Clinical trial · Interventional
RAD ONC FREEDOM Oncology Pain
Functional Radiosurgery for Easing or Eliminating Debilitating Oncologic Morbidity (FREEDOM)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer Pain | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radiosurgery | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment
- description
- intracranial functional stereotactic radiosurgery (FnSRS) to the centromedian-parafasciular complex bilaterally, and the hypophysis.
- interventionNames
- Radiation: Radiosurgery
Primary outcomes (1)
- measure
- Pain Inventory
- timeFrame
- - 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
- description
- 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 (9)
- measure
- Opioid Usage Quantification
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available