Status:
RECRUITING
Radiosurgical Hypophysectomy for Bone Metasteses Pain
Lead Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborating Sponsors:
Accuray Incorporated
Conditions:
Bone Metastases
Eligibility:
All Genders
18-100 years
Phase:
NA
Brief 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 redu...
Detailed 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 feasib...
Eligibility Criteria
Inclusion
- Cytologic proof of malignancy
- Radiographic evidence of bone metastases
- Intractable pain uncontrolled by opioids, medical management, injections/ablation or surgical intervention that would be difficult to address with conventional radiation therapy or other standard options and is limiting the patient's function and quality of life. Intractable pain will be defined as a visual analogue score of at least 4.
- Definitive radiographic progression of osseous and/or visceral metastases on standard staging scans (CT, MRI, bone scan, PET scan or any other standard of care imaging) performed within the last 3 months in spite of standard oncologic interventions and/or inability to tolerate standard oncologic interventions
- Life expectancy at least 4 weeks
- Age≥ 18 years
- Patients of childbearing potential (male or female) must practice adequate contraception due to possible harmful effects of radiation therapy on an unborn child
- Patient must have the ability to understand and the willingness to sign a written informed consent document
- All patients must be informed of the investigational nature of this study and must be given written informed consent in accordance with institutional and federal guidelines
Exclusion
- Prior brain radiation
- Patients must not have a serious medical or psychiatric illness that would, in the opinion of the treating physician prevent informed consent or completion of protocol treatment
- Isolated localized pain amenable to focal radiation therapy, or pain well controlled by opioids, medical management, injections/ablation or surgical intervention
- Malignancies being managed with curative intent
- Life expectancy \<4 weeks
- The tumor amenable to curative management
Key Trial Info
Start Date :
May 8 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2030
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT03377517
Start Date
May 8 2018
End Date
December 1 2030
Last Update
July 3 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
The Sidney Kimmel Comprehsensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21287