Early Stereotactic Gamma Knife Radiosurgery to Residual Tumor After Surgery of Newly Diagnosed Glioblastoma

Glioblastoma Clinical Trial

— Gamma-GBM  

Official title:

Early Stereotactic Gamma Knife Radiosurgery to Residual Tumor After Surgery of Newly Diagnosed Glioblastoma

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT03055208
• Other study ID #: Gamma-GBM
• Status: Suspended
• Phase: N/A
• Start date: February 8, 2017
• Est. completion date: May 9, 2023

Study information

• Verified date: May 2023
• Source: Universitätsmedizin Mannheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 50
• Est. completion date: May 9, 2023
• Est. primary completion date: March 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glioblastoma
• Neoplasm, Residual

Intervention

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.

Locations

Country	Name	City	State
Germany	Department of Radiotherapy University Hospital Mannheim	Mannheim

Sponsors (1)

Lead Sponsor	Collaborator
Universitätsmedizin Mannheim

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Median Progression-Free Survival Time (PFS)	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.	2 years
Secondary	Median Overall Survival Time (OS)	OS is defined as the time span of initial diagnosis (i.e., the day of surgery) until death by any cause.	2 years
Secondary	Radiation-related (acute / early delayed / late) neurotoxicity	Assessed by regular neurological examinations	2 years
Secondary	Incidence of symptomatic radionecrosis	Assessed by serial MRI scans	2 years