Post-Surgery Stereotactic Body Radiation for Lung Cancer

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Roswell Park Cancer Institute

Disqualifiers: Pregnancy, Prior radiation, Contraindication to SBRT, 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: 5

Duration: 1-2 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the side effects of a specialized radiation treatment for patients who have undergone surgery for non-small cell lung cancer. Traditional radiation can damage healthy lung tissue, but this new method, called stereotactic body radiation therapy (also known as Stereotactic Ablative Radiotherapy or CyberKnife), targets cancer cells more precisely with fewer sessions. The goal is to eliminate remaining cancer cells while minimizing harm to healthy tissue. This trial may suit those who have had lung cancer surgery and have a close or positive surgical margin, indicating possible remaining cancer cells. As a Phase 1 trial, this research focuses on understanding the treatment's effects in people, offering participants the opportunity to be among the first to receive this innovative therapy.

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

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 prior data suggests that stereotactic body radiation therapy is safe for post-surgery lung cancer patients?

Research has shown that stereotactic body radiation therapy (SBRT) is generally easy for patients to handle. In studies, patients with small lung tumors experienced fewer short-term side effects with SBRT compared to surgery, suggesting that SBRT might be gentler on the body in the short term. Other research indicates that SBRT can be safely used even in difficult-to-reach lung areas, as the treatment precisely targets the tumor to avoid harming healthy tissue. Overall, these findings support the safety of SBRT for treating lung cancer after surgery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Stereotactic Body Radiation Therapy (SBRT) for post-surgery lung cancer treatment because it offers a targeted approach that minimizes damage to surrounding healthy tissues. Unlike traditional radiation therapy, which often involves multiple sessions over several weeks, SBRT can deliver precise, high doses in a single or just a few sessions. This method not only potentially reduces treatment time but also aims to improve patient recovery and quality of life by preserving more lung function. The precision of SBRT in targeting cancer cells while sparing healthy tissue is a promising advancement in post-surgical cancer care.

What evidence suggests that stereotactic body radiation therapy is effective for non-small cell lung cancer?

Studies have shown that stereotactic body radiation therapy (SBRT), which participants in this trial will receive, effectively treats early-stage non-small cell lung cancer. Research indicates that SBRT targets tumors with high precision, minimizing harm to nearby healthy lung tissue. In one study, SBRT effectively controlled tumor growth over time. Patients receiving SBRT often experience fewer side effects compared to traditional radiation methods. This precise approach allows for powerful doses in fewer sessions, potentially improving recovery and quality of life. ^{4 5 6 7 8}

Who Is on the Research Team?

Anurag K. Singh

Principal Investigator

Roswell Park Cancer Institute

Are You a Good Fit for This Trial?

This trial is for adults with non-small cell lung cancer who've had surgery to remove it but might still have some cancer cells near the edges of where the tumor was or in certain lymph nodes. They should be able to do most activities on their own (ECOG <=2) and agree to birth control if they can have children. People can't join if they're pregnant, nursing, had prior radiation in that area, can't stay still for treatment, or are unable to follow study rules.

Inclusion Criteria

I can take care of myself and am up and about more than half of my waking hours.

I had surgery for lung cancer with specific conditions met regarding the margins and lymph nodes.

I am using or willing to use birth control or practice abstinence.

Exclusion Criteria

Unwilling or unable to follow protocol requirements

My doctor thinks I can't safely join the study.

I had a partial lung surgery without full lymph node examination.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients undergo 1 fraction (or 5 fractions every other day if R2 resection of central tumor) of SBRT beginning at least 2 weeks after surgical resection

1-2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 years

Follow-up at 5 and 12 weeks, then periodically up to 5 years

What Are the Treatments Tested in This Trial?

Interventions

• Stereotactic Body Radiation Therapy

Trial Overview The trial tests a single high-dose radiation treatment called Stereotactic Body Radiation Therapy (SBRT) after lung cancer surgery. It's designed to see if one big dose can kill leftover cancer cells without harming too much healthy tissue. Patients will also fill out questionnaires about their quality of life before and after treatment.

How Is the Trial Designed?

