Stereotactic Radiosurgery for Cancer Pain

Overseen By Chenyang Wang, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Prior cranial radiation, Pregnancy, Psychiatric disorders, others

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

Compensation: Varies

Number of Visits: 1

Duration: 1 day

40 Participants Needed

Trial Summary

What is the purpose of this trial?

To learn if hypophysectomy (treatment of the pituitary gland) using a type of radiation treatment called stereotactic radiosurgery (SRS) can help to relieve cancer-related pain.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Hypophysectomy by Stereotactic Radiosurgery for cancer pain?

Research shows that stereotactic radiosurgery hypophysectomy can significantly relieve cancer pain, with studies reporting pain relief in 70-90% of cases. It has been effective in reducing pain from various cancers, including breast and prostate cancer, with minimal complications compared to older methods. ^{1 2 3 4 5}

Is stereotactic radiosurgery generally safe for humans?

Stereotactic radiosurgery has been used safely in humans for conditions like cancer pain and pituitary adenomas, with minimal serious side effects reported, though delayed hormone issues can occur. ^{1 4 6 7 8}

How does stereotactic radiosurgery hypophysectomy differ from other treatments for cancer pain?

Stereotactic radiosurgery hypophysectomy is unique because it is a minimally invasive procedure that targets the pituitary gland to relieve cancer pain, potentially reducing the need for opioids and their side effects. Unlike traditional surgical or chemical hypophysectomy, this method uses precise radiation to achieve pain relief with fewer complications. ^{1 2 3 4 5}

Research Team

Chenyang Wang

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

This trial is for individuals experiencing cancer-related pain, who may benefit from a procedure targeting the pituitary gland using radiation (SRS). Specific eligibility criteria are not provided.

Inclusion Criteria

Pathologic or cytologic confirmation of malignancy

I can care for myself but may not be able to do heavy physical work.

My severe pain is not managed by standard treatments and affects my daily life.

Exclusion Criteria

Participants who are pregnant

I have had radiation to my head or neck that now limits further treatment.

Inability to have an MRI of the brain for reasons such as a non-compatible bioimplant that could be displaced during MRI, shrapnel embedded (such as from war wounds), metal workers, and machinists (potential for metallic fragments in or near the eyes)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo SRS hypophysectomy for cancer-related pain relief

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety, effectiveness, and changes in pain, opioid usage, mood, and quality of life

1 year

Treatment Details

Interventions

• Hypophysectomy by Stereotactic Radiosurgery

Trial Overview The trial is testing whether stereotactic radiosurgery, a precise form of radiation therapy aimed at the pituitary gland, can effectively reduce cancer-related pain.

Participant Groups

Group I: SRS hypophysectomy Experimental Treatment 1 Intervention

Once the radiation plan is ready, you will be brought to the radiation treatment room and positioned for treatment. You will be lying on your back on the treatment table during the radiation treatment. You will not see, hear, or feel the radiation during the treatment. The treatment time varies but may range from 1-3 three hours. Once the treatment is completed, the headframe/mask will be removed and you will be brought to a recovery area.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Findings from Research

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]

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]

Gamma Knife surgery (GKS) effectively reduced severe cancer pain in all patients studied, with significant pain relief observed within a median of 2 days, and no serious complications reported, unlike previous treatments that caused severe side effects.

In patients with post-stroke thalamic pain syndrome, 87.5% experienced significant pain reduction, although 71.4% had disease recurrence within 6 months, indicating that while GKS shows promise, further research is needed for long-term management of this type of pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of pituitary radiosurgery for the management of intractable pain and potential future applications. Hayashi, M., Taira, T., Chernov, M., et al.[2017]

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) hypophysectomy is a promising minimally invasive treatment for alleviating cancer-related pain, potentially reducing the need for opioids and their side effects, although the exact mechanism of pain relief is not fully understood.

Despite encouraging results from previous studies, there is a significant need for more rigorous and high-quality clinical trials to validate the efficacy and safety of SRS hypophysectomy in managing pain for advanced cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic Radiosurgery Hypophysectomy for Palliative Treatment of Refractory Cancer Pain: A Historical Review and Update. Larkin, MB., Karas, PJ., McGinnis, JP., et al.[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 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 487 patients who underwent stereotactic radiosurgery (SRS) for pituitary adenomas, maintaining a distance of at least 3.95 mm between the center of the pituitary stalk and the tumor margin isodose was associated with better preservation of anterior pituitary function.

For patients with smaller treatment volumes of less than 2.34 mL, a distance of at least 2.95 mm was optimal for preserving pituitary function, suggesting that surgical techniques could be adjusted to improve outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Neuroanatomic Structural Distances on Pituitary Function After Stereotactic Radiosurgery: A Multicenter Study. Ironside, N., Chen, CJ., Xu, Z., et al.[2023]

References

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

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

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

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

3. Switzerland pubmed.ncbi.nlm.nih.gov

Role of pituitary radiosurgery for the management of intractable pain and potential future applications. [2017]

4. Switzerland pubmed.ncbi.nlm.nih.gov

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

5. Switzerland pubmed.ncbi.nlm.nih.gov

Stereotactic Radiosurgery Hypophysectomy for Palliative Treatment of Refractory Cancer Pain: A Historical Review and Update. [2023]

6. 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]

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

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

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

Effects of Neuroanatomic Structural Distances on Pituitary Function After Stereotactic Radiosurgery: A Multicenter Study. [2023]