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JOURNAL ONKOLOGIE – STUDIE

Fractionated Stereotactic Radiotherapy vs. Single Session Radiosurgery in Patients With Larger Brain Metastases

Rekrutierend

NCT-Nummer:
NCT03697343

Studienbeginn:
Mai 2021

Letztes Update:
13.12.2022

Wirkstoff:
-

Indikation (Clinical Trials):
Neoplasm Metastasis, Brain Neoplasms

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 3

Sponsor:
University of Erlangen-Nürnberg Medical School

Collaborator:
-

Studienleiter

Rainer Fietkau, Prof.
Principal Investigator
Universitätsklinikum Erlangen, Strahlenklinik
Florian Putz, PD Dr.med.
Principal Investigator
Universitätsklinikum Erlangen, Strahlenklinik

Kontakt

Studienlocations
(3 von 13)

Klinik für Strahlentherapie und Radioonkologie Stuttgart
70174 Stuttgart
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Marc Münter, Prof. Dr.
Phone: 0711 278-34201
E-Mail: k.stahl@klinikum-stuttgart.de
» Ansprechpartner anzeigen
Klinik und Poliklinik für RadioOnkologie und Strahlentherapie München (TUM)
81675 München
(Bayern)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Denise Bernhardt, PD Dr.
Phone: +49 89 4140 4501
» Ansprechpartner anzeigen
Klinik für Strahlentherapie und Radioonkologie
53127 Bonn
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Christopher Schmeel, PD Dr.
Phone: +49 228 287-10354
E-Mail: Anmeldung.Strahlentherapie@ukbonn.de
» Ansprechpartner anzeigen
Universitätsklinik und Poliklinik für Strahlentherapie Halle
06120 Halle
(Sachsen-Anhalt)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Christian Dietzel, Dr. med.
Phone: 0345 557 4310
E-Mail: Strahlentherapie@uk-halle.de
» Ansprechpartner anzeigen
Klinik für Strahlentherapie und Radioonkologie Universitätsklinikum Jena
07745 Jena
(Thüringen)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Andrea Wittig, Prof. Dr.
Phone: 03641/9-328401
E-Mail: strahlentherapie@med.uni-jena.de
» Ansprechpartner anzeigen
Klinik für Radioonkologie und Strahlentherapie Charité Berlin
13353 Berlin
(Berlin)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Felix Ehret, Dr. med.
Phone: +49 30 450 527 152
E-Mail: melita.dimitrijevic@charite.de
» Ansprechpartner anzeigen
Erlangen, Universitätsklinikum Strahlenklinik
91054 Erlangen
(Bayern)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Rainer Fietkau, Prof.
Phone: +499131-85-33405
E-Mail: rainer.fietkau@uk-erlangen.de
» Ansprechpartner anzeigen
Alle anzeigen

Studien-Informationen

Detailed Description:

This is a prospective, multicenter randomized trial comparing local control and side effects

after fractionated stereotactic radiotherapy with 12 x 4 Gy and single session radiosurgery

according to RTOG 9005 in patients with larger brain metastases (2-4 cm). Patients will be

randomized to either fractionated stereotactic radiotherapy with 12 x 4 Gy or radiosurgery

with 1 x 18 Gy (2-3 cm) or 1 x 15 Gy (3-4 cm) as defined by the RTOG 9005. Randomization will

be stratified by metastasis volume and histology.

Ein-/Ausschlusskriterien

Inclusion Criteria:

- Age > 18 years, no upper age limit

- Karnofsky Performance Score > 50 points

- Expected Survival > 3 months

- 1-10 cerebral metastases of metastatic solid cancer

- Indication for local radiotherapy

- Patients must be able to understand the protocol and provide informed consent

Exclusion Criteria:

- Whole Brain radiotherapy no longer than 6 weeks before the start of stereotactic

radiotherapy or planned whole brain radiotherapy after stereotactic radiotherapy

- Prior irradiation of the cerebral metastasis that is to be treated in the study

- Relevant overlap of prior radiation fields with the metastasis that is to be treated

in the study

- Metastasis in the brainstem

- Contraindication for cerebral MRI

- Metastasis that is to be treated in the study can't be visualized in contrast-enhanced

T1 MRI sequence

- Pregnant or lactating women

- Abuse of illicit drugs, alcohol or medication

- Patient not able or willing to behave according to protocol

- Participation in another clinical trial

Studien-Rationale

Primary outcome:

1. Time to local progression - TTLP (Time Frame - 12 months):
Local progression will be defined according to the RANO-BM criteria by an increase of at least 20% in the longest diameter of the metastasis relative to nadir or baseline. In addition to the relative increase of 20% the lesion must increase by an absolute value of 5 mm or more. TTLP is defined as the time from randomization until the detection of progression as per the RANO-BM criteria. Patients will be censored if they have no signs of local progression at the time of last tumor monitoring during follow-up or at the onset of one of the following competing risk events not associated with local progression: death, lost to follow up, unauthorized non-protocol treatment of the target lesion. Confirmatory analysis of the primary endpoint variable will be performed using a p-value of p≤0.05 as the global significance level.



Secondary outcome:

1. CNS toxicity according to CTCAE v5.0 (Time Frame - 12 months):
CNS toxicity according to CTCAE v5.0

2. Time to local progression (Volumetric RANO-BM criteria) (Time Frame - 12 months):
Based on the RANO-BM criteria, progression is defined as an increase in volume of 72.8% or more (corresponds to a 20% increase in diameter for a perfect sphere).

3. Quality of Life according to EORTC QLQ-C30 (Time Frame - Change from baseline to 3, 6, 12 and 24 months):
Quality of life measured by European Organization for Research and Treatment of Cancer (EORTC) questionnaire QLQ C30

4. Local-Progression-Free Survival (Time Frame - 12 months):
Local-Progression-Free Survival is defined like TTLP except that death not associated with local progression will not be censored but assessed as a separate event

5. Overall Survival (Time Frame - 24 months):
Overall Survival

6. Quality of Life according to EORTC QLQ-BN20 (Time Frame - Change from baseline to 3, 6, 12 and 24 months):
Quality of life measured by European Organization for Research and Treatment of Cancer (EORTC) questionnaire QLQ BN20

Studien-Arme

  • Other: Radiosurgery with 1 x 18 Gy (2-3 cm) or 1 x 15 Gy (3-4 cm) and
    Radiosurgery with 1 x 18 Gy (2-3 cm) or 1 x 15 Gy (3-4 cm) and no margin as defined by the RTOG 9005
  • Other: Fractionated stereotactic radiotherapy with 12 x 4 Gy and 2 mm
    Fractionated stereotactic radiotherapy with 12 x 4 Gy and 2 mm margin

Geprüfte Regime

  • Radiosurgery:
    Radiosurgery with 1 x 18 Gy (2-3 cm) or 1 x 15 Gy (3-4 cm)
  • Fractionated stereotactic radiotherapy:
    Fractionated stereotactic radiotherapy with 12 x 4 Gy and 2 mm

Quelle: ClinicalTrials.gov


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