SBRT for Non-Small Cell Lung Cancer

Overseen By ASK RPCI

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Roswell Park Cancer Institute

Must not be taking: Chemotherapy, Biological therapy

Disqualifiers: Brain metastases, Uncontrolled illness, others

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

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a single session of targeted radiation, known as Stereotactic Body Radiation Therapy (SBRT), can be as safe and effective as multiple sessions for individuals with non-small cell lung cancer. The focus is on tumors near critical structures like the heart and esophagus. It suits those with non-small cell lung cancer who have tumors smaller than 6 cm and are either unsuitable for surgery or have opted against it. As an unphased trial, this study provides patients the opportunity to contribute to innovative research that could simplify and enhance future cancer treatments.

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

The trial protocol does not specify if you need to stop taking your current medications, but you cannot have any systemic therapy (like chemotherapy) 4-6 weeks before, during, or 2 weeks after the radiation treatment.

What prior data suggests that SBRT is safe for treating non-small cell lung cancer?

Research shows that SBRT, a type of precise radiation therapy, is generally safe for people with non-small cell lung cancer. Studies have found that patients experience fewer harmful side effects, which are unwanted reactions to treatment. One review described SBRT as a standard treatment for early-stage lung cancer due to its safety and effectiveness. Another study noted that patients had good survival rates with few side effects, indicating the treatment is well-tolerated. Overall, SBRT has a strong record of safety in treating lung cancer. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Stereotactic Body Radiation Therapy (SBRT) is unique because it delivers a high dose of radiation in a single, precise fraction, targeting lung tumors with pinpoint accuracy. Unlike traditional radiation therapy, which often requires multiple low-dose sessions over several weeks, SBRT minimizes exposure to surrounding healthy tissues and reduces treatment time significantly. Researchers are excited about SBRT because it has the potential to improve patient outcomes by offering a quicker, more focused treatment option, potentially leading to fewer side effects and better quality of life for individuals with non-small cell lung cancer.

What evidence suggests that SBRT might be an effective treatment for non-small cell lung cancer?

Research has shown that Stereotactic Body Radiation Therapy (SBRT), which participants in this trial will receive, is a promising treatment for non-small cell lung cancer. One study found that SBRT improves cancer control and increases survival rates in patients with early-stage non-small cell lung cancer (NSCLC). Another analysis showed that the treatment has low side effects, meaning patients generally tolerate it well. SBRT is considered a breakthrough for treating early-stage NSCLC because it delivers high doses of radiation directly to the tumor in fewer sessions. Evidence suggests that SBRT is both effective and safe for treating this type of lung cancer. ^{1 2 6 7 8}

Who Is on the Research Team?

Anurag Singh, MD

Principal Investigator

Roswell Park Comprehensive Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults with a confirmed diagnosis of central non-small cell lung cancer (NSCLC) that's in an early stage and smaller than 6 cm. They should be unable to have or refuse surgery, not pregnant, and haven't had recent chemotherapy or radiation. Participants must understand the study's experimental nature and agree to use birth control if they can have children.

Inclusion Criteria

I cannot or choose not to have surgery for my condition.

Participants of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry.

I am able to get out of my bed or chair and move around.

Exclusion Criteria

I do not have any severe illnesses or social situations that would stop me from following the study's requirements.

I do not have brain metastases.

I haven't had chemotherapy or radiotherapy in the last 4 weeks, or I've recovered from its side effects.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation

Participants receive a single fraction of targeted Stereotactic Body Radiation Therapy (SBRT)

1 day

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 5 years

What Are the Treatments Tested in This Trial?

Interventions

• SBRT

Trial Overview The study tests whether one session of targeted radiation therapy (SBRT) is as effective and safe as multiple sessions for treating central NSCLC. It aims to see if this single treatment can help patients who are not candidates for surgery.

How Is the Trial Designed?

Group I: Stereotactic Body Radiation Therapy (SBRT) Experimental Treatment 1 Intervention

A single fraction of targeted SBRT

SBRT is already approved in United States, European Union, Canada, Japan for the following indications:

Approved in United States as SBRT for:

• Prostate cancer
• Lung cancer
• Liver cancer
• Pancreatic cancer
• Spinal tumors

Approved in European Union as SBRT for:

• Prostate cancer
• Lung cancer
• Liver cancer
• Pancreatic cancer
• Spinal tumors
• Bone metastases

Approved in Canada as SBRT for:

• Prostate cancer
• Lung cancer
• Liver cancer
• Pancreatic cancer
• Spinal tumors

Approved in Japan as SBRT for:

• Prostate cancer
• Lung cancer
• Liver cancer
• Pancreatic cancer

Who Is Running the Clinical Trial?

