Hypophysectomy by Stereotactic Radiosurgery for Cancer-Related Pain
Trial ID: NCT06287515
Interventional - Phase 1 - Recruiting
To learn if hypophysectomy (treatment of the pituitary gland) using a type of radiation treatment called stereotactic radiosurgery (SRS) can help to relieve cancer-related pain.
Conditions
Interventions
- Stereotactic Radiosurgery
Eligibility
Inclusion criteria
- Age ≥ 18 years old on the day of signing informed consent and willing and able to sign a written informed consent.
- English fluency in order to complete PROs and neurocognitive assessment
- Pathologic or cytologic confirmation of malignancy.
- Poorly controlled intractable nociceptive or mixed pain limiting function or quality of life. Participants must have exhausted or not a candidate for standard of care pain control measures such as opioids, injections/ablations, conventional radiation therapy, or surgical intervention with a curative intent and pain limiting function that affects the participants quality of life in the judgment of the treating physician. Refractory status will require at least consultation and two follow-up visits with pain specialists (pain management or supportive care).
- ECOG performance status of 0-3.
- Life expectancy is greater than 4 weeks and less than 1 year in the treating physician's judgment.
Exclusion criteria
- Participants with prior cranial or head/neck radiation where cumulative organ-at-risk dose constraints cannot be achieved (see section 4.2).
- Inability to have an MRI of the brain for reasons such as a non-compatible bioimplant that could be displaced during MRI, shrapnel embedded (such as from war wounds), metal workers, and machinists (potential for metallic fragments in or near the eyes).
- Expressions of pain due to depression, delirium or addictive behavior
- Participants who are pregnant.
- Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study in the judgment of the Investigators.
Sponsor
M.D. Anderson Cancer Center
Source: ClinicalTrials.gov
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