Stereotactic Radiosurgery for Brain Metastases from Lung Cancer

Recruiting at 7 trial locations

Overseen By Brandon Imber, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Memorial Sloan Kettering Cancer Center

Disqualifiers: Leptomeningeal disease, Pregnant, Prior radiotherapy, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 6 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

62 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of the study is to see if stereotactic radiosurgery/SRS is an effective treatment for people with a new diagnosis of brain metastases from small cell lung cancer/SCLC.

Will I have to stop taking my current medications?

The trial information does not specify whether 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 Stereotactic Radiosurgery for brain metastases from lung cancer?

Research shows that Stereotactic Radiosurgery (SRS) is effective in prolonging survival for patients with a single brain metastasis and maintaining functional independence for those with up to three brain metastases. It is a precise treatment option that has become standard for patients with few metastatic brain lesions, offering an alternative to whole brain radiation therapy. ^{1 2 3 4 5}

Is stereotactic radiosurgery (SRS) safe for humans?

Stereotactic radiosurgery (SRS), including treatments like CyberKnife and Gamma Knife, has been shown to be generally safe for treating brain metastases and lung tumors, with studies reporting acceptable levels of side effects and good local tumor control. ^{6 7 8 9 10}

How does the treatment Stereotactic Radiosurgery (SRS) for brain metastases from lung cancer differ from other treatments?

Stereotactic Radiosurgery (SRS) is unique because it delivers a highly focused, single session of radiation directly to the brain metastases, minimizing exposure to surrounding healthy tissue. This approach reduces the need for invasive surgery and avoids the broader side effects associated with whole brain radiation therapy. ^{1 2 11 12 13}

Research Team

Luke Pike, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

This trial is for adults with small cell lung cancer that has spread to the brain. They must be able to consent, have a good performance status (able to carry out daily activities), and women must not be pregnant. People can't join if they've had previous brain radiotherapy, are pregnant or breastfeeding, can't undergo MRI scans, or have uncontrolled systemic disease.

Inclusion Criteria

The patient or legally authorized representative is able to provide informed consent

I am not able to become pregnant or I have a negative pregnancy test.

I have up to 10 brain tumors identified by MRI.

Exclusion Criteria

You cannot have an MRI with a special dye to show clearer pictures of your brain or spine.

Pregnant or lactating women

I have a severe illness with no treatment options, confirmed by scans within the last 3 months.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive stereotactic radiosurgery (SRS) for brain metastases from small cell lung cancer

6 weeks

Follow-up

Participants are monitored for overall survival and effectiveness of the treatment

6 months

Treatment Details

Interventions

• Stereotactic Radiosurgery

Trial Overview The study is testing Stereotactic Radiosurgery (SRS) as a treatment for patients with newly diagnosed brain metastases from small cell lung cancer. It will involve precise delivery of radiation to the brain tumors without affecting surrounding healthy tissue.

Participant Groups

Group I: Participants with small cell lung cancer with brain metastases Experimental Treatment 2 Interventions

Participants may be newly diagnosed small cell lung cancer with brain metastases at initial staging, or can alternatively be patients who develop brain metastases on therapy or during surveillance of systemic disease.

Stereotactic Radiosurgery is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

Approved in European Union as Stereotactic Radiosurgery for:

• Brain tumors
• Metastatic brain tumors
• Arteriovenous malformations (AVMs)
• Trigeminal neuralgia
• Acoustic neuromas

Approved in United States as Stereotactic Radiosurgery for:

• Brain tumors
• Metastatic brain tumors
• Arteriovenous malformations (AVMs)
• Trigeminal neuralgia
• Acoustic neuromas
• Liver tumors
• Lung tumors
• Spinal cord tumors

Approved in Canada as Stereotactic Radiosurgery for:

• Brain tumors
• Metastatic brain tumors
• Arteriovenous malformations (AVMs)
• Trigeminal neuralgia
• Acoustic neuromas

Approved in Japan as Stereotactic Radiosurgery for:

• Brain tumors
• Metastatic brain tumors
• Arteriovenous malformations (AVMs)
• Trigeminal neuralgia
• Acoustic neuromas

Approved in China as Stereotactic Radiosurgery for:

• Brain tumors
• Metastatic brain tumors
• Arteriovenous malformations (AVMs)
• Trigeminal neuralgia
• Acoustic neuromas

Approved in Switzerland as Stereotactic Radiosurgery for:

• Brain tumors
• Metastatic brain tumors
• Arteriovenous malformations (AVMs)
• Trigeminal neuralgia
• Acoustic neuromas

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Findings from Research

Stereotactic radiosurgery (SRS) using CyberKnife for large brain metastasis cavities (≥2 cm) showed a local failure rate of 24%, indicating it can effectively control local disease after surgery.

