A Phase 1 interventional study of Stereotactic Radiosurgery in Hypophysectomy, sponsored by M.D. Anderson Cancer Center. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-16.
Sponsored by M.D. Anderson Cancer Center · Phase 1, Interventional, and Supportive care
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.
Primary Objective:
To determine the feasibility of enrollment and treatment of patients within MD Anderson Cancer Center with SRS hypophysectomy to plan future trials. Feasibility will be defined as completion of SRS hypophysectomy enrollment and treatment of the lead-in cohort (n=20 patients) within one year of trial activation.
Secondary Objectives:
To obtain estimates of the change from baseline over time after SRS hypophysectomy in participants with refractory cancer-related pain in the worst pain subscale of the Brief Pain Inventory (BPI) short form.57
To obtain estimates of the change from baseline over time after SRS hypophysectomy in participants with refractory cancer-related pain in the pain composite scale of the BPI short form.57
To obtain estimates of the change after SRS hypophysectomy in participants with refractory cancer-related pain in the interference scale of the BPI short form.57
To obtain estimates of the change in the daily usage of opioid medications, calculated as oral morphine equivalents (OME), over time after SRS hypophysectomy in participants with refractory cancer-related pain.
To obtain estimates of the change in mood and depressive symptoms using the Hospital Anxiety and Depression Scale (HADS) composite score over time after SRS hypophysectomy in participants with refractory cancer-related pain.60
To obtain estimates of the change in beliefs on self-efficacy using the Pain Self-Efficacy Questionnaire (PSEQ) over time after SRS hypophysectomy in participants with refractory cancer-related pain.61
To obtain estimates of the change after SRS hypophysectomy in participants with refractory cancer-related pain in quality of life as measured by the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 15 Palliative Care (QLC C15 PAL).59 To obtain estimates of neurologic toxicity related to SRS measured by the NCI's CTCAE v5.0.
Correlative Objectives:
To apply novel fMRI and DTI MRI protocols to characterize functional and connectome changes following SRS hypophysectomy.
To study neuroanatomic and histobiochemical changes of the pituitary gland/stalk after SRS hypophysectomy on post-mortem tissue.
To obtain estimates of neurocognitive changes following SRS hypophysectomy in participants with refractory cancer-related pain, including learning and memory (Hopkins Verbal Learning Test-Revised), attention (WAIS-IV Digit Span, Trail Making Test Part A, Stroop test, WAIS-IV Coding), and executive function (Trail Making Test Part B, Controlled Oral Word Association) referred to hereafter as "neurocognitive battery".63-66
M.D. Anderson Cancer Center is the lead sponsor of 2,999 studies on the registry; 581 are open to participants now.
Of its 599 completed or terminated interventional studies of FDA-regulated products, 402 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Once the radiation plan is ready, you will be brought to the radiation treatment room and positioned for treatment. You will be lying on your back on the treatment table during the radiation treatment. You will not see, hear, or feel the radiation during the treatment. The treatment time varies but may range from 1-3 three hours. Once the treatment is completed, the headframe/mask will be removed and you will be brought to a recovery area.
Device: Stereotactic Radiosurgery
Given by Radiation Therapy
Safety and adverse events (AEs)
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Time frame: Through study completion; an average of 1 year
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M.D. Anderson Cancer Center