|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
13 June 2022 |
|
Main ID: |
NCT03226483 |
|
Date of registration:
|
18/07/2017 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Intraoperative Radiotherapy After the Resection of Brain Metastases
INTRAMET |
|
Scientific title:
|
Intraoperative Radiotherapy After the Resection of Brain Metastases - a Phase II Feasibility Study |
|
Date of first enrolment:
|
March 28, 2017 |
|
Target sample size:
|
50 |
|
Recruitment status: |
Recruiting |
|
URL:
|
https://clinicaltrials.gov/show/NCT03226483 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
|
|
Phase:
|
N/A
|
|
|
Countries of recruitment
|
|
Germany
| | | | | | | |
|
Contacts
|
|
Name:
|
Stefanie Brehmer, MD |
|
Address:
|
|
|
Telephone:
|
+49 621 383 2750 |
|
Email:
|
stefanie.brehmer@umm.de |
|
Affiliation:
|
|
|
|
Name:
|
Stefanie Brehmer, MD |
|
Address:
|
|
|
Telephone:
|
+49 621 383 2750 |
|
Email:
|
stefanie.brehmer@umm.de |
|
Affiliation:
|
|
|
|
Name:
|
Stefanie Brehmer, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Universitätsmedizin Mannheim |
|
|
Key inclusion & exclusion 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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Brain Metastases
|
|
Intervention(s)
|
|
Radiation: Intraoperative Radiotherapy
|
|
Primary Outcome(s)
|
|
Median local progression-free-survival
[Time Frame: 2 years]
|
|
Secondary Outcome(s)
|
|
Overall-survival
[Time Frame: 5 years]
|
|
Patients quality of life
[Time Frame: 5 years]
|
|
Global progression-free-survival
[Time Frame: 2 years]
|
|
Patients cognitive performance
[Time Frame: 5 years]
|
|
Intraoperative radiotherapy caused dose-limiting toxicities
[Time Frame: 6 month after intervention]
|
|
Regional progression-free-survival
[Time Frame: 2 years]
|
|
Time to further therapy
[Time Frame: 6 month]
|
|
Secondary ID(s)
|
|
2016-638N-MA
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|