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Trial record 37 of 961 for:    bone tumors AND NOT metastatic | Recruiting, Not yet recruiting, Available Studies

Radiosurgical Hypophysectomy for Bone Metasteses Pain

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ClinicalTrials.gov Identifier: NCT03377517
Recruitment Status : Recruiting
First Posted : December 19, 2017
Last Update Posted : November 7, 2018
Sponsor:
Collaborator:
Accuray Incorporated
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

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 reducing intractable pain from bone metastases.

Condition or disease Intervention/treatment Phase
Bone Metastases Radiation: radiosurgical hypophysectomy Not Applicable

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 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Patients will be treated to a dose of 150 Gy in a single fraction. All patients will undergo CT simulation with 1 mm slices as well as MRI simulation including at least high resolution 1 mm slice T1 weighted MRI. They will be treated in a supine position using an aquaplast mask system for immobilization.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study of Stereotactic Radiosurgical Hypophysectomy for Intractable Pain From Bone Metastases
Actual Study Start Date : May 8, 2018
Estimated Primary Completion Date : May 1, 2023
Estimated Study Completion Date : March 1, 2025

Arm Intervention/treatment
Experimental: ResearchTreatment Plan
Patients will be treated to a dose of 150 Gy in a single fraction. All patients will undergo CT simulation with 1 mm slices as well as MRI simulation including at least high resolution 1 mm slice T1 weighted MRI. They will be treated in a supine position using an aquaplast mask system for immobilization.
Radiation: radiosurgical hypophysectomy
Patients will be treated to a dose of 150 Gy in a single fraction. All patients will undergo CT simulation with 1 mm slices as well as MRI simulation including at least high resolution 1 mm slice T1 weighted MRI. They will be treated in a supine position using an aquaplast mask system for immobilization.




Primary Outcome Measures :
  1. Change in Intensity of Bone Pain [ Time Frame: 4 weeks ]
    To estimate the rate of clinically meaningful decrease in diffuse osseous pain following radiosurgical hypophysectomy at 4 weeks following completion of radiosurgical hypophysectomy


Secondary Outcome Measures :
  1. Rate of change of disease spread [ Time Frame: Up to 100 weeks following completion of radiosurgical hypophysectomy ]
    To estimate the rate of clinically meaningful decrease in diffuse osseous pain following radiosurgical hypophysectomy

  2. Rate of Change of Quality of Life [ Time Frame: Up to 100 weeks following completion of radiosurgical hypophysectomy ]
    To estimate the rate of clinically meaningful increase in patient reported quality of life following radiosurgical hypophysectomy

  3. Rate of change in opioid use [ Time Frame: Up to 100 weeks following completion of radiosurgical hypophysectomy ]
    To estimate the rate of reduction in opioid utilization following radiosurgical hypophysectomy

  4. Rate of biochemical endocrinopathy [ Time Frame: Up to 100 weeks following completion of radiosurgical hypophysectomy ]
    To estimate the rate of biochemical endocrinopathy following radiosurgical hypophysectomy

  5. Rate of change of optic nueropathy [ Time Frame: Up to 100 weeks following completion of radiosurgical hypophysectomy ]
    To estimate the risk of radiation induced optic neuropathy following radiosurgical hypophysectomy

  6. Rate of change of neurologic toxicity [ Time Frame: Up to 100 weeks following completion of radiosurgical hypophysectomy ]
    To estimate the radiation-associated acute and long term neurologic toxicity of radiosurgical hypophysectomy

  7. Rate of change of insipidus diabetes [ Time Frame: Up to 100 weeks following completion of radiosurgical hypophysectomy ]
    To estimate the rate of diabetes insipidus following radiosurgical hypophysectomy

  8. Rate of change in costs [ Time Frame: Up to 100 weeks following completion of radiosurgical hypophysectomy ]
    To estimate the cost effectiveness of radiosurgical hypophysectomy

  9. Rate of change of cortisol [ Time Frame: Up to 100 weeks following completion of radiosurgical hypophysectomy ]
    To estimate the relationship between pain response and cortisol levels

  10. Rate of change of pain with respect to hormones [ Time Frame: Up to 100 weeks following completion of radiosurgical hypophysectomy ]
    To estimate the rate of pain response in hormonally active and non-hormonally active tumors

  11. Rate of change of pain with respect to morphine [ Time Frame: Up to 100 weeks following completion of radiosurgical hypophysectomy ]
    To estimate the rate of pain response in morphine sensitive and morphine insensitive tumors



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03377517


Contacts
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Contact: Kristin Redmond, MD 410-614-1642 kjanson3@jhmi.edu
Contact: Terrence Caldwell 443-287-1889 caldwte@jhmi.edu

Locations
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United States, Maryland
The Sidney Kimmel Comprehsensive Cancer Center at Johns Hopkins Recruiting
Baltimore, Maryland, United States, 21287
Sub-Investigator: Lawrence Kleinberg, MD         
Sub-Investigator: Michael Lim, MD         
Sub-Investigator: Roberto Salvatori, MD         
Sub-Investigator: Thomas Smith, MD         
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Accuray Incorporated
Investigators
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Principal Investigator: Kristin Redmond, MD Johns Hopkins University

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Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
ClinicalTrials.gov Identifier: NCT03377517     History of Changes
Other Study ID Numbers: J17181
IRB00158648 ( Other Identifier: JHM IRB )
First Posted: December 19, 2017    Key Record Dates
Last Update Posted: November 7, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Neoplasm Metastasis
Bone Neoplasms
Bone Marrow Diseases
Neoplastic Processes
Neoplasms
Pathologic Processes
Neoplasms by Site
Bone Diseases
Musculoskeletal Diseases
Hematologic Diseases