Stereotactic Radiation for Lung Cancer with Brain Metastases

Overseen By Alexandra Gavrilovic, BA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Dana-Farber Cancer Institute

Disqualifiers: Prior brain radiation, Kidney disease, Leptomeningeal disease, others

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

Compensation: Varies

Number of Visits: 1

100 Participants Needed

Trial Summary

What is the purpose of this trial?

This research study is studying stereotactic radiation (focused/pinpoint radiation that targets each individual tumor but not the surrounding brain) instead of whole-brain radiation (radiation targeting the entire brain) as a possible treatment for patients with small cell lung cancer and 1-10 brain metastases. The intervention involved in this study is: -Stereotactic (focused, pinpoint) radiation

Do I need to stop my current medications for this trial?

The trial protocol 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 Radiation for lung cancer with brain metastases?

Research shows that stereotactic radiosurgery (a precise form of radiation therapy) can be effective for treating brain metastases in patients with non-small-cell lung cancer, potentially improving survival compared to traditional whole-brain radiotherapy. ^{1 2 3 4 5}

Is stereotactic radiation generally safe for treating lung cancer and brain metastases?

Stereotactic radiation therapy has been shown to be generally safe for treating early-stage lung cancer and brain metastases, with studies indicating an acceptable safety profile. However, tumors in ultra-central locations may have unique safety considerations. ^{3 6 7 8 9}

How is stereotactic radiation treatment different for lung cancer with brain metastases?

Stereotactic radiation, also known as stereotactic radiosurgery (SRS), is unique because it delivers a highly focused, large dose of radiation to small brain targets in a single session, minimizing damage to surrounding healthy tissue. This approach is minimally invasive, allows patients to quickly return to normal activities, and offers higher control rates of brain lesions compared to whole-brain radiotherapy (WBRT). ^{2 3 4 10 11}

Research Team

Ayal Aizer, MD, MPH

Principal Investigator

Brigham and Women's Hospital

Eligibility Criteria

This trial is for adults with small cell lung cancer who have 1-10 brain metastases visible on MRI. It's open to those who've had previous systemic therapy and possibly surgery for brain metastases, but not to those who've had prior brain radiation, can't receive gadolinium, have widespread leptomeningeal disease, more than six brain lesions, received preventive cranial radiation, severe kidney disease or inadequate mental capacity.

Inclusion Criteria

My small cell lung cancer has spread to my brain.

I have had treatment that affects my whole body.

You must have between 1 and 10 clearly visible brain lesions on an MRI scan.

Exclusion Criteria

I cannot receive gadolinium.

My kidney function is severely reduced or I am on dialysis.

My cancer has spread to the lining of my brain and spinal cord.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation Treatment

Participants receive stereotactic radiation targeting brain metastases

1-2 weeks

1-5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months

Regular visits (in-person and virtual)

Treatment Details

Interventions

• Stereotactic Radiation

Trial Overview The study tests stereotactic radiation—a precise type of radiation that targets individual tumors without affecting the surrounding brain—against traditional whole-brain radiation in treating patients with small cell lung cancer that has spread to the brain.

Participant Groups

Group I: Stereotactic Radiation Experimental Treatment 1 Intervention

* Stereotactic radiation will begin within 14 days of the MRI used for radiation planning * Lesions \<2 cm in maximum diameter will be treated with stereotactic radiosurgery, generally 20 Gy in 1 fraction * Lesions between 2.0 and 3.0 cm in maximum diameter will generally be treated to 18 Gy in 1 fraction * Lesions \>3 cm will be generally be treated with stereotactic radiotherapy to 30 Gy in 5 fractions

Who Is Running the Clinical Trial?

Dana-Farber Cancer Institute

Lead Sponsor

Trials

1,128

Recruited

382,000+

Findings from Research

In a randomized phase 2 trial involving 98 medically inoperable patients with early-stage non-small cell lung cancer, a single fraction of 30 Gy was found to be as effective as 60 Gy delivered in three fractions regarding toxicity and cancer control outcomes.

