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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a special type of radiation treatment, called stereotactic radiosurgery, can ease cancer-related pain by targeting the pituitary gland. It is intended for individuals whose cancer-related pain cannot be controlled by standard treatments like medication or surgery. Ideal participants are those experiencing severe, ongoing pain from cancer that significantly impacts daily life and have not found relief with other methods. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative approach.

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 prior data suggests that stereotactic radiosurgery is safe for treating cancer pain?

Research has shown that stereotactic radiosurgery (SRS), a special type of radiation treatment for removing the pituitary gland, is generally safe. One study found that 98.2% of patients experienced less pain without serious side effects such as vision problems. Another study reported that SRS helped relieve pain and was well-tolerated by most patients with cancer pain. Traditional surgery on the pituitary gland can cause issues like hormone imbalances, but SRS has fewer side effects. Overall, SRS for removing the pituitary gland provides significant pain relief with minimal side effects. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for cancer pain, which often include medications like opioids or procedures like nerve blocks, hypophysectomy by stereotactic radiosurgery (SRS) offers a non-invasive approach. This method targets the pituitary gland with precise radiation, potentially reducing pain without the side effects associated with traditional pain meds. Researchers are excited because SRS could provide significant pain relief while minimizing the need for ongoing medication, which is a big win for patients seeking effective, long-term solutions.

What evidence suggests that hypophysectomy by stereotactic radiosurgery might be an effective treatment for cancer pain?

Research shows that stereotactic radiosurgery, a special type of radiation therapy, can greatly reduce cancer-related pain. In one study, 95.9% of patients experienced complete pain relief after this treatment. Another review found that 98.2% of patients improved without serious side effects. This treatment effectively addresses both hormone-related and non-hormone-related cancer pain. Overall, studies indicate that 70-90% of patients experience pain relief. ^{2 3 4 5 6}

Who Is on the Research Team?

Chenyang Wang

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

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

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

Pathologic or cytologic confirmation of malignancy

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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) 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]

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]

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]

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 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]

Citations

1. jpsmjournal.com jpsmjournal.com/article/S0885-3924(25)00181-2/fulltext

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 ... This review highlights the role of hypophysectomy in alleviating advanced cancer pain, both in hormonal and nonhormonal malignancy.

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. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0967586825004163

Review article Unraveling the role of pituitary radiosurgery ... The proportion of patients who demonstrated a response to stereotactic radiosurgery in terms of pain improvement was 98.2 %. No visual complications were ...

5. withpower.com withpower.com/trial/phase-1-hypophysectomy-7-2024-3ed9a

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.

6. 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% ...