Radiation Therapy Techniques for Lung Cancer

Overseen By Jenna Gregory, RN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Atrium Health

Must not be taking: Antibiotics, Steroids

Disqualifiers: Prior chest radiation, Active pulmonary infection, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 2 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two techniques for delivering breath-hold SBRT, a focused radiation therapy for lung cancer. It compares using SGRT, a precise positioning system, alone or with small markers (fiducials) that guide radiation directly to the tumor. The goal is to determine which method is more effective and safe. Individuals with non-small cell lung cancer or lung metastasis, whose tumors move with breathing, might be suitable candidates. As an unphased trial, this study allows patients to contribute to innovative research that could enhance future lung cancer treatments.

Will I have to stop taking my current medications?

If you are receiving systemic chemotherapy or other systemic agents, you must stop taking them during the SBRT treatments.

What prior data suggests that these radiation therapy techniques are safe for lung cancer treatment?

Research has shown that breath hold SBRT, a type of focused radiation therapy, is usually well-tolerated for lung cancer treatment. Studies have found that advanced imaging and techniques to manage movement can enhance the safety and effectiveness of this treatment. These methods aim the radiation more precisely at cancer cells, reducing the risk of damaging healthy tissue.

For SGRT, another type of radiation therapy, research suggests it can improve safety by preventing mistakes during treatment. It accurately tracks the patient's position, ensuring the radiation targets the correct area.

Overall, these findings suggest that the breath hold SBRT and SGRT techniques used in this trial are expected to be safe for participants. However, individual differences exist, so discussing any concerns with a doctor is important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these radiation therapy techniques for lung cancer because they integrate advanced methods to enhance precision and reduce damage to healthy tissue. Unlike traditional radiation therapies, these techniques use SBRT (Stereotactic Body Radiation Therapy) with SGRT (Surface Guided Radiation Therapy) to improve targeting accuracy. The breath hold SBRT method further minimizes lung movement during treatment, allowing for more precise radiation delivery. Additionally, the combination with implanted fiducials offers an extra layer of precision, potentially leading to better outcomes and fewer side effects.

What evidence suggests that this trial's techniques could be effective for lung cancer?

Studies have shown that Stereotactic Body Radiation Therapy (SBRT) for lung cancer effectively stops cancer growth in the treated area, with about 90% success. Research indicates that patients receiving SBRT have a 5-year survival rate between 43% and 83%. In this trial, participants will receive different combinations of SBRT and Surface Guided Radiation Therapy (SGRT). Some groups will receive free-breathing SBRT with SGRT, while others will receive breath-hold SBRT with SGRT, with or without implanted fiducials. Combining SBRT with SGRT can better target the cancer, protecting healthy tissues. SGRT helps manage body movement during treatment, increasing precision. Overall, using SBRT and SGRT together shows promising results for treating lung cancer. ^{3 6 7 8 9}

Who Is on the Research Team?

John Heinzerling, MD

Principal Investigator

Wake Forest University Health Sciences

Are You a Good Fit for This Trial?

This trial is for adults over 18 with certain types of lung cancer or tumors that move when they breathe. They must be able to follow the study plan and use effective birth control if needed. People can't join if they've had chest radiation before, have an active lung infection or pneumonitis, or were treated for pneumonitis within the last 15 days.

Inclusion Criteria

I am currently on chemotherapy or other treatments but can stop them for SBRT.

My tumor is 7 cm or smaller, confirmed or suspected to be cancer.

I can take care of myself but might not be able to do heavy physical work.

Exclusion Criteria

I am currently being treated for a lung infection or inflammation.

I have had radiation to the chest in the same area before.

I was treated for lung inflammation from a drug or therapy within the last 15 days.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive SBRT treatment with or without fiducials for breath hold techniques

2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Long-term follow-up

Participants are monitored for overall survival and local control of treated tumors

up to 5 years

What Are the Treatments Tested in This Trial?

Interventions

• Breath Hold SBRT
• SGRT

Trial Overview The study compares two ways to do SBRT (a type of radiation therapy) during breath holds for treating lung issues. One way uses SGRT with implanted markers called fiducials; the other just uses SGRT without these markers.

How Is the Trial Designed?

Group I: Group 3 Experimental Treatment 1 Intervention

Breath hold SBRT with SGRT in combination with implanted fiducials

Group II: Group 2 Experimental Treatment 1 Intervention

Breath hold SBRT with SGRT

Group III: Group 1 Experimental Treatment 1 Intervention

Freebreathing SBRT with SGRT

Who Is Running the Clinical Trial?

Atrium Health

Lead Sponsor

Trials

122

Recruited

34,900+

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

Atrium Health Levine Cancer Institute

Collaborator

Trials

30

Recruited

4,700+

Published Research Related to This Trial

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/PMC12454274/

Dosimetric and treatment efficiency comparison of lung ... FB had the shortest on-table time (13.6 min), whereas DIBH and RG demonstrated comparable treatment efficiency (22.3 vs. 22.7 min). •. Results ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4990666/

Stereotactic body radiotherapy: current strategies and future ... The reported local control rate in various prospective studies was about 90% and the 5-year overall survival ranged from 43% to 83% (18-23) (Table 1). Table 1.

3. sciencedirect.com sciencedirect.com/science/article/pii/S1879850024002753

Stereotactic Body Radiation Therapy for Primary Lung ... This case-based discussion provides a practical framework for delivering SBRT to challenging, yet frequently encountered, cases in radiation oncology.

4. spandidos-publications.com spandidos-publications.com/10.3892/ol.2025.15161/download

Application of respiratory motion management technology ... Respiratory‑induced tumor motion is a major obstacle in the precise delivery of stereotactic body radio‑ therapy (SBRT) for lung cancer, often leading to ...

5. intechopen.com intechopen.com/online-first/1229549

Stereotactic Body Radiation Therapy (SBRT) for the ... [17] combining data from the STARS and ROSEL trials reported a 3-year recurrence-free survival (RFS) of 86% for SBRT and 80% for surgery (p = 0.54). Notably, 3- ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12235356/

Application of respiratory motion management technology for ... The integration of respiratory motion management with advanced imaging is essential for optimizing therapeutic outcomes and safety in lung SBRT. Keywords: ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2452109425001939

Safety and Efficacy of Stereotactic MR-Guided Adaptive ... Between 2020 and 2023, 11 patients with 18 ultracentral NSCLC lesions underwent SMART. All treatments were delivered in breath-hold. The median ...

8. nature.com nature.com/articles/s41598-023-37643-7

Stereotactic body radiation therapy for stage I medically ... In the SBRT group, recurrence-free survival at 3 years was 86% (95% CI 74–100), whereas 80% (65–97) in the surgery group (HR 0·69 [95% CI 0.21– ...

9. redjournal.org redjournal.org/article/S0360-3016(20)33795-0/fulltext

Lung Stereotactic Body Radiation Using Deep Inspiratory ... This study demonstrates the feasibility and advantages of SBRT treatment planning with DIBH. PTV volumes in FB were significantly larger due to ...