Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00007337

Trial Description

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Title

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

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

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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Brief Summary in Scientific Language

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Organizational Data

  •   DRKS00007337
  •   2016/03/09
  •   2014/03/26
  •   yes
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Secondary IDs

  •   NCT02104882  (ClinicalTrials.gov)
  •   INTRAGO-I/II  (Universitätsmedizin Mannheim)
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Health Condition or Problem studied

  •   Glioblastoma Multiforme
  •   C71 -  Malignant neoplasm of brain
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Interventions/Observational Groups

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

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   I-II
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Primary Outcome

- 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

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Secondary Outcome

- Progression Free Survival; time frame: 3 Years
- Overall Survival; time frame: 3 Years

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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Recruitment

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  •   2014/03/31
  •   18
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Inclusion Criteria

  •   Both, male and female
  •   50   Years
  •   no maximum age
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Additional 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)

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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

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Addresses

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    • Universitätsmedizin Mannheim
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    • Department of Radiation Oncology, Universitätsmedizin Mannheim, University of Heidelberg
    • Frederik Wenz, MD 
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    • Frank A Giordano, MD 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

  •   Matsutani M, Nakamura O, Nagashima T, Asai A, Fujimaki T, Tanaka H, Nakamura M, Ueki K, Tanaka Y, Matsuda T. Intra-operative radiation therapy for malignant brain tumors: rationale, method, and treatment results of cerebral glioblastomas. Acta Neurochir (Wien). 1994;131(1-2):80-90.; 7709789
  •   Ortiz de Urbina D, Santos M, Garcia-Berrocal I, Bustos JC, Samblas J, Gutierrez-Diaz JA, Delgado JM, Donckaster G, Calvo FA. Intraoperative radiation therapy in malignant glioma: early clinical results. Neurol Res. 1995 Aug;17(4):289-94.; 7477745
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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
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  •   2014/11/05
* This entry means the parameter is not applicable or has not been set.