HypophysectomyPhase 1NCT06287515
Hypophysectomy by Stereotactic Radiosurgery for Cancer-Related Pain
A Phase 1 study testing Stereotactic Radiosurgery in people with Hypophysectomy, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypophysectomy
- What is being tested?
- Stereotactic Radiosurgery
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jan 2025to 1 Jul 2027
- Phase
- Phase 1
- 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
- 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.
Who cannot join
- 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.
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
MD Anderson Cancer Center
Houston, Texas, 77030
Chenyang Wang, MD, 832-710-1570, cwang23@mdanderson.org
Chenyang Wang, MD
About this study
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.
Read the detailed description
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
- Conditions
- Hypophysectomy
- Being tested
- Stereotactic Radiosurgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereotactic RadiosurgeryDevice
Given by Radiation Therapy
| Study group | Role | What they receive |
|---|---|---|
| SRS hypophysectomy | Experimental | 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. Receives: Device: Stereotactic Radiosurgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Through study completion; an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2024
- Study start6 Jan 2025
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypophysectomyStudies of the same condition, open and under way.
- More trials run by M.D. Anderson 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 1
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chenyang Wang, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06287515
- Sponsor's protocol ID
- 2023-0940
- Other IDs
- NCI-2024-01986
- Status last verified
- Jul 2026
- First submitted
- 23 Feb 2024
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypophysectomy by Stereotactic Radiosurgery for Cancer-Related Pain
- ClinicalTrials.gov ID
- NCT06287515
- Acronym / sponsor ID
- 2023-0940
- Conditions
- Hypophysectomy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 6 Jan 2025 (actual)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 1 Mar 2024 (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.
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.
Detailed description
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SRS hypophysectomy | Experimental | Device: Stereotactic RadiosurgeryOnce 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
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 |
|---|---|---|
| Stereotactic RadiosurgeryGiven by Radiation Therapy | Device | SRS hypophysectomy |
Primary outcome
Safety and adverse events (AEs)
Time frame: Through study completion; an average of 1 year
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
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 16 Jul 2026.
- MD Anderson Cancer CenterLink provided by the sponsor.
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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.
Chenyang Wang, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Stereotactic Radiosurgery in people with Hypophysectomy, run by M.D. Anderson 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 6 inclusion and 5 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 16 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Chenyang Wang, MD ((832) 710-1570, cwang23@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and adverse events (AEs) (time frame: Through study completion; an average of 1 year). 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 16 Jul 2026.