JOURNAL ONKOLOGIE – STUDIE
INTRAMET Intraoperative Radiotherapy After the Resection of Brain Metastases
Rekrutierend
NCT-Nummer:
NCT03226483
Studienbeginn:
März 2017
Letztes Update:
18.11.2020
Wirkstoff:
-
Indikation (Clinical Trials):
Neoplasm Metastasis, Neoplasms, Second Primary, Brain Neoplasms
Geschlecht:
Alle
Altersgruppe:
Erwachsene (18+)
Phase:
-
Sponsor:
Universitätsmedizin Mannheim
Collaborator:
-
Studienleiter
Principal Investigator
Universitätsmedizin Mannheim
Kontakt
Kontakt:
Phone: +49 621 383 2750
E-Mail: stefanie.brehmer@umm.de» Kontaktdaten anzeigen
Kontakt:
E-Mail: frank.giordano@umm.de» Kontaktdaten anzeigen
Studienlocations (1 von 1)
Kopf-Hals-Tumorzentrum der Universitätsmedizin Mannheim
68167 Mannheim
DeutschlandRekrutierend» Google-Maps
Ansprechpartner:
Stefanie Brehmer, MD
Phone: +49 621 383 2750
E-Mail: stefanie.brehmer@umm.de
Frank A Giordano, MD
E-Mail: frank.giordano@umm.de» Ansprechpartner anzeigen
68167 Mannheim
DeutschlandRekrutierend» Google-Maps
Ansprechpartner:
Stefanie Brehmer, MD
Phone: +49 621 383 2750
E-Mail: stefanie.brehmer@umm.de
Frank A Giordano, MD
E-Mail: frank.giordano@umm.de» Ansprechpartner anzeigen
Studien-Informationen
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.
Ein-/Ausschlusskriterien
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
Studien-Rationale
Primary outcome:1. Median local progression-free-survival (Time Frame - 2 years):
Rate of recurrence of the treated lesion in the brain
Secondary outcome:
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
Geprüfte Regime
- 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.
Quelle: ClinicalTrials.gov
