Montag, 19. April 2021
Navigation öffnen
Anzeige:
Lonsurf
 
JOURNAL ONKOLOGIE – STUDIE
ERASER

Evaluation of Repeated Whole Brain Radiotherapy Versus Best Supportive Care for Multiple Brain Metastases.

Rekrutierend

NCT-Nummer:
NCT03288272

Studienbeginn:
April 2016

Letztes Update:
20.09.2017

Wirkstoff:
-

Indikation (Clinical Trials):
Neoplasm Metastasis

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 2

Sponsor:
Stephanie Combs, Stephanie Combs

Collaborator:
-

Studienleiter

Stephanie E Combs, Prof. Dr.
Principal Investigator
Professor and Department Chair

Kontakt

Stephanie E Combs, Prof. Dr.
Kontakt:
Phone: +49-89-4140-
Phone (ext.): 4501
E-Mail: stephanie.combs@tum.de
» Kontaktdaten anzeigen

Studienlocations
(1 von 1)

Technische Universität München (TUM), Klinikum rechts der Isar
81675 Munich
(Bayern)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Stephanie E Combs, Prof. Dr.
Phone: +49-89-4140-
Phone (ext.): 4501
E-Mail: stephanie.combs@tum.de

Carmen Kessel, MA
Phone: +49-89-4140-
Phone (ext.): 4501
E-Mail: carmen.kessel@tum.de
» Ansprechpartner anzeigen

Studien-Informationen

Detailed Description:

According to Nussbaum et al., 24-45% of cancer patients develop cerebral metastases during the course of the disease. Brain metastases are generally associated with a poor prognosis and high morbidity. Published median survival rates after WBRT are between 2 and 7 months. Standard of care in multiple BM is WBRT delivered as 30 Gy in 10 fractions, leading to modest palliation with a median survival of 3 to 5 months. Prognostic factors include the RPA-classification, performance status, response to steroids and evidence of systemic disease.

Unfortunately, intracerebral recurrence happens. For example, in the cohort of Meyners et al.(2010) on WBRT in relatively radioresistant tumors, median time to recurrence was 4.5months and the local control rates at 6 and 12 months post radiationem were 37% and 15%, respectively. Furthermore, the treatment of intracerebral recurrence after previous WBRT is challenging. In case of <!--= 3 recurrent BM, surgery or radiosurgery (RS) are options. One other option, especially in case of -->3 recurrent BM is repeated WBRT. In this setting, one of the first reports on repeated WBRT was published by Cooper et al. in 1990. The authors reported on repeated WBRT (n=52) consisting of 25 Gy in 10 fractions. Response to reirradiation was seen in 42% of the patients. Furthermore, the patients improved by at least one level in their neurologic function status. Survival after second therapy averaged 5 months. In the report by Wong et al. (1996) median dose of retreatment (n=86) was 20 Gy. Resolution of symptoms was achieved in 27% of patients, partial improvement in 43% and no improvement or worsening of symptoms was seen in 29% of patients. The majority of patients had no significant toxicity secondary to re-irradiation. Five patients had radiographic abnormalities of their brain consistent with radiation-related changes. One patient had symptoms of dementia that was thought to be caused by radiotherapy. Sadikov et al. (2007) reported on 72 patients who underwent repeated WBRT for recurrent or progressive BM. The median survival after re-irradiation was 4.1 months. One patient was reported as having memory impairment and pituitary insufficiency after 5 months of progression-free survival.

In the report by Mayer et al. on re-irradiation tolerance of the human brain -in this analysis focused on recurrent glioma-, the authors concluded that radiation-induced brain tissue necrosis is found to occur at normalized tolerance doses of cumulative > 100 Gy.

The current study protocol is aimed at evaluating primarily the toxicity as well as secondarily the local and loco-regional tumor control, overall survival and QoL after repeated WBRT using 2 different dose concepts (20 Gy in 10 Fx vs. 30 Gy in 15 Fx) compared to BSC.

In the present trial, the primary endpoint toxicity as well as the secondary endpoints QoL, loco-regional progression-free survival, overall survival and imaging response in patients previously treated with WBRT requiring repeated WBRT for intracerebral tumor progression will be evaluated.
 

