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NCT Number: NCT07605546

RAD ONC FREEDOM Oncology 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. 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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Radiosurgery

Radiation

intracranial functional stereotactic radiosurgery (FnSRS) to the triple target: centromedian-parafasciular complex bilaterally, and the hypophysis

Primary outcomes

  1. Pain Inventory

    Time frame: - 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.

Secondary outcomes

  1. Opioid Usage Quantification

    Time frame: 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

  2. functional stereotactic radiosurgery (FnSRS) treatment side effects

    Time frame: 28 days post treatment

    To characterize the side effect profile of FnSRS for treatment of intracranial triple targets

  3. Pain anxiety symptom scale (PASS-20)

    Time frame: 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.

  4. 17-item Hamilton Depression Rating Scale:

    Time frame: 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.

  5. Hamilton Anxiety Rating Scale

    Time frame: 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.

  6. Pittsburgh Sleep Quality Index

    Time frame: 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.

  7. Social disability screening schedule/WHO disability assessment schedule

    Time frame: 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.

  8. Activity of Daily Living Scale

    Time frame: 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.

  9. 36-item Short Form-Health Survey/RAND-36

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Christy Palodichuk

CONTACT

[email protected]

+1 310-794-2971

William Delery

CONTACT

[email protected]

310-825-5111

Sponsors and collaborators

Lead sponsor

Jonsson Comprehensive Cancer Center

Other

Collaborators

  • Brainlab AG

Registry information

Official study title

Functional Radiosurgery for Easing or Eliminating Debilitating Oncologic Morbidity (FREEDOM)

Acronym: FREEDOM

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
May 26, 2026
Registry last updated
Jul 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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