RAD ONC FREEDOM Oncology Pain (FREEDOM)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cancer Pain
• Intervention / Treatment: Radiation: Radiosurgery

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 19
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Christy Palodichuk; Phone Number: +1 310-794-2971; Email: cpalodichuk@mednet.ucla.edu
• Study Contact Backup: Name: William Delery; Phone Number: 310-825-5111; Email: WDelery@mednet.ucla.edu

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90095
      • UCLA / Jonsson Comprehensive Cancer Center
      • Contact: Christy Palodichuk; Phone Number: +1 310-794-2971; Email: cpalodichuk@mednet.ucla.edu
      • Contact: William Delery; Phone Number: 310-825-5111; Email: WDelery@mednet.ucla.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment; intracranial functional stereotactic radiosurgery (FnSRS) to the centromedian-parafasciular complex bilaterally, and the hypophysis.	Radiation: Radiosurgery; intracranial functional stereotactic radiosurgery (FnSRS) to the triple target: centromedian-parafasciular complex bilaterally, and the hypophysis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Inventory	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Opioid Usage Quantification	(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	To characterize the side effect profile of FnSRS for treatment of intracranial triple targets	28 days post treatment
Pain anxiety symptom scale (PASS-20)	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:	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	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	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	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	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	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.

Collaborators and Investigators

• Sponsor: Jonsson Comprehensive Cancer Center
• Collaborators: Brainlab AG

Study record dates

Study Major Dates

• Study Start (Estimated): June 5, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2029

Study Registration Dates

• First Submitted: February 25, 2026
• First Submitted That Met QC Criteria: May 18, 2026
• First Posted (Actual): May 26, 2026

Study Record Updates

• Last Update Posted (Actual): June 4, 2026
• Last Update Submitted That Met QC Criteria: June 3, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: reduction
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Cancer Pain; Investigative Techniques; Therapeutics; Surgical Procedures, Operative; Radiotherapy; Stereotaxic Techniques; Neurosurgical Procedures; Radiosurgery
• Other Study ID Numbers: 25-0116

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No