Comparison of single radiation before neuro-surgical removal of a brain metastasis with radiation in 5 sessions after removal of the brain metastasis.
Zusammenfassung der Studie
If you decide to participate, you will be randomly assigned to one of the treatment groups to be compared (randomization). The radiotherapy will therefore be performed either once before the operation or in 5 days after the operation, depending on the assignment.
(BASEC)
Untersuchte Intervention
Initial data from the USA show the same good effect of postoperative five-time precision radiation as that of preoperative single radio-surgical radiation. The single radiation also showed a reduction in the recurrence rates of the meninges (so-called meningeal recurrences), namely from 12%-16% to 0%-4%. 7 clinical studies are currently underway or in preparation in the USA. Therefore, we want to conduct the first study of this kind in Europe.
Postoperative radiation will be performed five times with 600 cGy (3000 cGy), three times a week over one and a half weeks. Radiation usually begins two to three weeks after the operation. The dose in the study of preoperative radiation is between 1400 cGy and 2000 cGy in one session. The dose depends on the tumor size. It has been shown that brain metastases with a diameter of up to 5 cm can be irradiated without side effects.
200 patients from hospitals in Switzerland, Germany, and Austria will be treated as part of the study. The study will last a total of 5 years. Half of the patients will be treated with the standard five-time postoperative radiation and the other half with the new preoperative radio-surgery. Only in this way can the two treatment options be compared and the advantages and disadvantages properly assessed.
(BASEC)
Untersuchte Krankheit(en)
All patients for whom surgery for a brain metastasis is recommended can participate in the study. Up to three metastases may also be present, which will be irradiated radio-surgically in 1 to 5 sessions. This may also take place after the operation. All study participants must be at least 18 years old. Patients who cannot undergo magnetic resonance imaging, are in a severely reduced clinical condition, and those who cannot complete the surveys may not participate in the study.
(BASEC)
- Declared willingness to comply with all study procedures and availability for the duration of the study - Age ≥18 years - Ability to take steroids - No contraindication for MRI - MRI diagnosis of a well-defined, contrast-enhanced brain metastasis with a diameter of up to 4.0 cm, suitable for neuro-surgical resection (tumor board decision). Up to 3 additional brain metastases suitable for primary radio-surgery/stereotactic radiation therapy - Complete tumor resection possible according to the assessment of neurosurgery - Estimated survival by the treating physician > 12 months (BASEC)
Ausschlusskriterien
- Radiation-sensitive histology: germ cell tumor, small cell lung cancer, lymphoma, multiple myeloma - >Shift of the midline by more than 10 mm, reduction of the 4th ventricle or other signs of increased intracranial pressure requiring urgent decompressive surgery - More than 4 brain metastases or a diameter of the metastasis to be resected of more than 4.0 cm. 4. More than 1 metastasis requiring resection 5. Leptomeningeal disease in the cerebrospinal fluid or on MRI (unless it is localized and can be irradiated and then resected together with the metastasis) 6. Previous radiation of the brain (SRS/SRT of the lesion to be resected and/or WBRT) 7. Previous resection of a primary or secondary brain tumor 8. Previous diagnosis of a non-meningioma brain tumor 9. Previous radionuclide therapy within 30 days 10. Previous anti-VEGF therapy within 6 weeks 11. Intolerance to radio-surgical stabilization and treatment 12. Inability to provide informed consent (BASEC)
Studienstandort
Aarau, Bern, Chur, Luzern, St Gallen, Winterthur
(BASEC)
Sponsor
Kantonsspital Aarau
(BASEC)
Kontakt für weitere Auskünfte zur Studie
Kontaktperson Schweiz
Dr. med. Susanne Rogers
+41 (0)62 838 5726
susanne.rogers@clutterksa.chRadio-Onkologie-Zentrum Mittelland Kantonsspital Aarau Tellstrasse 25, CH-5001 Aarau
(BASEC)
Allgemeine Auskünfte
Kantonsspital Aarau, Radio-Onkologie-Zentrum Mittelland,
+41 62 838 57 26
susanne.rogers@clutterksa.ch(ICTRP)
Wissenschaftliche Auskünfte
Kantonsspital Aarau, Radio-Onkologie-Zentrum Mittelland,
+41 62 838 57 26
susanne.rogers@clutterksa.ch(ICTRP)
Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Nordwest- und Zentralschweiz EKNZ
(BASEC)
Datum der Bewilligung durch die Ethikkommission
30.11.2021
(BASEC)
ICTRP Studien-ID
NCT05124236 (ICTRP)
Offizieller Titel (Genehmigt von der Ethikkommission)
A multicentre prospective, interventional, randomised trial of preoperative radiosurgery compared with postoperative stereotactic radiotherapy for resectable brain metastases (BASEC)
Wissenschaftlicher Titel
A Multicenter Prospective, Interventional, Randomized Trial of Preoperative Radiosurgery Compared with Postoperative Stereotactic Radiotherapy for Resectable Brain Metastases (ICTRP)
Öffentlicher Titel
Trial of Preoperative Radiosurgery Versus Postoperative Stereotactic Radiotherapy for Resectable Brain Metastases (ICTRP)
Untersuchte Krankheit(en)
Brain Metastases, Adult (ICTRP)
Untersuchte Intervention
Radiation: preoperative radiosurgery;Radiation: postoperative hypofractionated stereotactic radiotherapy (ICTRP)
Studientyp
Interventional (ICTRP)
Studiendesign
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)
Ein-/Ausschlusskriterien
Gender: All
Maximum age: N/A
Minimum age: 18 Years
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 (ICTRP)
nicht verfügbar
Primäre und sekundäre Endpunkte
Leptomeningeal disease (ICTRP)
Local control of the surgical cavity;Distant brain failure;Radionecrosis;Quality of life assessment (ICTRP)
Registrierungsdatum
14.10.2021 (ICTRP)
Einschluss des ersten Teilnehmers
nicht verfügbar
Sekundäre Sponsoren
University of Basel (ICTRP)
Weitere Kontakte
Susanne Rogers, MD PhD;Susanne Rogers, MD PhD, Susanne.rogers@ksa.ch, +41 62 838 57 26, Kantonsspital Aarau, Radio-Onkologie-Zentrum Mittelland, (ICTRP)
Sekundäre IDs
410.000.146 (ICTRP)
Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
nicht verfügbar
Weitere Informationen zur Studie
https://clinicaltrials.gov/ct2/show/NCT05124236 (ICTRP)
Ergebnisse der Studie
Zusammenfassung der Ergebnisse
nicht verfügbar
Link zu den Ergebnissen im Primärregister
nicht verfügbar