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Radiosurgical Hypophysectomy for Bone Metasteses Pain

Primary Purpose

Bone Metastases

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

radiosurgical hypophysectomy

About this trial

This is an interventional treatment trial for Bone Metastases

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Cytologic proof of malignancy
Radiographic evidence of bone metastases
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.
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
Life expectancy at least 4 weeks
Age≥ 18 years
Patients of childbearing potential (male or female) must practice adequate contraception due to possible harmful effects of radiation therapy on an unborn child
Patient must have the ability to understand and the willingness to sign a written informed consent document
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:

Prior brain radiation
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
Isolated localized pain amenable to focal radiation therapy, or pain well controlled by opioids, medical management, injections/ablation or surgical intervention
Malignancies being managed with curative intent
Life expectancy <4 weeks
The tumor amenable to curative management

Sites / Locations

The Sidney Kimmel Comprehsensive Cancer Center at Johns HopkinsRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ResearchTreatment Plan

Arm 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.

Outcomes

Primary Outcome Measures

Change in Intensity of Bone Pain

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

Rate of change of disease spread

To estimate the rate of clinically meaningful decrease in diffuse osseous pain following radiosurgical hypophysectomy

Rate of Change of Quality of Life

To estimate the rate of clinically meaningful increase in patient reported quality of life following radiosurgical hypophysectomy

Rate of change in opioid use

To estimate the rate of reduction in opioid utilization following radiosurgical hypophysectomy

Rate of biochemical endocrinopathy

To estimate the rate of biochemical endocrinopathy following radiosurgical hypophysectomy

Rate of change of optic nueropathy

To estimate the risk of radiation induced optic neuropathy following radiosurgical hypophysectomy

Rate of change of neurologic toxicity

To estimate the radiation-associated acute and long term neurologic toxicity of radiosurgical hypophysectomy

Rate of change of insipidus diabetes

To estimate the rate of diabetes insipidus following radiosurgical hypophysectomy

Rate of change in costs

To estimate the cost effectiveness of radiosurgical hypophysectomy

Rate of change of cortisol

To estimate the relationship between pain response and cortisol levels

Rate of change of pain with respect to hormones

To estimate the rate of pain response in hormonally active and non-hormonally active tumors

Rate of change of pain with respect to morphine

To estimate the rate of pain response in morphine sensitive and morphine insensitive tumors

Full Information

NCT ID

NCT03377517

First Posted

December 8, 2017

Last Updated

May 30, 2023

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Collaborators

Accuray Incorporated

1. Study Identification

Unique Protocol Identification Number

NCT03377517

Brief Title

Radiosurgical Hypophysectomy for Bone Metasteses Pain

Official Title

A Pilot Study of Stereotactic Radiosurgical Hypophysectomy for Intractable Pain From Bone Metastases

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Recruiting

Study Start Date

May 8, 2018 (Actual)

Primary Completion Date

December 2027 (Anticipated)

Study Completion Date

December 2030 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Collaborators

Accuray Incorporated

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Bone Metastases

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

Masking

None (Open Label)

Allocation

N/A

Enrollment

16 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

ResearchTreatment Plan

Arm Type

Experimental

Arm Description

Intervention Type

Radiation

Intervention Name(s)

radiosurgical hypophysectomy

Intervention Description

Primary Outcome Measure Information:

Title

Change in Intensity of Bone Pain

Description

To estimate the rate of clinically meaningful decrease in diffuse osseous pain following radiosurgical hypophysectomy at 4 weeks following completion of radiosurgical hypophysectomy

Time Frame

4 weeks

Secondary Outcome Measure Information:

Title

Rate of change of disease spread

Description

To estimate the rate of clinically meaningful decrease in diffuse osseous pain following radiosurgical hypophysectomy

Time Frame