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JOURNAL ONKOLOGIE – STUDIE
PREOP-2

Trial of Preoperative Radiosurgery Versus Postoperative Stereotactic Radiotherapy for Resectable Brain Metastases

Rekrutierend

NCT-Nummer:
NCT05124236

Studienbeginn:
Juli 2022

Letztes Update:
12.09.2022

Wirkstoff:
-

Indikation (Clinical Trials):
Neoplasm Metastasis, Brain Neoplasms

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Susanne Rogers

Collaborator:
University of Basel, Technische Universität München,

Studienleiter

Susanne Rogers, MD PhD
Principal Investigator
Kantonsspital Aarau, Zentrum für Radio-Onkologie KSA-KSB

Kontakt

Studienlocations
(3 von 6)

Kantonsspital Aarau
5001 Aarau
SwitzerlandRekrutierend» Google-Maps
Ansprechpartner:
Susanne J Rogers, MD PhD
Phone: 0041628385726
E-Mail: susanne.rogers@ksa.ch

Sonja Schwenne
Phone: 0041628386259
E-Mail: sonja.schwenne@ksa.ch» Ansprechpartner anzeigen
Inselspital, Universitätsklinik für Radio-Onkologie
3010 Bern
SwitzerlandRekrutierend» Google-Maps
Ansprechpartner:
Ekin Ermis, Dr. med.
Phone: +41 31 632 26 32
E-Mail: erkin.ermis@insel.ch» Ansprechpartner anzeigen
Alle anzeigen

Studien-Informationen

Detailed Description:

Neurosurgical resection of a brain metastasis in patients with a diagnosis of cancer may be

indicated however the recurrence rate approximates 50% and adjuvant radiotherapy is standard.

Single fraction postoperative stereotactic radiosurgery (SRS) has been widely adopted as a

standard therapy as it achieves equivalent survival and prevents loss of neurocognitive

function as compared with whole brain radiotherapy and improves cavity local control rates as

compared with observation. Hypofractionated stereotactic radiotherapy in 3 to 5 fractions

(hfSRT) is also used in the postoperative setting.

Nodular leptomeningeal disease (nLMD) is a recognised pattern of failure after postoperative

SRS and hfSRT. A 16.9% incidence of nodular LMD was seen after surgery and a similar

incidence of 11%-28%is reported following postoperative SRS in retrospective series. These

data suggest that postoperative SRS/hfSRT have no significant effect on the development of

LMD following surgery.

The incidence of LMD following single fraction preoperative SRS is only 6.1% according to the

largest retrospective series. Preoperative SRS takes advantage of the easier delineation of

an intact BM and sterilizes tumor cells disseminated at surgery. Side effects are minimized

by a smaller planning margin, a dose reduction and resection of the irradiated volume. In

addition, there is no delay to systemic therapy due to wound healing/complications.

Furthermore, a single fraction offers patient convenience.

This trial will randomise and compare intracranial outcomes between single fraction

preoperative SRS and 5 fraction postoperative hFSRT.

Ein-/Ausschlusskriterien

Inclusion Criteria:

1. Provision of signed and dated informed consent form

2. Stated willingness to comply with all study procedures and availability for the

duration of the study

3. Age ≥18

4. Karnofsky performance status ≥60

5. Histological diagnosis of a malignant primary or metastatic tumour

6. Ability to take steroids

7. No contraindication to magnetic resonance imaging (MRI)

8. MRI-diagnosis of a clearly demarcated contrast-enhancing brain metastasis up to 4.0 cm

diameter indicated for neurosurgical resection (tumorboard decision). Up to 3 other

brain metastases suitable for primary radiosurgery/ stereotactic radiotherapy

9. Survival estimated by primary clinician > 12 months

10. Platelet count > 100/ml, INR < 1.3, Hb > 7.5 g/dL

Exclusion Criteria:

1. Radiosensitive histology: germ cell tumour, lymphoma, multiple myeloma

2. >10 mm midline shift, effacement of the 4th ventricle or other sign of raised

intracranial pressure requiring urgent decompressive surgery

3. More than 4 brain metastases or the diameter of the metastasis for resection >4.0 cm.

4. More than 1 metastasis requiring resection

5. Leptomeningeal disease in the CSF or on MRI (unless localized and can be irradiated

then resected with the metastasis)

6. Prior radiation to the brain (SRS/SRT to lesion to be resected and /or WBRT)

7. Prior resection of a primary or secondary brain tumor

8. Prior diagnosis of a non-meningioma brain tumor

9. Prior radionuclide therapy within 30 days

10. Prior anti-VEGF therapy within 6 weeks

11. Unable to tolerate radiosurgery immobilization and treatment

12. Inability to give informed consent

13. Pregnancy or lactation

14. Females of reproductive potential not willing to use effective contraception for at

least 6 months after radiotherapy

15. Males of reproductive potential not effective contraception for 3 months after

radiotherapy

16. Lack of likely compliance with protocol and follow-up

Studien-Rationale

Primary outcome:

1. Leptomeningeal disease (Time Frame - 12 months after intervention):
Incidence (%)



Secondary outcome:

1. Local control of the surgical cavity (Time Frame - 12 months after intervention):
No evidence of tumour recurrence on contrsat-enhanced MRI

2. Distant brain failure (Time Frame - 12 months after intervention):
New brain metastases

3. Radionecrosis (Time Frame - 12 months after intervention):
Adverse radiation effects

4. Quality of life assessment (Time Frame - 3,6,12 months after intervention):
EORTC questionnaire core questionnaire QLQ30, EORTC questionnaire brain module BN 20 (1-4, low scores reflect better QoL)

Studien-Arme

  • Experimental: Preoperative radiosurgery
    The interventional arm is single fraction preoperative radiosurgery to a brain metastasis identified for neurosurgical resection.
  • Active Comparator: Postoperative hypofractionated stereotactic radiotherapy
    The active comparator arm is the standard of care of postoperative hypofractionated stereotactic radiotherapy to the surgical cavity in 5 fractions following resection of the brain metastasis.

Geprüfte Regime

  • preoperative radiosurgery:
    single fraction radiosurgery
  • postoperative hypofractionated stereotactic radiotherapy:
    5 fraction stereotactic radiotherapy /fractionated radiosurgery

Quelle: ClinicalTrials.gov


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