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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a specific type of precise radiation, known as Radiosurgical Hypophysectomy, can reduce severe pain from cancer that has spread to the bones. The treatment delivers a high dose of radiation to a small brain area linked to pain control. It targets individuals whose bone pain persists despite standard treatments like opioids or surgery and significantly impacts their daily life. Participants must have confirmed cancer that has spread to their bones and experience ongoing, hard-to-manage pain. As an unphased trial, this study provides a unique opportunity to explore a novel approach to pain management for those with limited options.

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 prior data suggests that this radiosurgical technique is safe for reducing pain from bone metastases?

Research has shown that radiosurgical hypophysectomy can reduce pain in patients with cancer that has spread to the bones. Studies indicate that this treatment provides significant pain relief for many patients without causing serious side effects. One review found that over 93% of patients experienced pain relief with this method. Another study reported no significant negative effects, highlighting its safety.

Advances in this treatment have made it safer and more effective. Initial pain relief was observed in nearly 96% of patients, and about 74% continued to experience relief over the long term. These findings suggest that radiosurgical hypophysectomy is generally well-tolerated and could be a good option for those seeking to ease cancer-related pain. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike standard treatments for bone metastases pain, which often include medications like opioids or conventional radiation therapy, Radiosurgical Hypophysectomy is unique because it delivers a high dose of radiation (150 Gy) in just a single session. This approach uses precise imaging techniques, such as CT and MRI, to accurately target the affected area, minimizing damage to surrounding tissues. Researchers are excited about this treatment because it has the potential to provide faster and more effective pain relief than traditional methods, which typically require multiple sessions over several weeks.

What evidence suggests that radiosurgical hypophysectomy is effective for reducing pain from bone metastases?

Research has shown that radiosurgical hypophysectomy, a precise radiation treatment targeting the pituitary gland, can significantly relieve pain for cancer patients, including those with bone metastases. One study found that 95.9% of patients initially experienced complete pain relief. Another study reported that 80.2% of patients maintained pain relief over the long term. In this trial, participants will receive a dose of 150 Gy in a single fraction as part of the treatment plan. This noninvasive treatment, which does not involve surgery, is emerging as a promising option for managing severe cancer pain. Overall, the evidence strongly supports its effectiveness in reducing pain for those suffering from bone metastases. ^{1 2 3 4 5}

Who Is on the Research Team?

Kristin Redmond, MD, PhD

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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 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]

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]

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 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]

Citations

1. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0885392425001812

Stereotactic Radiosurgery Hypophysectomy for Palliative ... Stereotactic radiosurgery hypophysectomy offers significant pain relief with minimal side effects for patients suffering from refractory cancer pain, ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7773820/

Stereotactic Radiosurgery Hypophysectomy for Palliative ... Radiosurgery hypophysectomy has reported success in treating hormonal-related cancer pain, nonhormonal cancer pain without bone metastases, and ...

3. frontiersin.org frontiersin.org/journals/neurology/articles/10.3389/fneur.2024.1529944/full

Hypophysectomy, pituitary neuroadenolysis and ... The overall clinical results for initial complete pain relief after pituitary radiosurgery among 64 patients was 95.9% (ranging from 80.0 to ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12228549/

Neuro-Modulation for Intractable Pain From Bone Metastasis ... Radiosurgical hypophysectomy has emerged as a promising noninvasive approach for management of intractable cancer pain, particularly in patients ...

5. karger.com karger.com/sfn/article/doi/10.1159/000547889/931902/Pituitary-targeting-for-intractable-cancer-pain-a

Pituitary Targeting for Intractable Cancer Pain Pain relief was reported in 82.2% and 93.5% for surgery and radiosurgery, respectively. On the long-term, pain relief was maintained in 80.2% ...