focused, high single dose of ionizing irradiation.




Primary Outcome Measures :
  1. Median Progression-Free Survival Time (PFS) [ Time Frame: 2 years ]
    PFS is defined as the time span of initial diagnosis (i.e., the day of surgery) until tumor progression is confirmed in follow-up MRI scans. All scans will be assessed using modified Response Assessment in Neuro-Oncology (RANO) criteria or until death by any cause.


Secondary Outcome Measures :
  1. Median Overall Survival Time (OS) [ Time Frame: 2 years ]
    OS is defined as the time span of initial diagnosis (i.e., the day of surgery) until death by any cause.

  2. Radiation-related (acute / early delayed / late) neurotoxicity [ Time Frame: 2 years ]
    Assessed by regular neurological examinations

  3. Incidence of symptomatic radionecrosis [ Time Frame: 2 years ]
    Assessed by serial MRI scans



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥ 18
  • Karnofsky performance status score ≥ 60
  • histology must be glioblastoma (frozen sections during surgery)
  • radiographic proof of residual tumor
  • Informed consent
  • adequate birth control (e.g., oral contraceptives)

Exclusion Criteria:

  • any previous cranial radiotherapy
  • histology inconclusive or low(er)-grade astrocytoma
  • contraindications for chemo- or radiotherapy
  • bleeding or clotting disorders
  • contraindications for MRI or CT scans

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): NCT03055208


Contacts
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Contact: Frank A. Giordano, MD +49 621 383 ext 6020 frank.giordano@umm.de

Locations
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Germany
Department of Radiotherapy University Hospital Mannheim Recruiting
Mannheim, Germany, 68167
Contact: Frank A Giordano, MD    +49 621 3836020    frank.giordano@umm.de   
Sponsors and Collaborators
Universitätsmedizin Mannheim
Investigators
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Principal Investigator: Frank A Giordano, MD University Medical Center Mannheim

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Responsible Party: Frank A. Giordano, Interim Head, Department of Radiation Oncology, Universitätsmedizin Mannheim
ClinicalTrials.gov Identifier: NCT03055208    
Other Study ID Numbers: Gamma-GBM
First Posted: February 16, 2017    Key Record Dates
Last Update Posted: April 17, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Frank A. Giordano, Universitätsmedizin Mannheim:
Glioblastoma
Radiosurgery
Gamma Knife
Additional relevant MeSH terms:
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Glioblastoma
Neoplasm, Residual
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplastic Processes
Pathologic Processes