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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method for treating small cell lung cancer that has spread to the brain. Instead of targeting the entire brain, the trial uses stereotactic radiation, which focuses radiation on each tumor while sparing surrounding brain tissue. The researchers aim to determine if this method is effective and less harmful than whole-brain radiation. Suitable candidates have small cell lung cancer with 1-10 brain tumors visible on an MRI and have not received prior brain radiation. As an unphased trial, this study offers patients the chance to explore a potentially less harmful treatment option.

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 prior data suggests that stereotactic radiation is safe for treating lung cancer with brain metastases?

Research has shown that stereotactic radiation is generally safe for treating brain tumors that have spread from other parts of the body. This focused radiation is effective and usually well-tolerated by patients. For instance, one study found that stereotactic radiosurgery (SRS) for patients with small cell lung cancer and fewer than five brain tumors effectively controlled the tumors. Another report noted that this treatment allowed patients to avoid or delay whole-brain radiation, which can have more side effects.

Overall, evidence suggests that stereotactic radiation is a safe option for many patients with brain tumors from lung cancer. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Stereotactic radiation is unique because it offers a highly precise way to target brain metastases from lung cancer. Unlike traditional whole-brain radiation, which can affect healthy brain tissue, stereotactic radiation focuses high doses of radiation directly on the tumors, sparing surrounding areas. This precision means fewer side effects and potentially better preservation of brain function. Researchers are excited about this treatment because it allows for quicker delivery—a few sessions compared to many weeks—while maintaining or even enhancing effectiveness against the tumors.

What evidence suggests that stereotactic radiation is effective for lung cancer with brain metastases?

Research has shown that stereotactic radiation, the treatment under study in this trial, can effectively treat cancer that has spread to the brain in patients with small cell lung cancer. One study found that this targeted treatment can help patients live as long as those with fewer brain tumors, even if they have up to 10 tumors. For patients with fewer than five brain tumors, this method controls the disease well. However, patients with more than five brain tumors might still face brain problems later. Overall, stereotactic radiation offers promising results as a focused treatment option, providing a more precise alternative to whole-brain treatment. ^{3 6 7 8 9}

Who Is on the Research Team?

Ayal Aizer, MD, MPH

Principal Investigator

Brigham and Women's Hospital

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9518777/

Stereotactic radiotherapy for brain metastases in patients with ... The median OS in this cohort was 6.1 months, with a 12-month survival rate of 24%, which is in the range of the median OS of 4.5–17.1 months reported previously ...

2. advancesradonc.org advancesradonc.org/article/S2452-1094(23)00066-0/fulltext

Stereotactic Radiosurgery for Brain Metastases in Patients ... SRS for SCLC in patients with <5 BM appears to offer acceptable control rates. Patients with >5 BM have high rates of subsequent brain failure ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11049204/

Prognosis versus Actual Outcomes in Stereotactic ... Recent data increasingly show that survival after SRS as an initial treatment for up to 10 brain metastases is non-inferior compared to 2–4 BMs ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2405630825001302

Prognostic factors, patterns of failure and re-irradiation in ... Hypofractionated stereotactic radiotherapy (fSRT) is increasingly used for brain metastases (BMs) from non-small cell lung cancer (NSCLC).

5. jamanetwork.com jamanetwork.com/journals/jamaoncology/fullarticle/2766565

Evaluation of First-line Radiosurgery vs Whole-Brain ... This cohort study compares the overall survival, disease progression, and other outcomes of stereotactic radiosurgery with those of ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10526239/

Modern Stereotactic Radiotherapy for Brain Metastases from ... Multiple courses of SRS to treat new BMs appeared to be safe and effective for carefully selected patients, and it allowed them to avoid or delay WBRT [75,76].

7. jamanetwork.com jamanetwork.com/journals/jamaoncology/fullarticle/2835449

Therapy, Safety, and Logistics of Preoperative vs ... In the preoperative stereotactic radiosurgery (SRS)/SRT cohort, 45 (88%) completed both treatments compared with 38 (73%) in the postoperative ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S258953702500121X

Efficacy and safety of online adaptive magnetic resonance- ... Online adaptive FSRT using a 1.5 T MR-Linac has demonstrated effectiveness and good tolerability for BMs in patients with NSCLC.

9. journals.sagepub.com journals.sagepub.com/doi/10.3233/THC-230104

Efficacy and safety analysis of stereotactic body ... Lung cancer is prone to metastasize to the brain, which is difficult for surgery and leads to poor prognosis due to poor chemotherapy efficacy.