Group I: Treatment (SBRT) Experimental Treatment 3 Interventions

Beginning at least 2 weeks after surgical resection, patients undergo 1 fraction (or 5 fractions every other day if R2 resection of central tumor) of SBRT.

Who Is Running the Clinical Trial?

Roswell Park Cancer Institute

Lead Sponsor

Trials

427

Recruited

40,500+

Published Research Related to This Trial

In a study of 73 patients with metastatic lung tumors treated using the CyberKnife system, stereotactic ablative body radiotherapy (SABR) demonstrated high effectiveness, achieving a 2-year local control rate of 89.1% and an overall survival rate of 71.3%.

The treatment was associated with acceptable toxicity levels, with only two cases of grade 2 or higher radiation pneumonitis, indicating that SABR with a central high dose is a safe option for managing metastatic lung tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic ablative body radiotherapy with a central high dose using CyberKnife for metastatic lung tumors. Hayashi, K., Suzuki, O., Shiomi, H., et al.[2023]

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]

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 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]

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 100 patients with early-stage non-small cell lung cancer (NSCLC) treated with stereotactic ablative body radiotherapy (SABR), the 1-, 2-, and 3-year local control rates were 100%, 93.55%, and 84.33%, respectively, indicating high efficacy in tumor control.

The treatment was associated with low toxicity, with only 2% of patients experiencing Grade-3 side effects, suggesting that SABR is a safe option for patients who are inoperable or refuse surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Definitive Treatment of Early-Stage Non-Small Cell Lung Cancer with Stereotactic Ablative Body Radiotherapy in a Community Cancer Center Setting. Heal, C., Ding, W., Lamond, J., et al.[2020]

Stereotactic ablative radiotherapy (SABR) has rapidly expanded in clinical use for treating various primary and metastatic tumors, demonstrating promising results in tumor control.

Despite its effectiveness, SABR can lead to serious complications, highlighting the need for strategies to reduce these risks and improve the safety of the treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Serious complications associated with stereotactic ablative radiotherapy and strategies to mitigate the risk. Lo, SS., Sahgal, A., Chang, EL., et al.[2018]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40764573/

A prospective outcomes and cost-effective analysis ... A prospective outcomes and cost-effective analysis of surgery compared to stereotactic body radiation therapy for stage I non-small cell lung ...

2. ro-journal.biomedcentral.com ro-journal.biomedcentral.com/articles/10.1186/s13014-025-02699-4

A prospective outcomes and cost-effective analysis of surgery ... A prospective outcomes and cost-effective analysis of surgery compared to stereotactic body radiation therapy for stage I non-small cell lung ...

3. tlcr.amegroups.org tlcr.amegroups.org/article/view/43005/html

Four-year follow-up outcomes after stereotactic body radiation ... Conclusions: SBRT with a BED 100 Gy in 4–10 fractions is effective and acceptable for treating patients with central early-stage NSCLC. Further studies are ...

4. por-journal.com por-journal.com/journals/pathology-and-oncology-research/articles/10.3389/pore.2024.1611709/full

Stereotactic body radiotherapy in lung cancer The purpose of this study is to summarize the current developments, randomised studies, guidelines about lung SBRT, with emphasis on the possibility of ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6318482/

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.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9118536/

Safety and Efficacy of Stereotactic Ablative Radiotherapy for ... Stereotactic ablative radiotherapy (SABR) or stereotactic body radiotherapy (SBRT) obviously improved the clinical efficacy and survival of UCLC patients.

7. astro.org astro.org/news-and-publications/news-and-media-center/news-releases/2025/ten-year-clinical-trial-report-finds-radiation-comparable-to-surgery-for-early-stage-nsclc

Ten-year clinical trial report finds radiation comparable to ... Patients with small tumors also experienced fewer short-term side effects after stereotactic radiation compared to lobectomy.

8. sciencedirect.com sciencedirect.com/science/article/pii/S036030162400508X

Safety and Efficacy of Stereotactic Body Radiation Therapy ... Our study suggests that homogenously prescribed SBRT can be safely and effectively used for ultracentral thoracic lesions.