Radiation Therapy + Surgery for Lung Cancer

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Roswell Park Cancer Institute

Disqualifiers: Stage IIIb, Active infection, Pregnancy, 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: 8

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness of a special type of radiation called stereotactic body radiation therapy (also known as Stereotactic Ablative Radiotherapy or CyberKnife) when used before surgery to treat non-small cell lung cancer. The researchers aim to determine if this approach can precisely target tumors while minimizing damage to healthy tissue. Participants will receive varying doses of this radiation, followed by surgery, to identify the best treatment combination. The trial seeks individuals with stage I-IIIA non-small cell lung cancer who can undergo surgery. As an Early Phase 1 trial, this research focuses on understanding how this new treatment works in people, offering participants the opportunity to be among the first to receive it.

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

The trial protocol does not specify whether you need to stop taking your current medications. However, it does mention that you cannot receive other cancer treatments while participating, except for certain pre-approved therapies.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that stereotactic body radiation therapy (SBRT) is generally safe for treating lung cancer. Studies have found that SBRT works well for both central and peripheral lung tumors, with no major differences in results. For very central lung cancer, SBRT is considered safe, with severe side effects being rare. One study confirmed that serious short-term side effects were uncommon after SBRT for early-stage non-small cell lung cancer.

These findings encourage those considering participation in a clinical trial using SBRT. Although this trial is in an early phase, meaning safety data is still being gathered, past research suggests that SBRT is usually well-tolerated with few serious side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about this trial because it explores the combination of Stereotactic Body Radiation Therapy (SBRT) and surgery in treating early-stage and more advanced lung cancer. Unlike traditional radiation therapy, SBRT delivers highly focused radiation doses in just a few sessions, which may reduce treatment time and minimize damage to surrounding healthy tissue. This trial examines varying doses of SBRT, including the lowest and highest doses, to see how they perform alongside surgery in different lung cancer stages and locations. By optimizing radiation dosage and combining it with surgery, researchers hope to improve outcomes and potentially offer a more effective treatment strategy for lung cancer patients.

What evidence suggests that this trial's treatments could be effective for non-small cell lung cancer?

Research has shown that stereotactic body radiation therapy (SBRT) can safely and effectively treat non-small cell lung cancer (NSCLC). Studies have found that SBRT delivers a precise, high dose of radiation directly to the tumor, protecting the surrounding healthy tissue. For patients with stage I NSCLC, SBRT has demonstrated results similar to traditional radiation treatments. Early research suggests that SBRT might also benefit patients with more advanced lung cancer, such as stage IIIA. In this trial, participants will receive different doses of SBRT followed by surgery, depending on their specific study arm. These promising findings indicate that SBRT could be a valuable option for treating NSCLC, especially when combined with surgery. ^{1 6 7 8 9}

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 patients with stage I-IIIA non-small cell lung cancer who can undergo surgery. They must understand the study, have been cleared for surgery, agree to use contraception if of child-bearing potential, and have an ECOG status of <=2. Excluded are those unable to cooperate with SBRT treatment, on other antineoplastic therapies (except neoadjuvant therapy), or with certain prior treatments.

Inclusion Criteria

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

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

I had chemotherapy for another cancer but have been cancer-free for over 3 years.

Exclusion Criteria

Any condition which in the investigator’s opinion deems the participant ineligible

My cancer is at stage IIIb.

I do not have any ongoing infections.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation

Participants undergo a single fraction of stereotactic body radiation therapy (SBRT)

1 day

1 visit (in-person)

Surgery

Participants undergo thoracic surgery

4 weeks after radiation

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 5 years

Visits at 6, 9, and 12 months, every 6 months for 2 years, then annually for 2 years

What Are the Treatments Tested in This Trial?

Interventions

• Stereotactic Body Radiation Therapy
• Thoracic Surgical Procedure

Trial Overview The trial tests stereotactic body radiation therapy followed by surgery in treating early-stage lung cancer. It aims to see how precisely targeting high-dose radiation at the tumor before surgical removal affects outcomes while minimizing damage to healthy tissue.