Patients with synchronous metastases had a higher risk of distant brain failure, suggesting that while SRS can delay the need for whole brain radiation therapy (WBRT), careful monitoring is needed for those with multiple metastases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intracranial control after Cyberknife radiosurgery to the resection bed for large brain metastases. Vogel, J., Ojerholm, E., Hollander, A., et al.[2018]

Stereotactic radiosurgery (SRS) can effectively control brain metastases from small cell lung cancer (SCLC) for lesions smaller than 2 cm, with local control rates of 81% at 6 months and 69% at 12 months.

However, larger lesions (>2 cm) are more likely to fail treatment, especially if treated with doses less than 16 Gy, highlighting the importance of aggressive treatment for patients with limited CNS involvement and controlled systemic disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Local recurrence and survival following stereotactic radiosurgery for brain metastases from small cell lung cancer. Rava, P., Sioshansi, S., DiPetrillo, T., et al.[2016]

In a study of 156 non-small cell lung cancer patients with 1-4 brain metastases, stereotactic radiosurgery (LINAC-SRS) did not show significantly better overall survival compared to whole-brain radiotherapy (WBRT) or WBRT plus radiotherapy boost (WBRT+RTB).

The median overall survival was not reached for the LINAC-SRS group, while it was 33.3 months for WBRT and 27.9 months for WBRT+RTB, indicating that LINAC-SRS may not provide a clear advantage in treatment outcomes for these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-world analysis of different intracranial radiation therapies in non-small cell lung cancer patients with 1-4 brain metastases. Chen, Z., Zhou, L., Zhao, M., et al.[2022]

Stereotactic radiosurgery (SRS) for patients with 5 or more melanoma brain metastases showed a high local control rate of 91.3% at 6 months and 82.2% at 12 months, indicating its effectiveness as a treatment option.

The study found that a larger planning target volume (PTV) was a significant predictor of local failure, highlighting the importance of careful treatment planning in achieving better outcomes for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Potential role for LINAC-based stereotactic radiosurgery for the treatment of 5 or more radioresistant melanoma brain metastases. Frakes, JM., Figura, NB., Ahmed, KA., et al.[2016]

Stereotactic radiosurgery (SRS) is an effective treatment for patients with brain metastases, particularly prolonging survival for those with a single metastasis and maintaining functional independence for patients with up to three metastases.

As SRS technology becomes more widely used, careful patient selection and treatment planning are essential to maximize its benefits and integrate it safely with other therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New developments in intracranial stereotactic radiotherapy for metastases. Pinkham, MB., Whitfield, GA., Brada, M.[2022]

Stereotactic ablative radiotherapy (SABR) using Cyberknife demonstrated high effectiveness in treating stage I non-small-cell lung cancer, with 2-year local control, progression-free, and overall survival rates of 91.9%, 61.7%, and 84.8%, respectively, based on a study of 153 patients.

The treatment was generally safe, with only 8.1% of patients experiencing severe toxicities, including one case of grade 5 radiation pneumonitis, indicating that while SABR is effective, careful monitoring for side effects is necessary.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic Ablative Radiotherapy Using CyberKnife for Stage I Non-small-cell Lung Cancer: A Retrospective Analysis. Hayashi, K., Suzuki, O., Shiomi, H., et al.[2022]

In a study of 106 patients with early-stage non-small cell lung cancer treated with CyberKnife® SBRT, the treatment demonstrated an 88% local control rate at 2 years, indicating its efficacy in managing this type of cancer.

The treatment was associated with low toxicity, with only 20% of patients experiencing mild fatigue and 17% mild dyspnea, and only 4% experiencing significant late effects, suggesting it is a safe option for medically inoperable patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk-adapted robotic stereotactic body radiation therapy for inoperable early-stage non-small-cell lung cancer. Temming, S., Kocher, M., Stoelben, E., et al.[2022]

In a study of 4,327 patients with brain metastases from non-small cell lung cancer, it was found that treatment at non-academic facilities significantly increased the likelihood of receiving LINAC SRS over Gamma Knife SRS, especially in the Midwestern, Northeastern, and Southern US regions.

Patients receiving higher doses of radiation (18-24 Gy) were also more likely to receive LINAC SRS, and those living within 20 miles of a treatment facility had a 27% higher chance of receiving LINAC, suggesting that geographic accessibility plays a role in treatment modality choice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictors of linear accelerator versus Gamma Knife stereotactic radiosurgery use for brain metastases in the United States. McClelland Iii, S., Degnin, C., Chen, Y., et al.[2022]

Stereotactic ablative radiotherapy (SABR) is an effective treatment for early-stage non-small cell lung cancer, especially for patients who cannot undergo surgery, showing high local tumor control rates with manageable side effects.