Patients receiving the single fraction treatment reported better social functioning and less dyspnea at the 6-month follow-up, suggesting that 30 Gy in 1 fraction may improve quality of life compared to the 60 Gy in 3 fractions regimen.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

One Versus Three Fractions of Stereotactic Body Radiation Therapy for Peripheral Stage I to II Non-Small Cell Lung Cancer: A Randomized, Multi-Institution, Phase 2 Trial. Singh, AK., Gomez-Suescun, JA., Stephans, KL., et al.[2021]

Stereotactic body radiotherapy (SBRT) for ultra-central lung tumors shows high efficacy, with pooled local control rates of 92% at 1 year and 89% at 2 years, based on a systematic review of 27 studies involving 1183 treated targets.

While SBRT is effective, it carries risks of severe toxicity, with a 6% incidence of grade 3-4 toxicities and a 4% incidence of treatment-related deaths, highlighting the importance of careful patient selection and treatment planning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic body radiotherapy for Ultra-Central lung Tumors: A systematic review and Meta-Analysis and International Stereotactic Radiosurgery Society practice guidelines. Yan, M., Louie, AV., Kotecha, R., et al.[2023]

Stereotactic body radiation therapy (SBRT) demonstrated a 3-year overall survival rate of 59.9% for inoperable patients and 76.5% for operable patients with T1N0M0 non-small cell lung cancer, indicating its efficacy as a treatment option.

The treatment was associated with low rates of severe toxicities, with only 10 patients experiencing grade 3 and 2 patients experiencing grade 4 toxicities, suggesting that SBRT is a safe alternative to surgery for early-stage lung cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective Trial of Stereotactic Body Radiation Therapy for Both Operable and Inoperable T1N0M0 Non-Small Cell Lung Cancer: Japan Clinical Oncology Group Study JCOG0403. Nagata, Y., Hiraoka, M., Shibata, T., et al.[2022]

Out of 40,803 patients with brain metastases from non-small cell lung cancer, 83.8% received whole brain radiation therapy (WBRT), while only 16.2% were treated with stereotactic radiosurgery (SRS), indicating that WBRT is still the predominant treatment method.

The use of SRS has significantly increased from 7% in 2004 to 37% in 2014, with factors such as the year of diagnosis, type of facility (academic vs. community), and insurance status influencing the likelihood of receiving SRS over WBRT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Disparities in the Use of Single-fraction Stereotactic Radiosurgery for the Treatment of Brain Metastases From Non-small Cell Lung Cancer. Modh, A., Doshi, A., Burmeister, C., et al.[2023]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Treatment of brain metastasis from lung cancer. [2023]

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

Upfront and Repeated Stereotactic Radiosurgery in Patients With Brain Metastases From NSCLC. [2023]

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

Radiosurgery for brain metastases from primary lung carcinoma. [2004]

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

Comparative survival in patients with brain metastases from non-small-cell lung cancer treated before and after implementation of radiosurgery. [2019]

5. Turkey pubmed.ncbi.nlm.nih.gov

Stereotactic Radiosurgery Results in Non-Small-Cell Lung Cancer Patients with Brain Metastases in the Era of Modern Systemic Treatment Agents. [2023]

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

One Versus Three Fractions of Stereotactic Body Radiation Therapy for Peripheral Stage I to II Non-Small Cell Lung Cancer: A Randomized, Multi-Institution, Phase 2 Trial. [2021]

7. Ireland pubmed.ncbi.nlm.nih.gov

Stereotactic body radiotherapy for Ultra-Central lung Tumors: A systematic review and Meta-Analysis and International Stereotactic Radiosurgery Society practice guidelines. [2023]

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

Phase I/II Study of Stereotactic Body Radiation Therapy for Pulmonary Metastases in Pediatric Patients. [2022]

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

Prospective Trial of Stereotactic Body Radiation Therapy for Both Operable and Inoperable T1N0M0 Non-Small Cell Lung Cancer: Japan Clinical Oncology Group Study JCOG0403. [2022]

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

Radiosurgery and radiotherapy for non-small-cell lung cancer metastatic to brain. [2019]

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

Disparities in the Use of Single-fraction Stereotactic Radiosurgery for the Treatment of Brain Metastases From Non-small Cell Lung Cancer. [2023]