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

Study Purpose

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).

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT03055208
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Universitätsmedizin Mannheim
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Frank A Giordano, MD
Principal Investigator Affiliation University Medical Center Mannheim
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Suspended
Countries Germany
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Glioblastoma
Additional Details

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.

Arms & Interventions

Arms

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).

Interventions

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Mannheim, Germany

Status

Address

Department of Radiotherapy University Hospital Mannheim

Mannheim, , 68167

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