Intraoperative Radiotherapy After the Resection of Brain Metastases
INTRAMET
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2017
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 28, 2017
CompletedFirst Submitted
Initial submission to the registry
July 18, 2017
CompletedFirst Posted
Study publicly available on registry
July 21, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2023
CompletedJune 3, 2022
June 1, 2022
6.8 years
July 18, 2017
June 2, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Median local progression-free-survival
Rate of recurrence of the treated lesion in the brain
2 years
Secondary Outcomes (7)
Overall-survival
5 years
Time to further therapy
6 month
Patients cognitive performance
5 years
Patients quality of life
5 years
Global progression-free-survival
2 years
- +2 more secondary outcomes
Study Arms (1)
Intraoperative radiotherapy
EXPERIMENTALAfter 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Universitätsmedizin Mannheim
Mannheim, 68167, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stefanie Brehmer, MD
Universitätsmedizin Mannheim
Central Study Contacts
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
- MD
Study Record Dates
First Submitted
July 18, 2017
First Posted
July 21, 2017
Study Start
March 28, 2017
Primary Completion
December 31, 2023
Study Completion
December 31, 2023
Last Updated
June 3, 2022
Record last verified: 2022-06