NCT07605546

Brief 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. 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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for not_applicable

Timeline
36mo left

Started Jun 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress1%
Jun 2026Jun 2029

First Submitted

Initial submission to the registry

February 25, 2026

Completed
3 months until next milestone

First Posted

Study publicly available on registry

May 26, 2026

Completed
10 days until next milestone

Study Start

First participant enrolled

June 5, 2026

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2028

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2029

Last Updated

June 4, 2026

Status Verified

June 1, 2026

Enrollment Period

2 years

First QC Date

February 25, 2026

Last Update Submit

June 3, 2026

Conditions

Cancer Pain

Keywords

reduction

Outcome Measures

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.

    - 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

    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

    28 days post treatment

  • Pain anxiety symptom scale (PASS-20)

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

  • 17-item Hamilton Depression Rating Scale:

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

  • Hamilton Anxiety Rating Scale

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

  • +4 more secondary outcomes

Study Arms (1)

Treatment

EXPERIMENTAL

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

Radiation: Radiosurgery

Interventions

RadiosurgeryRADIATION

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

Treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCLA / Jonsson Comprehensive Cancer Center

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

Cancer Pain

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

RadiotherapyTherapeuticsStereotaxic TechniquesNeurosurgical ProceduresSurgical Procedures, OperativeInvestigative Techniques

Central Study Contacts

William Delery

CONTACT

310-825-5111WDelery@mednet.ucla.edu

Christy Palodichuk

CONTACT

+1 310-794-2971cpalodichuk@mednet.ucla.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 25, 2026

First Posted

May 26, 2026

Study Start

June 5, 2026

Primary Completion (Estimated)

June 1, 2028

Study Completion (Estimated)

June 1, 2029

Last Updated

June 4, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)