Radiosurgical Hypophysectomy for Bone Metasteses Pain

Last updated: June 5, 2024
Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Overall Status: Active - Recruiting

Phase

N/A

Condition

Neoplasm Metastasis

Bone Metastases

Treatment

radiosurgical hypophysectomy

Clinical Study ID

NCT03377517
J17181
IRB00158648
  • Ages 18-100
  • All Genders

Study Summary

This research is being done to see if a delivery of a single high dose of radiation therapy to a small area of the pituitary gland and pituitary stalk in a highly precise manner may be helpful in reducing intractable pain from bone metastases.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Cytologic proof of malignancy

  2. Radiographic evidence of bone metastases

  3. Intractable pain uncontrolled by opioids, medical management, injections/ablation orsurgical intervention that would be difficult to address with conventional radiationtherapy or other standard options and is limiting the patient's function and qualityof life. Intractable pain will be defined as a visual analogue score of at least 4.

  4. Definitive radiographic progression of osseous and/or visceral metastases onstandard staging scans (CT, MRI, bone scan, PET scan or any other standard of careimaging) performed within the last 3 months in spite of standard oncologicinterventions and/or inability to tolerate standard oncologic interventions

  5. Life expectancy at least 4 weeks

  6. Age≥ 18 years

  7. Patients of childbearing potential (male or female) must practice adequatecontraception due to possible harmful effects of radiation therapy on an unbornchild

  8. Patient must have the ability to understand and the willingness to sign a writteninformed consent document

  9. All patients must be informed of the investigational nature of this study and mustbe given written informed consent in accordance with institutional and federalguidelines

Exclusion

Exclusion Criteria:

  1. Prior brain radiation

  2. Patients must not have a serious medical or psychiatric illness that would, in theopinion of the treating physician prevent informed consent or completion of protocoltreatment

  3. Isolated localized pain amenable to focal radiation therapy, or pain well controlledby opioids, medical management, injections/ablation or surgical intervention

  4. Malignancies being managed with curative intent

  5. Life expectancy <4 weeks

  6. The tumor amenable to curative management

Study Design

Total Participants: 16
Treatment Group(s): 1
Primary Treatment: radiosurgical hypophysectomy
Phase:
Study Start date:
May 08, 2018
Estimated Completion Date:
December 31, 2030

Study Description

Although not currently standard of care, small series suggest both safety and efficacy of radiosurgical hypophysectomy in reducing cancer pain from bone metastases. In spite of the demonstrated feasibility in meeting normal tissue constraints and preliminary data suggestive of both safety and efficacy, radiosurgical hypophysectomy is rarely performed in clinical practice, and many radiation oncologists are not even aware of its potential to reduce intractable cancer pain. This is likely because, to date, well-designed prospective studies have not been performed to further explore both the safety and efficacy of the intervention. This single arm pilot study is designed to fill that void. If successful, the investigators plan to utilize the data to support the proposal of a larger scale follow-up clinical trial.

Connect with a study center

  • The Sidney Kimmel Comprehsensive Cancer Center at Johns Hopkins

    Baltimore, Maryland 21287
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.