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RAD ONC FREEDOM Oncology Pain (FREEDOM)

6 de julio de 2026 actualizado por: 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.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

19

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Copia de seguridad de contactos de estudio

Ubicaciones de estudio

  • Estados Unidos
    • California
      • Los Angeles, California, Estados Unidos, 90095
        • Reclutamiento
        • UCLA / Jonsson Comprehensive Cancer Center
        • Contacto:
        • Contacto:

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

Inclusion Criteria:

  1. Male or female ≥ 18 years of age on day of SRS treatment.
  2. Documentation of insufficiently controlled mixed, complex cancer pain based on Brief Pain Inventory (BPI) >8/10 despite optimization of opioid regimen
  3. Not eligible for or willing to undergo further pain-relieving interventions
  4. 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:

  1. Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study.
  2. Claustrophobia or inability to life flat
  3. Inability to undergo routine imaging studies
  4. 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.
  5. Current history of intracranial malignancy or brain metastasis
  6. Any prior intracranial irradiation
  7. Previous history of craniotomy, deep brain stimulation (DBS) or laser interstitial themal therapy (LITT).
  8. Presence of intracranial hardware such as leads for DBS or any other material that may interfere with safe treatment.
  9. Any comorbidity or condition which would limit full compliance with the protocol

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Cuidados de apoyo
  • Asignación: N / A
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Treatment
intracranial functional stereotactic radiosurgery (FnSRS) to the centromedian-parafasciular complex bilaterally, and the hypophysis.
Radiación: Radiosurgery
intracranial functional stereotactic radiosurgery (FnSRS) to the triple target: centromedian-parafasciular complex bilaterally, and the hypophysis

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Pain Inventory
Periodo de tiempo: - 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.
- 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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Opioid Usage Quantification
Periodo de tiempo: o Pre-study (screening visit) and Baseline (Day-7, Day-3, & Day-2)o Days +1, 2, 3, 4, 7, 14, 21, 28
(1) To describe opioid daily consumption pre- and post-treatment
o Pre-study (screening visit) and Baseline (Day-7, Day-3, & Day-2)o Days +1, 2, 3, 4, 7, 14, 21, 28
functional stereotactic radiosurgery (FnSRS) treatment side effects
Periodo de tiempo: 28 days post treatment
To characterize the side effect profile of FnSRS for treatment of intracranial triple targets
28 days post treatment
Pain anxiety symptom scale (PASS-20)
Periodo de tiempo: Baseline visit (Day -7) Day +28 after treatment.
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.
17-item Hamilton Depression Rating Scale:
Periodo de tiempo: 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.
Hamilton Anxiety Rating Scale
Periodo de tiempo: 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
Periodo de tiempo: 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.
Social disability screening schedule/WHO disability assessment schedule
Periodo de tiempo: 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.
Baseline visit (Day -7) Day +28 after treatment.
Activity of Daily Living Scale
Periodo de tiempo: 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.
Baseline visit (Day -7) Day +28 after treatment.
36-item Short Form-Health Survey/RAND-36
Periodo de tiempo: Baseline visit (Day -7) Day +28 after treatment.
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.
Baseline visit (Day -7) Day +28 after treatment.

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Jonsson Comprehensive Cancer Center

Colaboradores

Brainlab AG

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

9 de junio de 2026

Finalización primaria (Estimado)

1 de junio de 2028

Finalización del estudio (Estimado)

1 de junio de 2029

Fechas de registro del estudio

Enviado por primera vez

25 de febrero de 2026

Primero enviado que cumplió con los criterios de control de calidad

18 de mayo de 2026

Publicado por primera vez (Actual)

26 de mayo de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

8 de julio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

6 de julio de 2026

Última verificación

1 de junio de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 25-0116

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

Sí

producto fabricado y exportado desde los EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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