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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

Radiographic evidence of bone metastases

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

Must not have

Malignancies being managed with curative intent

Prior brain radiation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 100 weeks following completion of radiosurgical hypophysectomy

Awards & highlights

No Placebo-Only Group

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.

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.

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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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 am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My cancer is being treated with the goal of curing it.

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I have had radiation treatment for my brain.

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My tumor can be treated with the goal of curing it.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 100 weeks following completion of radiosurgical hypophysectomy

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Intensity of Bone Pain

Secondary study objectives

Rate of Change of Quality of Life

Rate of biochemical endocrinopathy

Rate of change in costs

+8 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 6Eligibility criteria met