Roswell Park Cancer Institute

Lead Sponsor

Trials

427

Recruited

40,500+

Published Research Related to This Trial

Stereotactic ablative body radiotherapy (SABR) is a significant advancement in radiotherapy that has been shown to improve tumor control and overall survival in patients with lung tumors.

The review highlights the current evidence supporting the efficacy of SABR for both primary and secondary lung tumors, along with ongoing trials that may further validate its benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic ablative body radiotherapy (SABR) for primary and secondary lung tumours. Goldsmith, C., Gaya, A.[2022]

Stereotactic body radiation therapy (SBRT) is a preferred treatment for early-stage non-small cell lung cancer (NSCLC) patients who cannot undergo surgery, but accurate lymph node staging is crucial for optimal patient selection.

Current staging methods like PET/CT and EBUS have limited sensitivity in detecting lymph node metastases, which can lead to undetected cancer spread and poorer outcomes; thus, invasive staging procedures are often necessary to improve detection and potentially enhance survival with adjuvant therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Undetected lymph node metastases in presumed early stage NSCLC SABR patients. Cerra-Franco, A., Diab, K., Lautenschlaeger, T.[2017]

Stereotactic body radiotherapy (SBRT) is effective for treating early-stage non-small cell lung cancer (NSCLC) in patients who cannot undergo surgery, showing good outcomes and low toxicity for tumors located in the periphery.

However, the risk of severe toxicity increases for tumors near critical structures like the bronchial tree or mediastinum, highlighting the importance of careful dose-fractionation planning in these cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An optimal dose-fractionation for stereotactic body radiotherapy in peripherally, centrally and ultracentrally located early-stage non-small lung cancer. Zarębska, I., Harat, M.[2023]

Stereotactic ablative radiation therapy (SABR) for lung oligometastases shows promising safety and efficacy, with a 24-month overall survival rate of 74.6% and minimal toxicity, as only one significant adverse event was reported among 77 patients studied over an average follow-up of 22 months.

Colorectal metastases exhibited a notably higher local failure rate compared to other types of tumors, suggesting they may be more resistant to SABR, indicating a need for potential dose escalation strategies for these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Colorectal Histology Is Associated With an Increased Risk of Local Failure in Lung Metastases Treated With Stereotactic Ablative Radiation Therapy. Binkley, MS., Trakul, N., Jacobs, LR., et al.[2022]

The TROG 13.01/ALTG 13.001 clinical trial is investigating the safety and efficacy of single versus multi-fraction stereotactic ablative body radiotherapy (SABR) for lung tumors in 84 patients with up to three metastases, aiming to determine the best treatment approach for pulmonary oligometastases.

The study will compare a single high dose of 28Gy to a total of 48Gy delivered in four fractions, assessing not only safety but also quality of life, survival rates, and potential cost implications of each treatment method.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomised phase II trial of Stereotactic Ablative Fractionated radiotherapy versus Radiosurgery for Oligometastatic Neoplasia to the lung (TROG 13.01 SAFRON II). Siva, S., Kron, T., Bressel, M., et al.[2022]

Stereotactic ablative radiotherapy (SABR) is an effective treatment for early-stage non-small cell lung cancers (NSCLCs) that are medically inoperable, providing local control and toxicity levels comparable to surgical resection.

SABR is gaining interest as a noninvasive treatment option for patients with borderline resectable lung cancers, although further randomized studies are needed to evaluate its survival benefits in operable patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic ablative radiotherapy (SABR) for non-small cell lung cancer. Iyengar, P., Westover, K., Timmerman, RD.[2013]

In a multicenter phase 3 trial involving 101 patients with inoperable stage 1 non-small-cell lung cancer, stereotactic ablative body radiotherapy (SABR) demonstrated significantly better local control compared to standard radiotherapy, with a 68% reduction in the risk of local treatment failure (hazard ratio 0.32).

SABR was associated with a similar safety profile to standard radiotherapy, showing no increase in major toxicity, making it a preferred treatment option for patients with this type of lung cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic ablative radiotherapy versus standard radiotherapy in stage 1 non-small-cell lung cancer (TROG 09.02 CHISEL): a phase 3, open-label, randomised controlled trial. Ball, D., Mai, GT., Vinod, S., et al.[2022]

In a study of 53 patients with lung tumors ≥5 cm treated with SABR, 30% experienced severe toxicity (grade ≥3), highlighting the need for improved treatment planning to reduce risks.

