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RAD ONC FREEDOM Oncology Pain

ConditionCancer Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorJonsson Comprehensive Cancer Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • Radiosurgery

    Radiation

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

Treatment groups

19 Participants
are divided into 1 treatment group
Group A: TreatmentExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

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

Secondary outcomes

1

Opioid Usage Quantification

(1) To describe opioid daily consumption pre- and post-treatment

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
2

functional stereotactic radiosurgery (FnSRS) treatment side effects

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

Time frame
28 days post treatment
3

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.

Time frame
Baseline visit (Day -7) Day +28 after treatment.
4

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.

Time frame
Baseline visit (Day -7) Day +28 after treatment.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Jonsson Comprehensive Cancer Center

Lead sponsor

Brainlab AG

Collaborator

Source ClinicalTrials.gov
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