Cancer PainFREEDOMNCT07605546
RAD ONC FREEDOM Oncology Pain
A study testing Radiosurgery in people with Cancer Pain, run by Jonsson Comprehensive Cancer Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer Pain
- What is being tested?
- Radiosurgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jun 2026to 1 Jun 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, 90095
William Delery, 310-825-5111, WDelery@mednet.ucla.edu
Christy Palodichuk, +1 310-794-2971, cpalodichuk@mednet.ucla.edu
About this study
Official title: 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.
Read the 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.
- Conditions
- Cancer Pain
- Being tested
- Radiosurgery
- Keywords
- reduction
- Medical subject headings
- Cancer Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RadiosurgeryRadiation
intracranial functional stereotactic radiosurgery (FnSRS) to the triple target: centromedian-parafasciular complex bilaterally, and the hypophysis
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | intracranial functional stereotactic radiosurgery (FnSRS) to the centromedian-parafasciular complex bilaterally, and the hypophysis. Receives: Radiation: Radiosurgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: - 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 outcomes (9)
Opioid Usage Quantification
(1) To describe opioid daily consumption pre- and post-treatment
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline visit (Day -7) Day +28 after treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2026
- Study start9 Jun 2026
- Primary completion1 Jun 2028 (estimated)
- Study completion1 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer PainStudies of the same condition, open and under way.
- More trials run by Jonsson Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jonsson Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Brainlab AG
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07605546
- Sponsor's protocol ID
- 25-0116
- Acronym
- FREEDOM
- Status last verified
- Jun 2026
- First submitted
- 25 Feb 2026
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Radiosurgery for Easing or Eliminating Debilitating Oncologic Morbidity (FREEDOM)
- ClinicalTrials.gov ID
- NCT07605546
- Acronym / sponsor ID
- FREEDOM / 25-0116
- Conditions
- Cancer Pain
- Keywords
- reduction
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 19 participants (estimated)
- Lead sponsor
- Jonsson Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- Brainlab AG
- Study start
- 9 Jun 2026 (actual)
- Primary completion
- 1 Jun 2028 (estimated)
- Study completion
- 1 Jun 2029 (estimated)
- First posted
- 26 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Radiation: Radiosurgeryintracranial functional stereotactic radiosurgery (FnSRS) to the centromedian-parafasciular complex bilaterally, and the hypophysis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiosurgeryintracranial functional stereotactic radiosurgery (FnSRS) to the triple target: centromedian-parafasciular complex bilaterally, and the hypophysis | Radiation | Treatment |
Primary outcome
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.
9 secondary outcomes
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
functional stereotactic radiosurgery (FnSRS) treatment side effects
Time frame: 28 days post treatment
Pain anxiety symptom scale (PASS-20)
Time frame: Baseline visit (Day -7) Day +28 after treatment.
17-item Hamilton Depression Rating Scale:
Time frame: Baseline visit (Day -7) Day +28 after treatment.
Hamilton Anxiety Rating Scale
Time frame: Baseline visit (Day -7) Day +28 after treatment.
Pittsburgh Sleep Quality Index
Time frame: Baseline visit (Day -7) Day +28 after treatment.
Social disability screening schedule/WHO disability assessment schedule
Time frame: Baseline visit (Day -7) Day +28 after treatment.
Activity of Daily Living Scale
Time frame: Baseline visit (Day -7) Day +28 after treatment.
36-item Short Form-Health Survey/RAND-36
Time frame: Baseline visit (Day -7) Day +28 after treatment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiosurgery in people with Cancer Pain, run by Jonsson Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact William Delery (310-825-5111, WDelery@mednet.ucla.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2026.