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Radiation Therapy

Radiosurgery for Bone Metastases Pain

N/A
Recruiting
Led By Kristin Redmond, MD
Research Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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.
Radiographic evidence of bone metastases
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 100 weeks following completion of radiosurgical hypophysectomy
Awards & highlights

Study Summary

This trial is testing if a single, high dose of radiation to a small area of the pituitary gland can help reduce intractable pain from bone metastases.

Who is the study for?
This trial is for adults with confirmed cancer and bone metastases experiencing severe pain not relieved by standard treatments, including opioids or surgery. They should have a life expectancy of at least 4 weeks and be able to consent to the study. Pregnant individuals must avoid participation due to radiation risks.Check my eligibility
What is being tested?
The trial tests whether a single high-dose radiation therapy targeted at the pituitary gland can reduce persistent pain from bone metastases when other treatments haven't worked.See study design
What are the potential side effects?
Potential side effects may include localized discomfort or swelling, fatigue, headaches, hormonal imbalances due to pituitary exposure, nausea, and in rare cases damage to surrounding brain tissue.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have severe pain that hasn't improved with standard treatments, affecting my daily life.
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My cancer has spread to my bones.
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My cancer has spread to bones or organs and gotten worse despite treatment.
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I can understand and am willing to sign the consent form.
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I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 100 weeks following completion of radiosurgical hypophysectomy
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 100 weeks following completion of radiosurgical hypophysectomy for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Intensity of Bone Pain
Secondary outcome measures
Rate of Change of Quality of Life
Rate of biochemical endocrinopathy
Rate of change in costs
+8 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: ResearchTreatment PlanExperimental Treatment1 Intervention
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.

Find a Location

Who is running the clinical trial?

Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor
557 Previous Clinical Trials
32,884 Total Patients Enrolled
Accuray IncorporatedIndustry Sponsor
9 Previous Clinical Trials
865 Total Patients Enrolled
Kristin Redmond, MDPrincipal InvestigatorJohns Hopkins University

Media Library

Radiosurgical Hypophysectomy (Radiation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03377517 — N/A
Bone Metastases Research Study Groups: ResearchTreatment Plan
Bone Metastases Clinical Trial 2023: Radiosurgical Hypophysectomy Highlights & Side Effects. Trial Name: NCT03377517 — N/A
Radiosurgical Hypophysectomy (Radiation Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03377517 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is my profile compatible with the requirements of this medical experiment?

"Eligibility criteria for this medical trial stipulate that patients must be between 18 and 100 years old, with bone metastases. A total of 16 participants are needed to complete the study."

Answered by AI

Is this research endeavor admitting participants beyond the age of 45?

"According to the criteria for inclusion in this study, potential participants must have a minimum age of 18 and not exceed 100."

Answered by AI

Does this research project still accept new participants?

"Affirmative. Evidence on clinicaltrials.gov demonstrate that this research study, which started recruiting individuals in May of 2018, is still enrolling participants. The trial requires 16 people to be recruited from a single medical centre."

Answered by AI

How many participants are actively engaged in this research endeavor?

"Affirmative. According to clinicaltrials.gov, the trial initiated on May 8th 2018 is actively recruiting participants and requires 16 individuals from 1 site for enrolment. The listing was recently updated on October 25th 2022."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Radiosurgical Hypophysectomy for Bone Metasteses Pain
2018. "Radiosurgical Hypophysectomy for Bone Metasteses Pain". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03377517.
~6 spots leftby Dec 2027
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