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NCT Number: NCT02104882

INTRAGO-Intraoperative Radiotherapy for Glioblastoma - a Phase I/II Study

Glioblastoma multiforme (GBM) is a disease with an extremely poor prognosis. Despite surgery and radiochemotherapy, the tumors are likely to grow back very quickly.

Intraoperative radiotherapy (IORT) may improve local control rates while sparing healthy tissue (Giordano et al. 2014). IORT takes place before cranioplasty directly after gross (or subtotal) tumor resection. Several past studies on IORT for GBM conducted in Japan and Spain have yielded encouraging results (Sakai et al. 1989; Matsutani et al. 1994; Fujiwara et al. 1995; Ortiz de Urbina et al. 1995).

However, the full potential of the procedure is to date largely unexplored as most previous studies used forward-scattering (electron-based) irradiation techniques, which frequently led to inadequately covered target volumes. With the advent of the spherically irradiation devices such as the Intrabeam® system (Carl Zeiss Meditec AG, Oberkochen, Germany), even complex cavities can be adequately covered with irradiation during IORT. However, there is no data on the maximum tolerated dose of IORT with low-energy X-rays as generated by this system.

The INTRAGO I/II study aims to find out which dose of a single shot of radiation, delivered intraoperatively direct after surgery, is tolerable for patients with GBM. A secondary goal of the study is to find out whether the procedure may improve survival rates.

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Key information

Conditions

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

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Universitätsmedizin Mannheim, University of Heidelberg

Mannheim, 68167, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Histologically confirmed glioblastoma multiforme in frozen sections
  • Age ≥50 years
  • Karnofsky Performance Index ≥ 50%
  • Informed consent
  • Adequate birth control (e.g., oral contraceptives)

Exclusion criteria

  • Astrocytoma ≤ WHO grade III
  • Gliomatosis cerebri
  • Multifocal lesions
  • Infratentorial localization
  • Previous cranial radiation therapy (any location)
  • Uncontrolled intercurrent illnesses including, but not limited to, ongoing or active infection or psychiatric illness/social situations that would limit compliance with study requirements.
  • Contraindications for general anaesthesia
  • Bleeding or clotting disorders
  • Contraindications for MRI or CT scans
  • Pregnant or breastfeeding women

Treatment and study plan

Intraoperative Radiotherapy (Applicator Surface Dose: 20-40 Gy)

Radiation

Primary outcomes

  1. Maximum Tolerated Dose (MTD)

    Time frame: 3 Months

    The maximum tolerated (single) dose of IORT with 50 kV X-rays will be assessed using a classical "3+3" design:

    The first cohort of 3 patients will receive IORT with 20 Gy (prescribed to the applicator surface). If none of these patients experiences a DLT, another three patients will be treated at the next higher dose level (30 Gy). However, should a patient experience a DLT, 3 more patients will be treated at the same dose level. The dose escalation stops if two ore more patients in a cohort of 3-6 patients experience DLT. The MTD is then defined as the dose level just below the toxic dose level.

    Two types of DLT are defined:

    Early DLT (≤ 3 weeks after IORT):

    • wound infections / wound healing difficulties requiring surgical intervention
    • IORT-related cerebral bleeding or ischemia

    Delayed DLT (≤ 3 months after IORT):

    • Symptomatic brain necrosis requiring surgical intervention
    • Early termination of EBRT (before the envisaged dose of 60 Gy) due to radiotoxicity

Secondary outcomes

  1. Progression Free Survival

    Time frame: 3 Years

  2. Overall Survival

    Time frame: 3 Years

Sponsors and collaborators

Lead sponsor

Universitätsmedizin Mannheim

Other

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Apr 7, 2014
Registry last updated
Oct 17, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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