Surgery vs Stereotactic Ablative Radiotherapy for Lung Cancer

(STABLE-MATES Trial)

Recruiting at 26 trial locations

Overseen By Sarah Neufeld, MBA

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: University of Texas Southwestern Medical Center

Disqualifiers: Distant metastases, Prior radiation, Pregnancy, others

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 6-8 weeks

272 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a special type of targeted radiation therapy, called Stereotactic Ablative Radiotherapy (SAbR), can help people with early-stage lung cancer live longer than traditional lung surgery. It focuses on patients with operable Stage I non-small cell lung cancer (NSCLC) who are considered high risk for surgery. Patients with operable non-small cell lung cancer who might struggle with major surgeries could be suitable candidates. As a Phase 3 trial, this study represents the final step before FDA approval, offering patients a chance to access potentially life-extending treatment.

Will I have to stop taking my current medications?

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.

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

Research has shown that Stereotactic Ablative Radiotherapy (SAbR) is generally easy for patients to handle. Studies have found that SAbR can effectively treat tumors with a low risk of serious side effects. Even patients with high-risk tumors have experienced few severe side effects, indicating that while some side effects might occur, they are usually not serious.

Lung surgery is well-known for its safety due to its common use as a treatment. Most patients handle the surgery well, though risks such as infection or issues with anesthesia can occur, as with any surgery.

Overall, both SAbR and lung surgery have demonstrated safety in treating lung cancer. However, individual experiences with medical treatments can vary. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard of care for early-stage lung cancer, which typically involves invasive surgery to remove the tumor, Stereotactic Ablative Radiotherapy (SAbR) offers a non-invasive alternative. SAbR uses highly focused radiation beams that precisely target the cancer cells, minimizing damage to surrounding healthy tissue. Researchers are excited about SAbR because it can be delivered in just a few sessions, potentially offering quicker recovery times and fewer complications compared to traditional surgery. Additionally, for patients who may not be good surgical candidates due to other health issues, SAbR provides a promising treatment option.

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

This trial will compare Lung Surgery with Stereotactic Ablative Radiotherapy (SAbR) for treating lung cancer. Research has shown that SAbR, a type of focused radiation treatment, can lead to positive outcomes for lung cancer patients. A review of several studies found that SAbR effectively controls tumors and helps patients live longer, with few side effects. One study noted that when SAbR was combined with chemotherapy, survival rates reached 80.5% at three years and 46% at five years, though these results were not statistically significant. SAbR is particularly effective for small tumors, providing strong control with minimal side effects. These findings suggest that SAbR could be a promising treatment option for lung cancer, offering benefits in both effectiveness and safety. ^{1 4 6 7 8}

Who Is on the Research Team?

Robert Timmerman, MD

Principal Investigator

UTSW Medical Center

Are You a Good Fit for This Trial?

This trial is for adults over 18 with high-risk operable Stage I non-small cell lung cancer (NSCLC) that can be removed by surgery. Candidates must have a tumor ≤ 4 cm, located peripherally in the lung, and no distant metastases. They should not have had previous thoracic radiation therapy or treatment for this lung cancer and must not be pregnant.

Inclusion Criteria

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

Ability to understand and the willingness to sign a written informed consent

My lung cancer has not spread to certain lymph nodes, confirmed by a biopsy.

Exclusion Criteria

pregnant and lactating women

My cancer has spread to distant parts of my body.

I have had radiation therapy not aimed at my lungs and no lung surgery on the affected side.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-randomization

Patients are pre-randomized to either SR or SAbR and informed consent is obtained

1-2 weeks

Treatment

Participants receive either Sublobar Resection (SR) or Stereotactic Ablative Radiotherapy (SAbR)

6-8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 years

Long-term follow-up

Participants are monitored for progression-free survival and overall survival

5 years

What Are the Treatments Tested in This Trial?

Interventions

• Lung Surgery
• SAbR

Trial Overview The study aims to compare survival outcomes between two treatments: sublobar resection (SR), which is a type of lung surgery, and stereotactic ablative radiotherapy (SAbR). It's designed to see if SAbR offers better survival rates than SR in patients with early-stage NSCLC who are at high risk from traditional surgery.

How Is the Trial Designed?

