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Terminated
NCT03377517
Radiosurgical Hypophysectomy for Bone Metasteses Pain
Conditions: Bone Metastases
Sex: All
Ages: 18 Years – 100 Years
Healthy volunteers: No
Phase: NA
Enrollment: 5
Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Location: The Sidney Kimmel Comprehsensive Cancer Center at Johns Hopkins Baltimore Maryland
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 Criteria:
1. Cytologic proof of malignancy
2. Radiographic evidence of bone metastases
3. 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.
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
5. Life expectancy at least 4 weeks
6. Age≥ 18 years
7. Patients of childbearing potential (male or female) must practice adequate contraception due to possible harmful effects of radiation therapy on an unborn child
8. Patient must have the ability to understand and the willingness to sign a written informed consent document
9. 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 Criteria:
1. Prior brain radiation
2. 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
3. Isolated localized pain amenable to focal radiation therapy, or pain well controlled by opioids, medical management, injections/ablation or surgical intervention
4. Malignancies being managed with curative intent
5. Life expectancy \
Source: ClinicalTrials.gov (NCT03377517). StuddyBuddy aggregates publicly available trial information.