RAD ONC FREEDOM Oncology Pain (FREEDOM)
6. Juli 2026 aktualisiert von: Jonsson Comprehensive Cancer Center
Functional Radiosurgery for Easing or Eliminating Debilitating Oncologic Morbidity (FREEDOM)
The investigators propose to conduct a study in medically refractory cancer pain patients utilizing radiosurgery to ablate the pituitary hypophysis, as well as neuromodulate the centromedian and parafascicular complexes within the thalami - the so-called triple target.
This involves treating the pituitary hypophysis and thalamus to a dose of 90 Gy.
These patients will have previously failed to achieve adequate pain control with opioid pain regimens and interventional approaches.
The trial will involve a multidisciplinary approach involving radiation oncology, neurosurgery, palliative care, and medical oncology colleagues across UCLA.
Studienübersicht
Detaillierte Beschreibung
Refractory pain is one of the most debilitating challenges in oncology patients, particularly at the end of life. Over 60% of cancer patients experience pain, with 30% of these patients becoming refractory to opioid pain medication. Interventional techniques such as nerve blocks and pain pumps only transiently relieve pain and are often not viable for advanced cancer patients. In patients with diffuse metastatic disease with less than 3-6 months survival, there is a pressing need for a rapid and thorough relief of pain sensation.
Recently, using highly focused radiation delivered to very unique targets in the brain, patients can have marked reduction in perceived pain. There are centers in the brain dubbed as gateways of pain, including the pituitary hypophysis1 and the centromedian and parafascicular complexes2, with some preliminary data also involving the anterior cingulum. Ablation or neuromodulation of these targets with focused high doses of radiation have been shown in small series to provide pain relief in ~3.5 days with a 50% reduction of perceived pain.
The investigators propose to conduct a study in medically refractory cancer pain patients utilizing radiosurgery to ablate the pituitary hypophysis, as well as neuromodulate the centromedian and parafascicular complexes within the thalami - the so-called “triple target.†3 This involves treating the pituitary hypophysis and thalamus to a dose of 90 Gy. These patients will have previously failed to achieve adequate pain control with opioid pain regimens and interventional approaches. This trial will involve a multidisciplinary approach involving radiation oncology, neurosurgery, palliative care, and medical oncology colleagues across UCLA.
Studientyp
Interventionell
Einschreibung (Geschätzt)
19
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienkontakt
- Name: CHRISTY PALODICHUK
- Telefonnummer: +1 310-794-2971
- E-Mail: cpalodichuk@mednet.ucla.edu
Studieren Sie die Kontaktsicherung
- Name: William Delery
- Telefonnummer: 310-825-5111
- E-Mail: WDelery@mednet.ucla.edu
Studienorte
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-
California
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Los Angeles, California, Vereinigte Staaten, 90095
- Rekrutierung
- UCLA / Jonsson Comprehensive Cancer Center
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Kontakt:
- CHRISTY PALODICHUK
- Telefonnummer: +1 310-794-2971
- E-Mail: cpalodichuk@mednet.ucla.edu
-
Kontakt:
- William Delery
- Telefonnummer: 310-825-5111
- E-Mail: WDelery@mednet.ucla.edu
-
-
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Nein
Beschreibung
Inclusion Criteria:
- Male or female ≥ 18 years of age on day of SRS treatment.
- Documentation of insufficiently controlled mixed, complex cancer pain based on Brief Pain Inventory (BPI) >8/10 despite optimization of opioid regimen
- Not eligible for or willing to undergo further pain-relieving interventions
- Written informed consent (and assent when applicable) obtained from patient or patient's legal representative and ability for patient to comply with the study requirements and agree to undergo the study's SRS treatment plan.
Exclusion Criteria:
- Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study.
- Claustrophobia or inability to life flat
- Inability to undergo routine imaging studies
- Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
- Current history of intracranial malignancy or brain metastasis
- Any prior intracranial irradiation
- Previous history of craniotomy, deep brain stimulation (DBS) or laser interstitial themal therapy (LITT).
- Presence of intracranial hardware such as leads for DBS or any other material that may interfere with safe treatment.
- Any comorbidity or condition which would limit full compliance with the protocol
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Unterstützende Pflege
- Zuteilung: N / A
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: Treatment
intracranial functional stereotactic radiosurgery (FnSRS) to the centromedian-parafasciular complex bilaterally, and the hypophysis.