Group I: Arm 2 radiation therapy Experimental Treatment 1 Intervention

Stereotactic Ablative Radiotherapy (SAbR)

Group II: Arm 1 lung surgery Active Control 1 Intervention

Sublobar Resection (SR)

Lung Surgery is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

Approved in European Union as Lung Surgery for:

• Lung cancer
• Infections
• Trauma
• Lung transplants
• Tuberculosis
• Lung abscess
• Emphysema
• Benign tumors
• Fungal infections

Approved in United States as Lung Surgery for:

• Lung cancer
• Infections
• Trauma
• Lung transplants
• Tuberculosis
• Lung abscess
• Emphysema
• Benign tumors
• Fungal infections

Approved in Canada as Lung Surgery for:

• Lung cancer
• Infections
• Trauma
• Lung transplants
• Tuberculosis
• Lung abscess
• Emphysema
• Benign tumors
• Fungal infections

Approved in Japan as Lung Surgery for:

• Lung cancer
• Infections
• Trauma
• Lung transplants
• Tuberculosis
• Lung abscess
• Emphysema
• Benign tumors
• Fungal infections

Approved in China as Lung Surgery for:

• Lung cancer
• Infections
• Trauma
• Lung transplants
• Tuberculosis
• Lung abscess
• Emphysema
• Benign tumors
• Fungal infections

Approved in Switzerland as Lung Surgery for:

• Lung cancer
• Infections
• Trauma
• Lung transplants
• Tuberculosis
• Lung abscess
• Emphysema
• Benign tumors
• Fungal infections

Who Is Running the Clinical Trial?

University of Texas Southwestern Medical Center

Lead Sponsor

Trials

1,102

Recruited

1,077,000+

Published Research Related to This Trial

Stereotactic body radiation therapy (SBRT) is emerging as a significant alternative to surgery for treating early-stage non-small cell lung cancer, demonstrating its potential effectiveness.

The study presents two cases where SBRT was used, and subsequent imaging and biopsies were conducted to monitor for recurrence, highlighting the importance of follow-up in assessing treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Illustrative cases of false positive biopsies after stereotactic body radiation therapy for lung cancer based on abnormal FDG-PET-CT imaging. Singhvi, M., Lee, P.[2023]

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 2373 patients with stage I non-small cell lung cancer, those who underwent lobectomy had better survival rates compared to those treated with stereotactic ablative radiotherapy (SABR) at both 1 and 2 years post-treatment.

Patients receiving SABR experienced significant delays in treatment (median of 73 days) compared to those undergoing surgery (median of 17 days), which may contribute to the poorer long-term outcomes associated with SABR.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Post-treatment survival difference between lobectomy and stereotactic ablative radiotherapy in stage I non-small cell lung cancer in England. Khakwani, A., Harden, S., Beckett, P., et al.[2022]

In a study of 84 patients with early-stage lung cancer treated with stereotactic body radiation therapy (SBRT), the incidence of radiation pneumonitis (RP) was low and similar between patients with and without previous lung surgery, indicating that SBRT is safe for those who have undergone anatomic lung resection.

While there was a trend towards increased pulmonary toxicity in patients with prior lung surgery, the overall rates of toxicity were low, and SBRT demonstrated comparable local control and survival outcomes for both groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk of Pneumonitis After Stereotactic Body Radiation Therapy in Patients With Previous Anatomic Lung Resection. Hayes, JT., David, EA., Qi, L., et al.[2018]

A meta-analysis of 15 studies involving 7,810 patients with T1-3N0M0 non-small cell lung cancer (NSCLC) found that patients treated with SBRT/SABR had significantly worse 5-year survival rates compared to those who underwent surgery, indicating that surgery may be a more effective treatment option.

The study also revealed that SBRT/SABR resulted in lower recurrence-free survival rates, suggesting that surgical interventions like lobectomy or sublobectomy are preferable for better long-term outcomes in NSCLC patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic body radiotherapy or stereotactic ablative radiotherapy versus surgery for patients with T1-3N0M0 non-small cell lung cancer: a systematic review and meta-analysis. Li, M., Yang, X., Chen, Y., et al.[2022]

In a study of 382 patients with clinical stage I non-small cell lung cancer, the 3-year overall survival rate was significantly higher for those who underwent sublobar resection (86.6%) compared to those who received stereotactic body radiotherapy (57%).

