Intraoperative Radiotherapy After the Resection of Brain Metastases (INTRAMET)
Primary Purpose
Brain Metastases
Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Intraoperative Radiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Brain Metastases focused on measuring Brain Metastases, Intraoperative Radiotherapy, Neurosurgery
Eligibility 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
Sites / Locations
- Universitätsmedizin MannheimRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Intraoperative radiotherapy
Arm Description
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.
Outcomes
Primary Outcome Measures
Median local progression-free-survival
Rate of recurrence of the treated lesion in the brain
Secondary Outcome Measures
Overall-survival
Survival differentiated between death due to systemic cancer progress and death due to cerebral progress
Time to further therapy
Time to further cancer therapy (e.g. salvage chemotherapy)
Patients cognitive performance
Neuropsychological battery
Patients quality of life
Patient questionary
Global progression-free-survival
Systemic cancer progression-free-survival
Regional progression-free-survival
Progression-free survival concerning other brain metastases
Intraoperative radiotherapy caused dose-limiting toxicities
Occurrence of wound healing disorders or infection requiring surgical revision, cerebral bleeding or ischemia, radionecrosis requiring surgical intervention
Full Information
NCT ID
NCT03226483
First Posted
July 18, 2017
Last Updated
June 2, 2022
Sponsor
Universitätsmedizin Mannheim
1. Study Identification
Unique Protocol Identification Number
NCT03226483
Brief Title
Intraoperative Radiotherapy After the Resection of Brain Metastases
Acronym
INTRAMET
Official Title
Intraoperative Radiotherapy After the Resection of Brain Metastases - a Phase II Feasibility Study
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 28, 2017 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universitätsmedizin Mannheim
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Metastases
Keywords
Brain Metastases, Intraoperative Radiotherapy, Neurosurgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intraoperative radiotherapy
Arm Type
Experimental
Arm Description
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.
Intervention Type
Radiation
Intervention Name(s)
Intraoperative Radiotherapy
Intervention Description
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 Measure Information:
Title
Median local progression-free-survival
Description
Rate of recurrence of the treated lesion in the brain
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Overall-survival
Description
Survival differentiated between death due to systemic cancer progress and death due to cerebral progress
Time Frame
5 years
Title
Time to further therapy
Description
Time to further cancer therapy (e.g. salvage chemotherapy)
Time Frame
6 month
Title
Patients cognitive performance
Description
Neuropsychological battery
Time Frame
5 years
Title
Patients quality of life
Description
Patient questionary
Time Frame
5 years
Title
Global progression-free-survival
Description
Systemic cancer progression-free-survival
Time Frame
2 years
Title
Regional progression-free-survival
Description
Progression-free survival concerning other brain metastases
Time Frame
2 years
Title
Intraoperative radiotherapy caused dose-limiting toxicities
Description
Occurrence of wound healing disorders or infection requiring surgical revision, cerebral bleeding or ischemia, radionecrosis requiring surgical intervention
Time Frame
6 month after intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stefanie Brehmer, MD
Phone
+49 621 383 2750
Email
stefanie.brehmer@umm.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stefanie Brehmer, MD
Organizational Affiliation
Universitätsmedizin Mannheim
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universitätsmedizin Mannheim
City
Mannheim
ZIP/Postal Code
68167
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stefanie Brehmer, MD
Phone
+49 621 383 2750
Email
stefanie.brehmer@umm.de
First Name & Middle Initial & Last Name & Degree
A
First Name & Middle Initial & Last Name & Degree
Stefanie Brehmer, MD
12. IPD Sharing Statement
Learn more about this trial
Intraoperative Radiotherapy After the Resection of Brain Metastases
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