How Is the Trial Designed?

Group I: Study 3 (lowest- or higher-dose of SBRT, surgery) Experimental Treatment 4 Interventions

Patients with stage IIIA NSCLC in the any lung location undergo lowest- or higher-dose of Stereotactic Body Radiation Therapy over a single treatment fraction on day 1. Patients then undergo thoracic surgery on day 28.

Group II: Study 2 (lowest-dose of SBRT, surgery) Experimental Treatment 4 Interventions

Patients with stage I or II NSCLC in the central lung undergo lowest-dose of Stereotactic Body Radiation Therapy over a single treatment fraction on day 1. Patients then undergo thoracic surgery on day 28.

Group III: Study 1 (highest-dose of SBRT, surgery) Experimental Treatment 4 Interventions

Patients with stage I or II NSCLC in the peripheral lung undergo highest-dose of Stereotactic Body Radiation Therapy over a single treatment fraction on day 1. Patients then undergo thoracic surgery on day 28.

Stereotactic Body Radiation Therapy is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Stereotactic Body Radiation Therapy for:

• Non-small cell lung cancer (NSCLC)
• Melanoma
• Renal cell carcinoma (RCC)
• Prostate cancer
• Oligoprogressive cancers

Approved in European Union as Stereotactic Body Radiation Therapy for:

• Non-small cell lung cancer (NSCLC)
• Melanoma
• Renal cell carcinoma (RCC)
• Prostate cancer
• Oligoprogressive cancers

Approved in Canada as Stereotactic Body Radiation Therapy for:

• Non-small cell lung cancer (NSCLC)
• Melanoma
• Renal cell carcinoma (RCC)
• Prostate cancer
• Oligoprogressive cancers

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 radiation therapy (SABR) was found to be effective for treating pulmonary metastases, with a median follow-up of 23 months showing improved overall survival (OS) for patients with 3 or fewer metastases compared to those with more (74.2% vs. 59.3% at 24 months).

Patients with less responsive primary tumors (like adrenal or pancreatic cancers) had higher local failure rates, suggesting that higher doses of SABR or surgical options may be necessary for these cases to improve treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic ablative radiation therapy for pulmonary metastases: Improving overall survival and identifying subgroups at high risk of local failure. Pasalic, D., Lu, Y., Betancourt-Cuellar, SL., et al.[2021]

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]

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]

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]

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

Stereotactic body radiation therapy for non-small cell lung ... No differences in outcomes were observed between conventionally fractionated radiation therapy and SBRT, central and peripheral lung tumors, or inoperable and ...

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

Stereotactic body radiation therapy for stage I medically ... The results of the current study suggest that SBRT might be a safe and effective treatment modality for medically operable NSCLC patients, with ...

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

Stereotactic ablative radiotherapy for locally advanced non ... The study included reports that assessed the outcomes of SABR treatment in patients with LA-NSCLC. Studies evaluating SBRT as a boost following primary ...

4. 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 ...

5. clinical-lung-cancer.com clinical-lung-cancer.com/article/S1525-7304(18)30237-7/abstract

Five-year Long-term Outcomes of Stereotactic Body ... A total of 186 patients (204 lesions) were analyzed. Most patients were inoperable (82%) with Eastern Cooperative Oncology Group performance status of 1 (59%) ...

6. 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.

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

Safety and Efficacy of Stereotactic Ablative Radiotherapy for ... Patients with ultra-central lung cancer can benefit from stereotactic body radiotherapy with a dose of 56/6-8f Gy. Smaller PTV was associated ...

8. jto.org jto.org/article/S1556-0864(24)00684-1/fulltext

Real-World Acute Toxicity and 90-Day Mortality in Patients ... This real-world study confirms that clinically relevant acute toxicity after lung SBRT for stage I NSCLC is rare. Data verification processes of ...

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

Stereotactic Radiation for Ultra-Central Non-Small Cell ... The goals of this study were to determine the maximum tolerated dose (MTD) of SBRT and to assess treatment-related toxicity, oncologic outcomes, ...