However, after adjusting for various factors like age and pulmonary function, the type of treatment (SLR vs. SBRT) did not significantly impact survival outcomes, suggesting that SBRT may be a viable treatment option for selected high-risk patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sublobar Resection versus Stereotactic Body Radiation Therapy for Clinical Stage I Non-Small Cell Lung Cancer: A Study Using Data from the Korean Nationwide Lung Cancer Registry. Yun, J., Cho, JH., Hong, TH., et al.[2023]

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]

A meta-analysis of eight studies found that while stereotactic ablative radiotherapy (SABR) and lobectomy showed similar one-year overall survival (OS) and cause-specific survival (CSS), lobectomy significantly improved three-year and five-year OS and CSS for patients with early-stage non-small cell lung cancer (NSCLC).

Lobectomy also demonstrated better recurrence-free survival (RFS) at three years compared to SABR, indicating that surgical intervention may offer more favorable long-term outcomes for these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic ablative radiotherapy versus lobectomy for stage I non-small cell lung cancer: A systematic review. Wang, S., Wang, X., Zhou, Q., et al.[2018]

In a study comparing video-assisted thoracoscopic surgery (VATS) lobectomy and stereotactic body radiotherapy (SBRT) for stage I non-small cell lung cancer (NSCLC), VATS lobectomy showed significantly better long-term outcomes, including overall survival (68.5% vs. 37.3% at 5 years) and recurrence-free survival (60.4% vs. 19.5% at 5 years).

The study involved 413 patients undergoing VATS lobectomy and 104 patients receiving SBRT, with a follow-up period of up to 120 months, indicating that VATS lobectomy may be a more effective treatment option for operable patients with early-stage NSCLC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Video-assisted thoracoscopic lobectomy versus stereotactic radiotherapy for stage I lung cancer. Hamaji, M., Chen, F., Matsuo, Y., et al.[2022]

In a study of 102 patients treated with stereotactic ablative radiation therapy (SABR) for early-stage non-small-cell lung cancer, a significant correlation was found between higher Biological Equivalent Doses (BED) over 300 Gy and the development of radiological changes such as organizing pneumonia and lung affectation over a 2-year follow-up.

Radiological changes were more pronounced in patients receiving BEDs greater than 300 Gy to healthy lung volumes of at least 30 cc, suggesting that these findings could inform future radiotherapy dose constraints to minimize pulmonary toxicity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biological equivalent dose is associated with radiological toxicity after lung stereotactic ablative radiation therapy. Cases, C., Benegas, M., Sánchez, 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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A systematic review of outcomes following stereotactic ... Although not statistically significant, the 3- and 5- year survival rates for the patients who received SABR plus adjuvant chemotherapy were 80.5% and 46%, ...

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

A prospective outcomes and cost-effective analysis of surgery ... To evaluate long-term outcomes, treatment costs, and quality of life associated with curative treatment of newly diagnosed stage I non-small ...

4. jto.org jto.org/article/S1556-0864(24)00763-9/fulltext

Historical Versus Modern Data of Stereotactic Ablative ... The results support the utilization of SABR for these patients (with a 90-day toxicity rate of 3.8% and a 90-day all-cause mortality of 1.7%), but more ...

5. jamanetwork.com jamanetwork.com/journals/jamaoncology/fullarticle/2809582

Individualized Stereotactic Ablative Radiotherapy for Lung ... Retrospective data suggested that small tumors up to 10 cm3 in volume can be well controlled with a biologically effective dose less than 100 Gy ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39674443/

Systematic Review of Stereotactic Ablative Radiotherapy ... Medical inoperability (93-95%) was the primary reason for utilizing SABR. The median rate of histologically confirmed cancer in treated patients ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0360301623003255

Safety and Efficacy Results From iSABR, a Phase 1 Study ... We are the first to report prospective data to support an acceptable per protocol toxicity profile with combination lung SABR and durvalumab in medically ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S1556086415317287

Outcomes of Stereotactic Ablative Radiotherapy for ... Our main conclusion is that SABR can achieve cures in patients with central, high-risk tumors with a low incidence of high-grade toxicity. TABLE 4. Published ...