Radiosurgery for Bone Metastases Pain

Overseen By Danielle Wendler, RN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Disqualifiers: Prior brain radiation, Curative malignancies, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 1 day

16 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Do I need to stop my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Radiosurgical Hypophysectomy for bone metastases pain?

Research shows that radiosurgical hypophysectomy, which involves targeting the pituitary gland with focused radiation, has been effective in reducing pain from bone metastases in cancer patients. In several studies, a significant number of patients experienced pain relief and were able to reduce their medication use after the treatment. ^{1 2 3 4 5}

Is radiosurgery safe for treating bone metastases pain?

Radiosurgery has been reported to be generally safe for treating various conditions, including metastases in the brain and pituitary gland, with reduced risk of side effects on surrounding structures. However, delayed hypopituitarism (reduced hormone production by the pituitary gland) is a common complication when treating pituitary adenomas. ^{4 6 7 8 9}

How is the treatment Radiosurgical Hypophysectomy different from other treatments for bone metastases pain?

Radiosurgical Hypophysectomy is unique because it uses focused radiation to target the pituitary gland, providing pain relief for bone metastases without the need for total gland destruction or causing significant side effects. This method is particularly useful for patients with intractable cancer-related pain where standard pain therapies are ineffective. ^{1 2 4 5 10}

Research Team

Kristin Redmond, MD, PhD

Principal Investigator

Johns Hopkins University

Eligibility Criteria

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.

Inclusion Criteria

I have severe pain that hasn't improved with standard treatments, affecting my daily life.

My cancer has spread to my bones.

Cytologic proof of malignancy

Exclusion Criteria

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

You are not expected to live for more than 4 weeks.

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single high dose of 150 Gy radiation therapy to the pituitary gland and pituitary stalk

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including changes in pain, hormone levels, and quality of life

100 weeks

Treatment Details

Interventions

• Radiosurgical Hypophysectomy

Trial Overview 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.

Participant Groups

Group I: ResearchTreatment Plan Experimental Treatment 1 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.

Radiosurgical Hypophysectomy is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Radiosurgical Hypophysectomy for:

• Palliative treatment of intractable pain from bone metastases in patients with advanced cancer

Approved in European Union as Radiosurgical Hypophysectomy for:

• Palliative treatment of severe pain in patients with end-stage cancer

Approved in Canada as Radiosurgical Hypophysectomy for:

• Management of refractory cancer pain

Who Is Running the Clinical Trial?

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Lead Sponsor

Trials

578

Recruited

33,600+

Accuray Incorporated

Industry Sponsor

Trials

11

Recruited

940+

Findings from Research

In a study involving 7 patients with painful osseous metastasis from prostate cancer, 86% experienced significant pain relief after undergoing stereotactic radiofrequency transfrontal hypophysectomy.

The procedure was performed safely under local anesthesia, with no reported mortality and minimal morbidity, indicating it is a viable option for pain management without the need for total pituitary gland destruction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic hypophysectomy for intractable pain secondary to metastatic prostate carcinoma. Moser, RP., Yap, JC., Fraley, EE.[2019]

In a study of 20 patients with painful bone metastases, radiosurgical hypophysectomy using Leksell gamma knife (LGK) resulted in pain relief for 10 evaluated patients, with a reduction of 0-50% in pre-procedural pain lasting for an average of 12.6 months.

The procedure was generally safe, with only a few cases of hormonal imbalances and one instance of temporary nerve palsy, indicating that LGK hypophysectomy can be an effective option for managing intractable cancer-related pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Leksell gamma knife hypophysectomy on cancer-related intractable pain - a single-center experience. May, J., Liscak, R.[2023]

In a study of 11 terminally ill cancer patients treated with radiosurgery to the pituitary gland, 80% experienced significant pain relief, with an average pain score reduction from 9 to 3 within just 2.8 days after treatment.

The treatment was found to be safe, with no direct complications reported, and allowed many patients to reduce their pain medication by at least 25%, suggesting its potential as an effective palliative care option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Automated Stereotactic Gamma Ray Radiosurgery to the Pituitary Gland in Terminally Ill Cancer Patients with Opioid Refractory Pain. Lovo, EE., Campos, FJ., Caceros, VE., et al.[2020]

Radiosurgical hypophysectomy using Leksell gamma knife effectively relieved cancer pain in a patient with breast cancer bone metastases, demonstrating its potential as a treatment option for pain management in similar cases.

The patient experienced a significant survival period of 26 months following the hypophysectomy, suggesting that this intervention may not only alleviate pain but also contribute to improved overall outcomes in cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Radiosurgical hypophysectomy in painful bone metastases of breast carcinoma]. Liscák, R., Vladyka, V.[2006]

Stereotactic radiosurgery (SRS) has been shown to be a safe and effective treatment for metastases in the pituitary gland and cavernous sinus, with local tumor control rates of 82.3% at 1 and 2 years, and overall survival rates of 72.9% at 1 year and 45.3% at 3 years among 23 patients studied.

