- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT07827001
PilotStudyAssessSafeActiveSurveillancApproachLocalThe Pa w/BrainMetsUndergoinCNSPenetratSystemicThe
A Pilot Study Assessing the Safety of an Active Surveillance Approach to Local Therapy in Patients With Brain Metastases Undergoing CNS-Penetrating Systemic Therapy
This is a Pilot clinical trial determining the safety of an active surveillance approach to local therapy in subjects with brain metastases. These are subjects who are undergoing CNS-penetrating systemic therapy.
Studienübersicht
Status
Studientyp
Einschreibung (Geschätzt)
Kontakte und Standorte
Studienkontakt
- Name: Chao Family Comprehensive Cancer Center University of California, Irvine
- Telefonnummer: 1-877-827-8839
- E-Mail: ucstudy@uci.edu
Studieren Sie die Kontaktsicherung
- Name: University of California Irvine Medical
Studienorte
-
-
California
-
Orange, California, Vereinigte Staaten, 92868
- Rekrutierung
- Chao Family Comprehensive Cancer Center, University of California, Irvine
-
Kontakt:
- Aaron Simon, MD
- Telefonnummer: 1-877-827-8839
- E-Mail: ucstudy@uci.edu
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
Patients with brain metastases undergoing CNS-penetrating systemic therapy
Beschreibung
Inclusion Criteria:
- Patients must have histologically or cytologically confirmed metastatic non-hematologic malignancy.
- Patients must have at least one new or progressive brain metastasis that has not received prior local therapy (surgery or radiation therapy).
- Patients must have no active brain metastasis >3cm in size.
- Leptomeningeal disease is permitted
- Patients with only non-measurable disease as defined by the RANO-BM criteria are permitted so long as the clinical determination of new or progressive disease has been made by the treating team.
- Patients must have no symptoms attributable to active brain metastases.
- At the time of enrollment, patients must be eligible for AND planning to begin a new line of systemic therapy with potential for CNS-efficacy. Determination of potential for CNS-efficacy will be determined based on the clinical judgement of the treating physicians. Patients must have had no prior exposure to the specific systemic therapy in question at the time of enrollment, though exposure to other medications from a similar class are acceptable at the discretion of the treating team.
- Patient must be planning to defer radiation therapy to trial medical therapy regardless of enrollment on trial.
- Must be age ≥ 18 years.
- Patients must be willing to complete MoCA and FACT-BR assessments (refer to section 4.4.1).
- Performance status: KPS performance status ≥50%.
- Life expectancy of ≥3 months.
- Ability to understand and willingness to sign a written informed consent document.
Exclusion Criteria:
- Patients who have only progressive growth of brain lesions that have previously been treated with surgery or radiation therapy.
- Patients with active symptomatic brain metastases.
- Patients requiring corticosteroids, anticonvulsants, or other palliative medications related to brain metastases.
- Patients with conditions that exclude them from undergoing magnetic resonance imaging.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Beobachtungsmodelle: OTHER
- Zeitperspektiven: PROSPECTIVE
Kohorten und Interventionen
Gruppe / Kohorte |
|---|
|
SingleArm
CNS-Penetrating Systemic Therapy |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Feasibility of Enrolling Patients
Zeitfenster: 1 year
|
Feasibility of enrolling patients as measured by percentage of patients enrolled compared to the anticipated study accrual. |
1 year
|
|
Feasibility of completing required surveillance imaging
Zeitfenster: 1 year
|
Feasibility of completing required surveillance imaging as measured by percentage of enrolled patients that complete surveillance imaging. |
1 year
|
|
Feasibility of administering Cognitive Assessments
Zeitfenster: 1 year
|
Feasibility of completing required Cognitive Assessments as measured by percentage of enrolled patients that complete QOL and Cognitive Assessments.. |
1 year
|
|
Feasibility of administering QOL Questionnaires
Zeitfenster: 1 year
|
Feasibility of completing required Quality of Life (QOL) Questionnaires as measured by percentage of enrolled patients that complete QOL and Cognitive Assessments.. |
1 year
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Incidence of pre-defined safety events
Zeitfenster: 1 year
|
Number of subjects who experience incidence of pre-defined safety events associated with progression of intracranial disease while on systemic therapy |
1 year
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Aaron Simon, MD, Chao Family Comprehensive Cancer Center
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- STUDY00001311
- UCI 25-197 (Andere Kennung: UCI CFCCC)
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Beschreibung des IPD-Plans
IPD will only be shared as a condition for publication of study results in ICMJE journals
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .