Radiosurgical Hypophysectomy for Bone Metasteses Pain

Launched by SIDNEY KIMMEL COMPREHENSIVE CANCER CENTER AT JOHNS HOPKINS · Dec 13, 2017

Keywords

ClinConnect Summary

This clinical trial is investigating a new method to help relieve severe pain caused by bone metastases, which are cancerous growths that have spread to the bones. Researchers are exploring whether delivering a single, precise dose of radiation to a small area of the pituitary gland can effectively reduce this pain. This approach may be beneficial for patients whose pain is not managed well with traditional treatments like opioids or other medical interventions.

To be eligible for this trial, participants must be at least 18 years old and have confirmed cancer that has spread to the bones, causing significant pain (rated at least 4 on a scale of 0 to 10). They should also have shown signs of cancer progression despite standard treatments and have a life expectancy of at least 4 weeks. Participants will need to understand the study and provide written consent. If you decide to join, you can expect to receive this targeted radiation therapy and be closely monitored by the medical team throughout the process. It's important to know that this trial is still recruiting participants, and those interested should discuss it with their healthcare provider.

Gender

ALL

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 \<4 weeks
• • 6. The tumor amenable to curative management