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intracranial functional stereotactic radiosurgery (FnSRS) to the triple target: centromedian-parafasciular complex bilaterally, and the hypophysis
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Pain Inventory
Zeitfenster: - Baseline: Daily measurements on three separate days prior to treatment (Day -7 +/- 3 days, Day -3 +/- 1 day, Day -2 +/- 1 day)- Post-baseline: Days +1, 2, 3, 4, 7, 14, 21, 28
|
For each patient, investigator will measure the Brief Pain Inventory (BPI) (score range: 0-10) at the following days.
Higher score indicates greater pain perception.
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- Baseline: Daily measurements on three separate days prior to treatment (Day -7 +/- 3 days, Day -3 +/- 1 day, Day -2 +/- 1 day)- Post-baseline: Days +1, 2, 3, 4, 7, 14, 21, 28
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Opioid Usage Quantification
Zeitfenster: o Pre-study (screening visit) and Baseline (Day-7, Day-3, & Day-2)o Days +1, 2, 3, 4, 7, 14, 21, 28
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(1) To describe opioid daily consumption pre- and post-treatment
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o Pre-study (screening visit) and Baseline (Day-7, Day-3, & Day-2)o Days +1, 2, 3, 4, 7, 14, 21, 28
|
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functional stereotactic radiosurgery (FnSRS) treatment side effects
Zeitfenster: 28 days post treatment
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To characterize the side effect profile of FnSRS for treatment of intracranial triple targets
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28 days post treatment
|
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Pain anxiety symptom scale (PASS-20)
Zeitfenster: Baseline visit (Day -7) Day +28 after treatment.
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To evaluate the changes in neuropsychiatric metrics, quality of life and executive function after FnSRS for modulation of intracranial triple targets.
Assesses fear, avoidance, and anxiety related to pain.
(0-5, 0=Never, 5=Always); higher scores indicate a worse assessment.
|
Baseline visit (Day -7) Day +28 after treatment.
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17-item Hamilton Depression Rating Scale:
Zeitfenster: Baseline visit (Day -7) Day +28 after treatment.
|
Evaluates the severity of depressive symptoms.
(0-4, 0=Absent, 4=Very Severe); higher scores indicate a worse assessment.
|
Baseline visit (Day -7) Day +28 after treatment.
|
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Hamilton Anxiety Rating Scale
Zeitfenster: Baseline visit (Day -7) Day +28 after treatment.
|
Measures the severity of anxiety symptoms.
(0-4, 0=Not Present, 4=Very Severe); higher scores indicate a worse assessment.
|
Baseline visit (Day -7) Day +28 after treatment.
|
|
Pittsburgh Sleep Quality Index
Zeitfenster: Baseline visit (Day -7) Day +28 after treatment.
|
Assesses sleep quality and disturbances over a one-month period.
(0-3, 0=Not During the past month, 3=Three or more times a week); higher scores indicate a worse assessment.
|
Baseline visit (Day -7) Day +28 after treatment.
|
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Social disability screening schedule/WHO disability assessment schedule
Zeitfenster: Baseline visit (Day -7) Day +28 after treatment.
|
Measures social functioning and disability in various life domains.
(0-4, 0=None, 4=Extreme or Cannot Do); higher scores indicate a worse assessment.
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Baseline visit (Day -7) Day +28 after treatment.
|
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Activity of Daily Living Scale
Zeitfenster: Baseline visit (Day -7) Day +28 after treatment.
|
Evaluates the ability to perform basic self-care and everyday activities.
(0-3 or NA, 0=Appropriate, 3=Cannot do by self alone at all; Not Applicable); higher scores indicate a worse assessment.
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Baseline visit (Day -7) Day +28 after treatment.
|
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36-item Short Form-Health Survey/RAND-36
Zeitfenster: Baseline visit (Day -7) Day +28 after treatment.
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Assesses health-related quality of life across multiple dimensions, including physical, mental, and social well-being.
(0=2, 0=No, not limited at all; 2=Yes, Limited a lot); higher scores indicate a worse assessment.
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Baseline visit (Day -7) Day +28 after treatment.
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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Mitarbeiter
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
9. Juni 2026
Primärer Abschluss (Geschätzt)
1. Juni 2028
Studienabschluss (Geschätzt)
1. Juni 2029
Studienanmeldedaten
Zuerst eingereicht
25. Februar 2026
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
18. Mai 2026
Zuerst gepostet (Tatsächlich)
26. Mai 2026
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
8. Juli 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
6. Juli 2026
Zuletzt verifiziert
1. Juni 2026
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 25-0116
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
NEIN
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Ja
Produkt, das in den USA hergestellt und aus den USA exportiert wird
Nein
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