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

NCT03055208 | Suspended

• 1 other identifier: Gamma-GBM
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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).

Conditions

Glioblastoma

Keywords

Glioblastoma; Radiosurgery; Gamma Knife

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Median Overall Survival Time (OS)

  2 years

• Radiation-related (acute / early delayed / late) neurotoxicity

  2 years

• Incidence of symptomatic radionecrosis

  2 years

Study Arms (1)

Radiosurgery

EXPERIMENTAL

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)

Interventions

gamma knife radiosurgery (15 Gy to 50% isodose) RADIATION

Radiosurgery with a gamma knife resembles the application of a precisely focused, high single dose of ionizing irradiation.

Radiosurgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitätsmedizin Mannheim: lead

Study Sites (1)

Department of Radiotherapy University Hospital Mannheim

Mannheim, 68167, Germany

Location

MeSH Terms

Conditions

Glioblastoma

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Frank A Giordano, MD

  University Medical Center Mannheim

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Interim Head, Department of Radiation Oncology

Study Record Dates

• First Submitted: February 9, 2017
• First Posted: February 16, 2017
• Study Start: February 8, 2017
• Primary Completion: March 30, 2020
• Study Completion: May 9, 2023
• Last Updated: May 11, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)