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De klinische studie NCT05871307 (Radcav) voor Hersenmetastasen, Radiotherapie is rekruterend. Bekijk de kaartweergave van de Klinische Studies Radar en de AI-ontdekkingstools voor alle details. Of stel hier een vraag.
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Neoadjuvant vs. Intraoperative vs. Adjuvant Resection Cavity Radiotherapy of Brain Metastases (Radcav) Fase 2 90

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De klinische studie NCT05871307 (Radcav) onderzoekt behandeling bij Hersenmetastasen, Radiotherapie. Deze Fase 2 interventioneel-studie heeft de status rekruterend. Het doel is om 90 deelnemers te includeren vanaf 1 februari 2024. De studie wordt geleid door University Hospital Heidelberg en de voltooiing is gepland op 1 mei 2028. Laatste update op ClinicalTrials.gov: 8 mei 2024.
Beknopte samenvatting
Patients suffering from malignancies in advanced stages often develop brain metastases, which limit both the life span and the quality of life.

Combining surgery and radiotherapy for resectable brain metastases is standard of care but there is a lot of controversy on which kind of radiotherapy is best suitable. Recently, first volumetric in-silico analyses point to theoretical advantages of neoadjuvant stereotactic ...

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Uitgebreide beschrijving
This trial approach allows for detailed comparison of resected tissue samples, cerebrospinal fluid and blood of all patient groups. So, the investigators will investigate biomaterial of recently irradiated (neoadjuvant and intraoperative arms) and non-irradiated (adjuvant arm) tissue. All this prompts the main issues of the explorative randomized controlled phase 2 RADCAV trial: Is there a difference between neoadjuv...Toon meer
Officiële titel

Neoadjuvant vs. Intraoperative vs. Adjuvant Resection Cavity Radiotherapy of Brain Metastases - A Prospective Randomized Explorative Phase II Trial

Aandoeningen
HersenmetastasenRadiotherapie
Andere studie-ID's
  • Radcav
  • RADOnk-Radcav
NCT-ID
NCT05871307
Startdatum (Werkelijk)
2024-02-01
Laatste update geplaatst
2024-05-08
Verwachte einddatum
2028-05-01
Inschrijving (Geschat)
90
Studietype
Interventioneel
FASE
Fase 2
Status
Rekruterend
Trefwoorden
Brain Metastases
Radiotherapy
Primaire doel
Behandeling
Toewijzing
Gerandomiseerd
Interventiemodel
Parallel
Blindering
Geen (Open-label)
Armen / Interventies
Deelnemersgroep/StudiearmInterventie/Behandeling
ExperimenteelExperimental Arm A (Preoperativ SRS)
Preoperative stereotatic radiosurgery following resection of brain metastases after 1-7 days
Preoperatieve radiotherapie
Resection of brain mestases following
ExperimenteelExperimental Arm B (Intraoperativ SRS)
Intraoperative stereotactic radiotherapy after resection of brain metastases
Intraoperative Radiation
While Resection
Actieve comparatorStandard Treatment Arm C (Posoperativ SRS)
Resection of brain metastases following stereotactic radiotherapy after 2-6 weeks
Postoperatieve radiotherapie
After resection
Primaire uitkomst
UitkomstmaatBeschrijving van de uitkomstmaatTijdsbestek
Assessment of treatment response
number of patients without progresion according to RANO-BM
through study completion, an avarage of 60 month
local tumor control
events of tumor progression or recurrence in the area of 1cm surrounding the resection cavity and surrounding the surgical access
through study completion, an avarage of 60 month
Deelname-assistent
Geschiktheidscriteria

Leeftijd van deelnemers
Volwassene, Oudere volwassene
Minimumleeftijd
18 Years
Geslachten die in aanmerking komen voor de studie
Allen

  • Histologically confirmed solid malignancy

    • Metastatic brain disease (1-10 brain metastases), with at least one brain metastasis in a non-eloquent location (i.e. motor or speech) planned for resection
    • Maximum size of the brain metastasis <5cm
    • Eligibility of patients for both stereotactic radiotherapy and resection
    • Time interval from resection to adjuvant stereotactic radiosurgery of 2-6 weeks
    • Time interval from neoadjuvant stereotactic radiosurgery to resection of 1-7 days
    • Possibility to postpone resection for neoadjuvant stereotactic radiosurgery, if applicable
    • Karnofsky performance scores >= 70 or Eastern Cooperative Oncology Group (ECOG) >= 2 at enrollment
    • Age ≥ 18 years of age
    • 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)

Necessity of immediate surgical resection due to life threatening symptoms

  • brain metastasis directly located (≤10mm) next to the optic system or brain stem
  • Refusal of the patients to take part in the study
  • Small-cell lung cancer (SCLC) or hematologic malignancy as primary malignant illness
  • Leptomeningeal disease suspected RadCav Trial Protocol Version 1.1, 01.07.2022 18
  • Previous radiotherapy of the brain
  • Contraindication for contrast-enhanced MRI
  • Pregnant or lactating women
  • Participation in another competing clinical study or observation period of competing trials, respectively
University Hospital Heidelberg logoUniversity Hospital Heidelberg
Verantwoordelijke instantie
Juergen Debus, Hoofdonderzoeker, Department Director, University Hospital Heidelberg
Centraal Contactpersoon
Contact: Tanja Eichkorn, MD, 06221 56, [email protected]
Contact: Adriane Hommertgen, PhD, 06221 56, [email protected]
1 Studielocaties in 1 landen
Department of Radiotherapy, University of Heidelberg, Heidelberg, 69120, Germany
Juergen Debus, Prof. Dr. Dr., Contact, +49 6221 56, [email protected]
Adriane Hommertgen, Dr. med., Contact, 0622156, [email protected]
Rekruterend