The procedure is minimally invasive and places little stress on patients, allowing them to continue with further anti-cancer treatments, which is particularly important given the limited survival duration associated with metastatic disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic radiosurgery for pituitary and cavernous sinus metastases. Lin, YY., Wu, HM., Yang, HC., et al.[2023]

In a study of 623 patients treated with Gamma Knife surgery (GKS), only 13 (2.1%) had metastases to the pituitary gland or cavernous sinus, indicating that such cases are relatively rare but can be effectively targeted with GKS.

The treatment resulted in tumor stabilization or reduction in size for six patients, with notable improvements in symptoms like visual function and facial sensation, suggesting that GKS is a safe and effective option for managing these challenging metastases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic radiosurgery for metastatic tumors in the pituitary gland and the cavernous sinus. Mori, Y., Kobayashi, T., Shibamoto, Y.[2022]

Fractionated stereotactically guided radiotherapy (FSRT) and radiosurgery showed a high local tumor control rate of 93% in 68 patients with pituitary adenomas over a mean follow-up of 38.7 months, indicating its efficacy in managing these tumors.

The treatment was found to be safe, with no cases of brain radionecrosis or radiation-induced gliomas reported, although some patients experienced mild side effects like reduced visual acuity and partial hypopituitarism.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fractionated stereotactically guided radiotherapy and radiosurgery in the treatment of functional and nonfunctional adenomas of the pituitary gland. Milker-Zabel, S., Debus, J., Thilmann, C., et al.[2022]

In a study of 48 patients with pituitary adenomas, stereotactic radiosurgery (SRS) achieved a 100% tumor control rate, while fractionated stereotactic radiotherapy (SRT) had an 85.3% control rate, indicating SRS may be more effective for tumor control.

SRT demonstrated a better safety profile, with a 100% rate of freedom from central nervous system adverse effects compared to 72.2% for SRS, suggesting SRT is the preferred treatment method for pituitary tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Initial clinical results of LINAC-based stereotactic radiosurgery and stereotactic radiotherapy for pituitary adenomas. Mitsumori, M., Shrieve, DC., Alexander, E., et al.[2022]

In a study of 224 patients who underwent stereotactic radiosurgery (SRS) for pituitary adenomas, a greater distance between the pituitary gland and the SRS target was linked to better preservation of anterior pituitary function, suggesting that maintaining this distance could help reduce complications.

The study found that the optimal cut-off distance of 15 mm between the pituitary gland and the treatment target had a high specificity (88%) for predicting function preservation, indicating that careful planning of SRS could be crucial for patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of distance from target on hypopituitarism after stereotactic radiosurgery for pituitary adenomas. Ironside, N., Snyder, H., Xu, Z., et al.[2022]

Radiosurgical hypophysectomy shows a significant analgesic effect in cancer pain treatment, with reported effectiveness rates of 70-90%, and can be beneficial for both nociceptive and neuropathic pain.

Endocrinological complications from the procedure are rare, occurring in only a few cases and typically manifesting around 10 months post-therapy, suggesting a favorable safety profile for this treatment in chronic cancer pain patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Radiosurgical hypophysectomy in cancer pain treatment. Literature review and clinical case]. Golanov, AV., Kostjuchenko, VV., Antipina, NA., et al.[2022]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Stereotactic hypophysectomy for intractable pain secondary to metastatic prostate carcinoma. [2019]

2. Sweden pubmed.ncbi.nlm.nih.gov

Effectiveness of Leksell gamma knife hypophysectomy on cancer-related intractable pain - a single-center experience. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Automated Stereotactic Gamma Ray Radiosurgery to the Pituitary Gland in Terminally Ill Cancer Patients with Opioid Refractory Pain. [2020]

4. Czech Republic pubmed.ncbi.nlm.nih.gov

[Radiosurgical hypophysectomy in painful bone metastases of breast carcinoma]. [2006]

5. United States pubmed.ncbi.nlm.nih.gov

Stereotactic radiosurgery for pituitary and cavernous sinus metastases. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Stereotactic radiosurgery for metastatic tumors in the pituitary gland and the cavernous sinus. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Fractionated stereotactically guided radiotherapy and radiosurgery in the treatment of functional and nonfunctional adenomas of the pituitary gland. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Initial clinical results of LINAC-based stereotactic radiosurgery and stereotactic radiotherapy for pituitary adenomas. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Effect of distance from target on hypopituitarism after stereotactic radiosurgery for pituitary adenomas. [2022]

10. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Radiosurgical hypophysectomy in cancer pain treatment. Literature review and clinical case]. [2022]