The CyberKnife system is particularly advantageous for SABR in lung tumors due to its ability to accurately target moving tumors during breathing, enhancing treatment precision.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

CyberKnife stereotactic ablative radiotherapy for lung tumors. Gibbs, IC., Loo, BW.[2022]

Stereotactic radiosurgery (SRS) using CyberKnife is a safe and effective treatment for elderly patients (≥65 years) with brain metastases, achieving high local control rates and maintaining a stable quality of life in 97.9% of patients.

In a study of 97 patients, SRS demonstrated a 79% overall survival rate at 3 months and a 99.2% local tumor progression-free rate at 6 months, indicating its efficacy compared to traditional whole brain radiation therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of CyberKnife radiosurgery in elderly patients with brain metastases: a retrospective clinical evaluation. Acker, G., Hashemi, SM., Fuellhase, J., et al.[2021]

Stereotactic radiosurgery (SRS) is an effective salvage treatment for brain metastases in small-cell lung cancer (SCLC) patients, particularly after prior whole-brain irradiation, with a 1-year overall survival rate of 28%.

The timing of SRS after whole-brain radiation therapy significantly impacts survival, with patients receiving SRS more than one year after initial treatment showing improved overall survival (36% vs. 21% for those treated sooner).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of Gamma Knife Radiosurgery in Small Cell Lung Cancer: A Multi-Institutional Retrospective Study of the International Radiosurgery Research Foundation (IRRF). Cifarelli, CP., Vargo, JA., Fang, W., et al.[2021]

The combination of stereotactic radiosurgery (SRS) and whole-brain radiotherapy (WBRT) improves local tumor control and neurological function in patients with brain metastases, particularly benefiting those with a single metastasis, as it is associated with better survival compared to WBRT alone.

Current studies on SRS compared to other treatments like WBRT or neurosurgery show limited quality and inconclusive evidence, highlighting the need for more rigorous research to assess the effectiveness and safety of these interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Medical and health economic assessment of radiosurgery for the treatment of brain metastasis. Müller-Riemenschneider, F., Schwarzbach, C., Bockelbrink, A., et al.[2021]

Stereotactic radiosurgery was performed on 24 patients with metastatic brain tumors, showing that it effectively controlled tumor growth without the surgical risks associated with traditional craniotomy, as no patients died from treated brain metastases during the study period.

The median survival after radiosurgery was 10 months, with a 1-year survival rate of 33.3%, indicating that this treatment can be a viable option for patients with brain metastases, including those resistant to conventional therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Radiosurgery for solitary brain metastases using the cobalt-60 gamma unit: methods and results in 24 patients. Coffey, RJ., Flickinger, JC., Bissonette, DJ., et al.[2019]

References

1. England pubmed.ncbi.nlm.nih.gov

Intracranial control after Cyberknife radiosurgery to the resection bed for large brain metastases. [2018]

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

Local recurrence and survival following stereotactic radiosurgery for brain metastases from small cell lung cancer. [2016]

3. England pubmed.ncbi.nlm.nih.gov

Real-world analysis of different intracranial radiation therapies in non-small cell lung cancer patients with 1-4 brain metastases. [2022]

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

Potential role for LINAC-based stereotactic radiosurgery for the treatment of 5 or more radioresistant melanoma brain metastases. [2016]

5. England pubmed.ncbi.nlm.nih.gov

New developments in intracranial stereotactic radiotherapy for metastases. [2022]

6. Greece pubmed.ncbi.nlm.nih.gov

Stereotactic Ablative Radiotherapy Using CyberKnife for Stage I Non-small-cell Lung Cancer: A Retrospective Analysis. [2022]

7. Germany pubmed.ncbi.nlm.nih.gov

Risk-adapted robotic stereotactic body radiation therapy for inoperable early-stage non-small-cell lung cancer. [2022]

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

Predictors of linear accelerator versus Gamma Knife stereotactic radiosurgery use for brain metastases in the United States. [2022]

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

CyberKnife stereotactic ablative radiotherapy for lung tumors. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Efficacy and safety of CyberKnife radiosurgery in elderly patients with brain metastases: a retrospective clinical evaluation. [2021]

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

Role of Gamma Knife Radiosurgery in Small Cell Lung Cancer: A Multi-Institutional Retrospective Study of the International Radiosurgery Research Foundation (IRRF). [2021]

12. Germany pubmed.ncbi.nlm.nih.gov

Medical and health economic assessment of radiosurgery for the treatment of brain metastasis. [2021]

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

Radiosurgery for solitary brain metastases using the cobalt-60 gamma unit: methods and results in 24 patients. [2019]