Ein-/Ausschlusskriterien

Inclusion criteria:

- histologically confirmed malignancy

- previous WBRT

- MR-imaging confirmed cerebral metastases (>1)

- age ≥ 18 years of age

- Karnofsky Performance Score ³60

- For women with childbearing potential, (and men) adequate contraception.

- Ability of subject to understand character and individual consequences of the clinical trial

- Written informed consent (must be available before enrolment in the trial)

Exclusion Criteria

- refusal of the patients to take part in the study

- Patients who have not yet recovered from acute high-grade toxicities of prior therapies

- Pregnant or lactating women

- Participation in another clinical study or observation period of competing trials, respectively

Studien-Rationale

Primary outcome:

1. Toxicity (Time Frame - 3 months):
The primary endpoint is toxicity according to CTCAE after whole brain radiotherapy.



Secondary outcome:

1. loco-regional progression-free survival (Time Frame - 6 months):
follow-up and local control of brain metastases as well as loco-regional control

2. Quality of Life (QOL) (Time Frame - 6 months):
QOL

3. Survival (Time Frame - 6 months):
survival after radiotherapy

Studien-Arme

  • Active Comparator: Arm 1 - WBRT 10 x 2 Gy
    Arm 1 - WBRT 10 x 2 Gy Whole brain radiotherapy with a total dose of 20 Gy in single fractions of 2 Gy
  • Active Comparator: Arm 2 - WBRT 15 x 2 Gy
    Arm 2 - WBRT 15 x 2 Gy Whole brain radiotherapy with a total dose of 30 Gy in single fractions of 2 Gy
  • Active Comparator: Arm 3 - Best Supportive Care
    Symptomatic treatment includes steroids, pain medication, nutritional support etc.

Geprüfte Regime

  • Whole Brain Radiotherapy:
    Radiotherapy of the whole brain
  • Best Supportive Care:
    Best Supportive Care including nutrition, pain medication, steroids as needed

Quelle: ClinicalTrials.gov


Das könnte Sie auch interessieren
Krebstherapien können Herz und Gefäße schädigen: Wie schützt man Patienten?
Krebstherapien+k%C3%B6nnen+Herz+und+Gef%C3%A4%C3%9Fe+sch%C3%A4digen%3A+Wie+sch%C3%BCtzt+man+Patienten%3F
©freshidea / Fotolia.de

Die Therapie von Krebserkrankungen hat in den letzten Jahren große Fortschritte gemacht. Verbesserte Operationsmethoden, eine präzisere Strahlenbehandlung und neue Medikamente konnten die Überlebenschancen der Patienten deutlich verbessern. Doch der Fortschritt hat seinen Preis: „Viele Krebstherapien können Herz und Kreislauf schädigen – auch die modernen, zielsicherer an Krebszellen ansetzenden...

Junge Krebspatienten: Ausbildung und Familie, aber auch Angst und Schmerzen
Junge+Krebspatienten%3A+Ausbildung+und+Familie%2C+aber+auch+Angst+und+Schmerzen
© pathdoc / Fotolia.com

„Ich hatte große Träume für mein Leben, jetzt denke ich oft viel, viel kurzfristiger“, sagt die 25-jährige Studentin Mia*, die vor anderthalb Jahren an Krebs erkrankte. Nach der Diagnose musste sie ihr Studium unterbrechen, ihre Familienplanung in Frage stellen und auch mit ihrem Freundeskreis einen neuen Umgang finden. Sie ist eine von rund 15.000 jungen Menschen, die jährlich im Alter von 18 bis 39 Jahren...

Frühlingssonne genießen – Hautkrebs vermeiden: Deutsche Krebshilfe und ADP einfache Tipps gegen Hautkrebs
Fr%C3%BChlingssonne+genie%C3%9Fen+%E2%80%93+Hautkrebs+vermeiden%3A+Deutsche+Krebshilfe+und+ADP+einfache+Tipps+gegen+Hautkrebs
©Thaut Images - stock.adobe.com

Warmes, sonniges Frühlingswetter: „Balsam für die Seele“ nach entbehrungsreichen Winterwochen im Pandemie-Lockdown. Neben wohltuender Wärme und sichtbarem Licht gehören allerdings auch unsichtbare ultraviolette (UV-) Strahlen zum Spektrum der Sonne. Viele Menschen unterschätzen gerade im Frühjahr die Gefahren der schon jetzt intensiven Sonnenbestrahlung. Die Deutsche Krebshilfe und die...