Using a knowledge-based planning model, researchers found that nearly 50% of the treatment plans for patients with severe toxicity could have been improved, particularly in terms of lung dose exposure, suggesting that model-based quality assurance could enhance safety in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Knowledge-Based Planning for Identifying High-Risk Stereotactic Ablative Radiation Therapy Treatment Plans for Lung Tumors Larger Than 5 cm. Hof, SV., Delaney, AR., Tekatli, H., et al.[2019]

Lung stereotactic body radiation therapy (SBRT) is an effective treatment option for early-stage non-small cell lung cancer (NSCLC) and is increasingly being used for more advanced cases.

The review highlights current treatment recommendations and planning for SBRT, indicating its growing role in managing lung cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lung Stereotactic Body Radiation Therapy. Rehman, S., Roach, MC., Bradley, JD., et al.[2018]

Stereotactic ablative body radiotherapy (SABR) is now the standard treatment for early-stage non-small-cell lung cancer (NSCLC) in patients who cannot undergo surgery, highlighting its efficacy in this patient population.

The review also discusses the safety profile of SABR, including reported toxicity rates, and explores its potential use in combination with other therapies for improved outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review of outcomes following stereotactic ablative radiotherapy in the treatment of early-stage primary lung cancer. Murray, P., Franks, K., Hanna, GG.[2022]

In a study of 39 patients with 45 lung lesions treated with stereotactic ablative body radiotherapy (SBRT), local progression-free survival rates were high, with 90.5% at 1 year and 80.5% at 2 years, indicating effective tumor control.

The treatment was well-tolerated with only mild acute side effects, suggesting that the moderate dose schedules of 35 Gy (5 fractions) or 37.5 Gy (3 fractions) are safe and effective for managing non-small cell lung cancer and metastases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic ablative radiotherapy for small lung tumors with a moderate dose. Favorable results and low toxicity. Duncker-Rohr, V., Nestle, U., Momm, F., et al.[2022]

The introduction of stereotactic ablative body radiotherapy (SABR) for stage I non-small-cell lung cancer (NSCLC) at a Scottish cancer center has led to improved median survival rates, increasing from 32.5 months before SABR was available to 48.8 months after its establishment.

SABR has not only improved survival outcomes but also increased the proportion of patients receiving radical therapy, particularly among younger and healthier patients, indicating its effectiveness as a treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-World Impact of SABR on Stage I Non-Small-Cell Lung Cancer Outcomes at a Scottish Cancer Centre. Stares, M., Lewis, G., Vallet, M., et al.[2023]

The iSABR trial demonstrated that individualized stereotactic ablative radiotherapy (SABR) for lung tumors resulted in high local control rates, with freedom from local recurrence at 1 year ranging from 94% to 97% across different patient groups.

The trial showed a low incidence of severe toxic effects (only 5%), indicating that personalized dosing strategies can minimize risks while maintaining effective treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Individualized Stereotactic Ablative Radiotherapy for Lung Tumors: The iSABR Phase 2 Nonrandomized Controlled Trial. Gensheimer, MF., Gee, H., Shirato, H., et al.[2023]

Citations

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Stereotactic body radiation therapy for non-small cell lung ... This literature review provides an updated analysis of prospective clinical trials evaluating clinical outcomes following SBRT for early stage NSCLC.

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0167814024007096

Stereotactic ablative radiotherapy for locally advanced non ... This meta-analysis presents promising findings regarding LC and OS rates, while also observing low toxicity rates, indicating the potential feasibility of SABR ...

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Stereotactic ablative radiotherapy for stage I NSCLC The results of SABR for early-stage non-small cell lung cancer (NSCLC) arguably represent one of most significant breakthroughs in curative therapy of lung ...

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Historical Versus Modern Data of Stereotactic Ablative ... Stereotactic ablative radiotherapy for operable stage I non-small-cell lung cancer (revised STARS): long-term results of a single-arm, prospective trial

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NCT05291780 | Stereotactic Ablative Radiotherapy in ... This is a prospective, non-randomized, single arm, single institution phase II trial to evaluate the safety and effectiveness of stereoractic ablative ...

6. jamanetwork.com jamanetwork.com/journals/jamaoncology/fullarticle/2815670

Stereotactic Radiation Therapy in Early Non–Small Cell ... This phase 2 nonrandomized clinical trial enrolled 39 patients who were treated with SABR. Median overall survival was 25 months, significantly exceeding the ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8107760/

Stereotactic radiotherapy for early stage non-small cell lung ... SBRT has been proven to be a safe, effective and efficient treatment for early stage non-small cell lung cancer (NSCLC) and is presently considered the standard ...

8. redjournal.org redjournal.org/article/S0360-3016(24)00480-2/fulltext

Stereotactic Radiation for Ultra-Central Non-Small Cell ... This study (NCT03306680) aimed to determine the maximally tolerated dose of stereotactic body radiation therapy for ultracentral non-small cell ...