Clincosm LogoSign in Get a demo

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

Sponsor
Universitätsmedizin Mannheim (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03055208
Collaborator
(none)
50
Enrollment
1
Location
1
Arm
54.7
Anticipated Duration (Months)
0.9
Patients Per Site Per Month

Study Details

Study Description

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
  • 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
N/A
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 :
Feb 8, 2017
Actual Primary Completion Date :
Mar 30, 2020
Anticipated Study Completion Date :
Sep 1, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Median Progression-Free Survival Time (PFS) [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) [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 [2 years]

    Assessed by regular neurological examinations

  3. Incidence of symptomatic radionecrosis [2 years]

    Assessed by serial MRI scans

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Radiotherapy University Hospital Mannheim Mannheim Germany 68167

Sponsors and Collaborators

  • Universitätsmedizin Mannheim

Investigators

  • Principal Investigator: Frank A Giordano, MD, University Medical Center Mannheim

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
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:
Feb 16, 2017
Last Update Posted:
Apr 28, 2021
Last Verified:
Apr 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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, Interim Head, Department of Radiation Oncology, Universitätsmedizin Mannheim
Glioblastoma
Radiosurgery
Gamma Knife
Additional relevant MeSH terms:
Glioblastoma
Neoplasm, Residual

Study Results

No Results Posted as of Apr 28, 2021