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Intraoperative Radiotherapy After the Resection of Brain Metastases (INTRAMET)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03226483
Recruitment Status : Recruiting
First Posted : July 21, 2017
Last Update Posted : October 11, 2018
Sponsor:
Information provided by (Responsible Party):
Stefanie Brehmer, Universitätsmedizin Mannheim

Brief Summary:
INTRAMET examines prospectively the effectiveness of an intraoperative radiotherapy immediate after the surgical resection of brain metastases. Patients won't receive further radiation therapy of the intraoperatively treated lesion.

Condition or disease Intervention/treatment Phase
Brain Metastases Radiation: Intraoperative Radiotherapy Not Applicable

Detailed Description:

Brain metastases occur in up to 40% of all patients diagnosed with systemic cancer. Without adjuvant radiotherapy after resection of space occupying lesions local recurrence rates are high. That is why guidelines recommend a cavity boosting with x-rays. External beam radiotherapy can lower the risk of local recurrence but means longer hospitalization, prolongs the time to systemic salvage therapies and bears risks of radionecrosis and leucoencephalopathy with neurological and cognitive decline. A solution for this problem could be onetime intraoperative radiotherapy (IORT) with soft x-rays to sterilize the resection cavity, which may provide both: freedom from local recurrence fast track salvage therapy initiation.

INTRAMET is a single institution, open-label, prospective, phase 2 feasibility study for intraoperative radiotherapy immediately following resection of brain metastases. 50 adult patients with resectable not dural brain metastases should be treated in surgery after tumor resection with IORT with 20-30Gy prescribed to the margin of the resection cavity. The highest dose tolerable to surrounding risk structures (N. opticus, brainstem) should be used.

With this method, the investigators hope to show similar local control rates to postoperative external beam radiotherapy in line with guideline recommendations with less patient hospitalization and faster start of rescue therapies which could lead to a favorable overall outcome and less cognitive side effects.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intraoperative Radiotherapy After the Resection of Brain Metastases - a Phase II Feasibility Study
Actual Study Start Date : March 28, 2017
Estimated Primary Completion Date : April 1, 2019
Estimated Study Completion Date : April 1, 2021

Arm Intervention/treatment
Experimental: Intraoperative radiotherapy

After neurosurgical resection and proven metastasis (frozen section) a local intraoperative radiotherapy with soft energy x-rays is applied to the resection cavity.

To perform this an applicator is inserted into the situs in the tightest fit rule. The highest possible dose between 30-20 Gy is chosen depending on nearby risk structures (Optic nerve, brainstem) is prescribed. After radiotherapy the applicator is removed and the surgery will be finished in standard way.

Radiation: Intraoperative Radiotherapy
Intraoperative Radiotherapy is performed with a mobile radiation device emitting soft energy x-rays in a spherical way. Different size applicators are available to cover the resection cavity after the tightest fit rule.




Primary Outcome Measures :
  1. Median local progression-free-survival [ Time Frame: 2 years ]
    Rate of recurrence of the treated lesion in the brain


Secondary Outcome Measures :
  1. Overall-survival [ Time Frame: 5 years ]
    Survival differentiated between death due to systemic cancer progress and death due to cerebral progress

  2. Time to further therapy [ Time Frame: 6 month ]
    Time to further cancer therapy (e.g. salvage chemotherapy)

  3. Patients cognitive performance [ Time Frame: 5 years ]
    Neuropsychological battery

  4. Patients quality of life [ Time Frame: 5 years ]
    Patient questionary

  5. Global progression-free-survival [ Time Frame: 2 years ]
    Systemic cancer progression-free-survival

  6. Regional progression-free-survival [ Time Frame: 2 years ]
    Progression-free survival concerning other brain metastases

  7. Intraoperative radiotherapy caused dose-limiting toxicities [ Time Frame: 6 month after intervention ]
    Occurrence of wound healing disorders or infection requiring surgical revision, cerebral bleeding or ischemia, radionecrosis requiring surgical intervention



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Karnofsky Performance index ≥ 50%
  • MRI T1 Gadolinium enhancing non-dural resectable lesion
  • Informed consent
  • Adequate birth control
  • Frozen section confirms metastasis
  • Adequate distance to optic nerve and brainstem

Exclusion Criteria:

  • Dural lesions or meningeal carcinomatosis
  • Frozen section reveals glioma, lymphoma,small cell lung cancer or germinoma
  • Psychiatric or social condition interfering compliance
  • Contraindication against anesthesia, surgery, MRI and/or Gadolinium
  • Pregnant or breast-feeding women

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03226483


Contacts
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Contact: Stefanie Brehmer, MD +49 621 383 2750 stefanie.brehmer@umm.de
Contact: Frank A Giordano, MD frank.giordano@umm.de

Locations
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Germany
Universitätsmedizin Mannheim Recruiting
Mannheim, Germany, 68167
Contact: Stefanie Brehmer, MD    +49 621 383 2750    stefanie.brehmer@umm.de   
Contact: Frank A Giordano, MD       frank.giordano@umm.de   
Principal Investigator: Stefanie Brehmer, MD         
Sub-Investigator: Frank Giordano, MD         
Sponsors and Collaborators
Universitätsmedizin Mannheim
Investigators
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Principal Investigator: Stefanie Brehmer, MD Universitätsmedizin Mannheim

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Responsible Party: Stefanie Brehmer, MD, Universitätsmedizin Mannheim
ClinicalTrials.gov Identifier: NCT03226483    
Other Study ID Numbers: 2016-638N-MA
First Posted: July 21, 2017    Key Record Dates
Last Update Posted: October 11, 2018
Last Verified: October 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Stefanie Brehmer, Universitätsmedizin Mannheim:
Brain Metastases
Intraoperative Radiotherapy
Neurosurgery
Additional relevant MeSH terms:
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Neoplasm Metastasis
Neoplasms, Second Primary
Brain Neoplasms
Neoplastic Processes
Neoplasms
Pathologic Processes
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases