Hypophysectomy by Stereotactic Radiosurgery for Cancer-Related Pain

NCT06287515 | Recruiting Phase 1 DMC FDA Device

• 2 other identifiers: 2023-0940NCI-2024-01986
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hypophysectomy

Outcome Measures

Primary Outcomes (1)

• 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

  Through study completion; an average of 1 year

Study Arms (1)

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.

Device: Stereotactic Radiosurgery

Interventions

Stereotactic Radiosurgery DEVICE

Given by Radiation Therapy

SRS hypophysectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

• MD Anderson Cancer Center

MeSH Terms

Interventions

Radiosurgery

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Chenyang Wang, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chenyang Wang, MD

CONTACT

(832) 710-1570; cwang23@mdanderson.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2024
• First Posted: March 1, 2024
• Study Start: January 6, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: January 14, 2026

Record last verified: 2026-01

Locations

US (1)