Radiosurgery for Bone Metastases Pain
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Disqualifiers: Prior brain radiation, Curative malignancies, others
No Placebo Group
Approved in 3 Jurisdictions
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.12345
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.46789
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.124510
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
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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
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Trial 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 (Radiation Therapy)
Trial OverviewThe 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
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.
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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
The Sidney Kimmel Comprehsensive Cancer Center at Johns HopkinsBaltimore, MD
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Who Is Running the Clinical Trial?
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor
Accuray IncorporatedIndustry Sponsor
References
Stereotactic hypophysectomy for intractable pain secondary to metastatic prostate carcinoma. [2019]Stereotactic radiofrequency transfrontal hypophysectomy was carried out in 7 patients with osseous metastasis from prostatic carcinoma resulting in intractable pain. 86% experienced significant pain relief with 5 of 7 demonstrating marked decrease in medication requirement and improved level of function. The procedure was done under local anesthesia only with no mortality and minimal morbidity. Total destruction of the pituitary gland and the development of diabetes insipidus were shown not to be necessary conditions for pain relief.
Effectiveness of Leksell gamma knife hypophysectomy on cancer-related intractable pain - a single-center experience. [2023]Hypophysectomy is a method used in analgesia in patients with painful bone metastases. The pain relief after this procedure is not pathophysiologically fully understood. In only a few studies Leksell gamma knife (LGK) was used for radiosurgical hypophysectomy. In our study, we performed the LGK hypophysectomy in patients with intractable cancer-related pain due to bone metastases and evaluated the impact of this method on pain relief.
Automated Stereotactic Gamma Ray Radiosurgery to the Pituitary Gland in Terminally Ill Cancer Patients with Opioid Refractory Pain. [2020]Introduction We report our initial series of terminally ill cancer patients treated with radiosurgery to the pituitary gland to alleviate pain. Methods A fully automated rotating gamma ray unit was used to deliver a high dose of radiation (150Gy) using an 8 mm collimator to the neurohypophysis in 11 patients suffering from opioid-refractory pain deriving from cancer. Results From November 2016 to November 2018, 11 patients were treated, and 10 were eligible for follow-up evaluation. Pain from bone metastases was present in 70%; others suffered from neuropathic and visceral pain. The median survival was 119.7 days (range: 32 to 370). The visual analogue scale (VAS) was nine (7-10) and standardized to 10; eight patients (80%) responded. The average VAS at the time of response was three (range: 1-6), and the average time to response was 2.8 days (range: 2-5). In the first week, 40% of the patients categorized the result as 'excellent', 30% deemed the result 'good', and 20% reported the result as 'poor'. One patient (10%) referred to the result as 'regular'. Those who responded were able to reduce their medications by at least 25%. The one-month average VAS score was five (range: 1-6), 60% reported a 'good' effect, 20% reported 'excellent' results, and 20% had no response. Of the study participants, 60% maintained their level of medicine consumption at lower than baseline. At the end of life, five patients (50%) presented substantial pain, two (20%) never had a therapeutic effect, and three (30%) died without substantial pain. There were no clinical complications that could be attributed directly to the treatment. Conclusion Radiosurgery to the pituitary gland is effective and safe and warrants further investigation to understand its potential role in palliative care in cancer patients.
[Radiosurgical hypophysectomy in painful bone metastases of breast carcinoma]. [2006]Radiosurgical hypophysectomy using Leksell gamma knife was performed to the patient with cancer pain from bone metastases of the breast cancer, relief of the pain was achieved. Patient survived 26 months after hypophysectomy. Review of the literature concerning relief of the pain after hypophysectomy is presented.
Stereotactic radiosurgery for pituitary and cavernous sinus metastases. [2023]Metastases extending to the pituitary gland and cavernous sinus are extremely rare; however, advances in neuroimaging have increased the reported incidence. Stereotactic radiosurgery (SRS) affords the precise delivery of focused radiation to minimize adverse radiation effects. This study assessed the efficacy and safety of SRS in the treatment of pituitary and cavernous sinus metastases.
Stereotactic radiosurgery for metastatic tumors in the pituitary gland and the cavernous sinus. [2022]Metastases to the pituitary gland and cavernous sinus occasionally occur. Metastases of this nature are problematic because they are adjacent to eloquent structures such as cranial nerves, including the optic pathways and nerves for extraocular movement and facial sensation. Stereotactic radiosurgery has been reported to be safe and effective for metastases in various sites of brain parenchyma, providing the tumors are not large. Radiosurgery can be performed to treat a precisely defined target, and the risk of radiation side effects on the surrounding structures is reduced. The results of Gamma Knife surgery (GKS) for the treatment of metastases in the pituitary gland and the cavernous sinus are evaluated.
Fractionated stereotactically guided radiotherapy and radiosurgery in the treatment of functional and nonfunctional adenomas of the pituitary gland. [2022]We evaluated survival rates and side effects after fractionated stereotactically guided radiotherapy (SCRT) and radiosurgery in patients with pituitary adenoma.
Initial clinical results of LINAC-based stereotactic radiosurgery and stereotactic radiotherapy for pituitary adenomas. [2022]To retrospectively evaluate the initial clinical results of stereotactic radiosurgery (SRS) and fractionated stereotactic radiotherapy (SRT) for pituitary adenomas with regard to tumor and hormonal control and adverse effects of the treatment.
Effect of distance from target on hypopituitarism after stereotactic radiosurgery for pituitary adenomas. [2022]Delayed hypopituitarism is the most common complication after stereotactic radiosurgery (SRS) for pituitary adenomas. The aim of this study was to investigate the relationship between the distance from the hypothalamic-pituitary axis to the treatment target and anterior pituitary function preservation after SRS.
[Radiosurgical hypophysectomy in cancer pain treatment. Literature review and clinical case]. [2022]Cancer pain is one of the main problem in modern medicine. According European Society for Medical Oncology data, cancer pain prevalence is 64% among patient with terminal stage of disease and in 46% standard pain therapy was ineffective. Radiosurgical hypophysectomy is one of the important and perspective method in cancer pain treatment. This method could be offered patient with chronic disease. According literature review, endocrinology complications were very rare and occurred 10 months after therapy. Value of analgesic effect was 70-90%. In some trials, procedure was effective not only nociceptive, but also in neuropathic pain. More trials require for determination of indications and mechanism of action. The case of successful relief of resistant pain in patient with pancreatic cancer by means of radiosurgical hypophysectomy is described.