Surgery vs Stereotactic Body Radiation Therapy for Lung Cancer

(SORT Trial)

Recruiting at 8 trial locations

Overseen By Benjamin D Kozower, M.D., MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Washington University School of Medicine

Disqualifiers: Prior malignancies, Neuroendocrine carcinoma, Prior thoracic radiation, others

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

Compensation: Varies

Number of Visits: 1

Duration: 1-2 weeks

444 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two treatments for stage I non-small cell lung cancer (NSCLC): surgery and stereotactic body radiation therapy (SBRT), a targeted, high-dose radiation treatment. Researchers aim to assess how these treatments impact patients' health and daily lives over time. Individuals with stage I NSCLC who do not use home oxygen and are healthy enough for either treatment may be suitable candidates. The goal is to determine which treatment provides better outcomes for patients. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants an opportunity to contribute to potentially groundbreaking treatment advancements.

Do I need to stop my current medications to join the 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.

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

Research has shown that stereotactic body radiation therapy (SBRT) is generally safe for treating early-stage non-small cell lung cancer (NSCLC). In one study, only about 3.5% of patients experienced serious side effects from their cancer treatment. Another study found that over three years, 9.4% of patients experienced severe side effects, with lung inflammation being the most common, affecting four individuals.

SBRT safely delivers precise radiation doses, even to previously treated areas. While serious side effects can occur, they remain relatively uncommon. Prospective participants should discuss any concerns with a healthcare provider before joining a clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Stereotactic Body Radiation Therapy (SBRT) for Stage I Non-Small Cell Lung Cancer because it offers a non-invasive alternative to surgery, which is the current standard treatment. Unlike surgery, which involves physically removing the tumor, SBRT delivers high doses of radiation directly to the tumor with precision, minimizing damage to surrounding healthy tissue. This precision means fewer side effects and a quicker recovery time, making it a potentially appealing option for patients who may not be ideal candidates for surgery due to health concerns or personal preference.

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

Research has shown that stereotactic body radiation therapy (SBRT) is effective for early-stage lung cancer, specifically stage I non-small cell lung cancer (NSCLC). Studies have found that SBRT controls the tumor at its original site about 90% of the time, similar to the success rate of surgery. Additionally, the five-year survival rate after SBRT ranges from 43% to 83%. Compared to traditional treatments, SBRT has higher success rates, with about 80% to 90% of patients doing well after two years. These findings suggest that SBRT is a promising option for patients with early-stage NSCLC. ^{6 7 8 9 10}

Who Is on the Research Team?

Benjamin D Kozower, M.D., MPH

Principal Investigator

Washington University School of Medicine

Are You a Good Fit for This Trial?

Inclusion Criteria

FEV1 and DLCO ≥ 40% predicted

Clinical stage I NSCLC (T1 or T2a, N0, M0) by CT performed within 90 days of screening.

PET/CT is required within 90 days of screening except under circumstances where the clinical picture suggests, or biopsy confirms, a low-grade adenocarcinoma.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either surgery or stereotactic body radiation therapy (SBRT) for stage I non-small cell lung cancer

1-2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, with patient-reported outcomes collected

36 months

Visits at baseline, 1 month, 6 months, 12 months, 24 months, and 36 months post-treatment

What Are the Treatments Tested in This Trial?

Interventions

• Stereotactic Body Radiation Therapy
• Surgery

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?

Washington University School of Medicine

Lead Sponsor

Trials

2,027

Recruited

2,353,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S0167814025052144

Long-Term outcomes of ablative stereotactic body radiation ... The 1-, 2-, and 3-year OS rates were 73.9 %, 39.8 %, and 26.1 % from diagnosis, and 64.0 %, 36.0 %, and 22.1 % from SBRT, respectively. The mOS ...

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. oncodaily.com oncodaily.com/oncolibrary/radiotherapy/stereotactic-radiotherapy-success

Success Rate and Survival After Stereotactic Radiotherapy Two-year success rates for SBRT ranging from 80% to 90%, comparable to surgery, versus 30% to 40% for conventional treatment.

4. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2723641

Long-term Outcomes of Stereotactic Body Radiotherapy for ... This cohort study of pooled individual patient data assesses long-term outcomes after stereotactic body radiotherapy for low-risk and ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4941022/

Clinical outcomes and prognostic factors of cyberknife ... In-field recurrence free rate at 2-years was 81.6 %, tumor response rate (CR + PR) was 88 %, and 1- and 2-year overall survival rates were 63.5 ...

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

Safety and Efficacy of Stereotactic Ablative Radiotherapy for ... After receiving SBRT, only 2 (3.5%) patients experienced grade ≥3 cancer-related toxicities. One patient with dyspnea had grade 5 radiation ...

7. redjournal.org redjournal.org/article/S0360-3016(24)00508-X/fulltext

Safety and Efficacy of Stereotactic Body Radiation Therapy ... The incidence of severe toxicity was 9.4% at 3 years. The most common severe toxicity was pneumonitis (n = 4). There was 1 possible treatment- ...

8. jamanetwork.com jamanetwork.com/journals/jamaoncology/fullarticle/2778658

Evaluation of Safety of Stereotactic Body Radiotherapy for ... Standard doses were safe in all 35 evaluable patients, with a median of 3 metastases; there were no protocol-defined dose-limiting toxicities, ...

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

Safety and Efficacy of Stereotactic Body Radiation Therapy ... The incidence of severe toxicity was 9.4% at 3 years. The most common severe toxicity was pneumonitis (n = 4). There was 1 possible treatment-related death from ...

10. cancer.stonybrookmedicine.edu cancer.stonybrookmedicine.edu/diagnosis-treatment/radiation-oncology/treatment-technology/sbrt

SBRT: Stereotactic Body Radiation Therapy SBRT can deliver an optimal radiation dose to both new primary and metastatic cancer sites. It can also be used on previously irradiated sites safely to avoid ...