Intraoperative Radiotherapy After the Resection of Brain Metastases

Studien-Informationen Einschlusskriterien Studien-Rationale Geprüfte Regime

Rekrutierend

NCT-Nummer:
NCT03226483

Studienbeginn:
März 2017

Letztes Update:
03.06.2022

Wirkstoff:
-

Indikation (Clinical Trials):
Neoplasm Metastasis, Brain Neoplasms

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Universitätsmedizin Mannheim

Collaborator:
-

Studienleiter

Stefanie Brehmer, MD
Principal Investigator
Universitätsmedizin Mannheim

Kontakt

Stefanie Brehmer, MD
Kontakt:
Phone: +49 621 383 2750
E-Mail: stefanie.brehmer@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

A» 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

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