Intraoperative Radiotherapy After the Resection of Brain Metastases (INTRAMET)
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|ClinicalTrials.gov Identifier: NCT03226483|
Recruitment Status : Recruiting
First Posted : July 21, 2017
Last Update Posted : October 11, 2018
|Condition or disease||Intervention/treatment||Phase|
|Brain Metastases||Radiation: Intraoperative Radiotherapy||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
- Median local progression-free-survival [ Time Frame: 2 years ]Rate of recurrence of the treated lesion in the brain
- Overall-survival [ Time Frame: 5 years ]Survival differentiated between death due to systemic cancer progress and death due to cerebral progress
- Time to further therapy [ Time Frame: 6 month ]Time to further cancer therapy (e.g. salvage chemotherapy)
- Patients cognitive performance [ Time Frame: 5 years ]Neuropsychological battery
- Patients quality of life [ Time Frame: 5 years ]Patient questionary
- Global progression-free-survival [ Time Frame: 2 years ]Systemic cancer progression-free-survival
- Regional progression-free-survival [ Time Frame: 2 years ]Progression-free survival concerning other brain metastases
- 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
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
|Contact: Stefanie Brehmer, MD||+49 621 383 email@example.com|
|Contact: Frank A Giordano, MDfirstname.lastname@example.org|
|Mannheim, Germany, 68167|
|Contact: Stefanie Brehmer, MD +49 621 383 2750 email@example.com|
|Contact: Frank A Giordano, MD firstname.lastname@example.org|
|Principal Investigator: Stefanie Brehmer, MD|
|Sub-Investigator: Frank Giordano, MD|
|Principal Investigator:||Stefanie Brehmer, MD||Universitätsmedizin Mannheim|