Early Stereotactic Gamma Knife Radiosurgery to Residual Tumor After Surgery of Newly Diagnosed Glioblastoma (Gamma-GBM)
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|ClinicalTrials.gov Identifier: NCT03055208|
Recruitment Status : Recruiting
First Posted : February 16, 2017
Last Update Posted : April 17, 2019
|Condition or disease||Intervention/treatment||Phase|
|Glioblastoma||Radiation: gamma knife radiosurgery (15 Gy to 50% isodose)||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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.
- 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.
- Radiation-related (acute / early delayed / late) neurotoxicity [ Time Frame: 2 years ]Assessed by regular neurological examinations
- Incidence of symptomatic radionecrosis [ Time Frame: 2 years ]Assessed by serial MRI scans
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
|Contact: Frank A. Giordano, MD||+49 621 383 ext firstname.lastname@example.org|
|Department of Radiotherapy University Hospital Mannheim||Recruiting|
|Mannheim, Germany, 68167|
|Contact: Frank A Giordano, MD +49 621 3836020 email@example.com|
|Principal Investigator:||Frank A Giordano, MD||University Medical Center Mannheim|