Comparing the Effectiveness of Surgery Versus Stereotactic Body Radiation Therapy for Stage I Non-Small Cell Lung Cancer (SORT)

Plain English Summary

Surgery Versus Stereotactic Body Radiation Therapy for Stage I Non-Small Cell Lung Cancer is a Not Applicable clinical trial sponsored by Washington University School of Medicine studying Non Small Cell Lung Cancer, Non-small Cell Lung Cancer. This study compares the effectiveness of surgery versus a type of radiation therapy called Stereotactic Body Radiation Therapy (SBRT) for early-stage non-small cell lung cancer. It is for patients diagnosed with Stage I non-small cell lung cancer. Participation involves patients being screened and then having their treatment plan determined before being enrolled. Patient-reported outcomes and survival data will be collected for up to 3 years. The main alternative treatment is the other option being studied (surgery if radiation is considered, or vice versa). The trial aims to enroll 446 participants.

Official Summary

The development of stereotactic body radiation therapy (SBRT) for the treatment of stage I non-small cell lung cancer (NSCLC) has inspired a close partnership between thoracic surgery and radiation oncology. In this study, patients with stage I NSCLC will be screened prior to treatment and will be consented after their treatment plan has been determined. Prospectively collected patient-reported outcomes (PROs) will be collected for 3 years or for the duration of the study (whichever is shorter), as will outcomes data.

Who Can Participate

Here is what you need to know about eligibility for this trial. Patients with Stage I non-small cell lung cancer (based on CT scans and potentially PET scans). Individuals must be at least 18 years old and healthy enough for either surgery or SBRT. Patients cannot have had prior treatment for this specific lung cancer, or other certain types of cancer, or prior radiation to the chest that would overlap. Tumors that are very close to major airways or blood vessels, or require removal of an entire lung, may not be eligible. This trial is studying Non Small Cell Lung Cancer, Non-small Cell Lung Cancer, so participants generally need a confirmed diagnosis.

What They're Measuring

Disease-free survival means how long patients live without their cancer returning, and the PROMIS survey measures how patients feel about their health and quality of life over time. The specific primary outcome measures are: Disease-free survival (DFS) (Through 36 months post-treatment (estimated to be 36 months and 1 week)); Change in patient-reported outcomes as measured by the PROMIS Bank survey (From baseline through 36 months post-treatment (estimated to be 36 months and 1 week)). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.

Why This Trial Matters

This trial matters because it aims to determine the best treatment approach between surgery and SBRT for early-stage lung cancer, addressing a gap in understanding which option leads to better long-te This research targets Non Small Cell Lung Cancer, Non-small Cell Lung Cancer, where improved treatment options are needed.

Investor Insight

This observational study provides valuable data for treatment decisions in a common cancer type, potentially influencing clinical guidelines and future research, which is significant for the oncology

Is This Trial Right for Me?

Ask your doctor if you are eligible for both surgery and SBRT, and what the specific risks and benefits of each are for your situation. Understand that your treatment will be decided by your doctors and you, and then you will be followed for up to 3 years to track your health and cancer status. Be prepared to answer surveys about your health and well-being periodically for up to 3 years. The trial is being conducted at 8 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

• Study Type: OBSERVATIONAL
• Enrollment: 446 participants

Primary Outcomes

• Disease-free survival (DFS) (Through 36 months post-treatment (estimated to be 36 months and 1 week))
• Change in patient-reported outcomes as measured by the PROMIS Bank survey (From baseline through 36 months post-treatment (estimated to be 36 months and 1 week))

Secondary Outcomes

• Cancer-specific survival (CSS) (Through 36 months post-treatment (estimated to be 36 months and 1 week))
• Overall survival (OS) (Through 36 months post-treatment (estimated to be 36 months and 1 week))
• Treated-related mortality (At 30 days (estimated to be 1 month and 1 week))
• Number of post-treatment events (grade 3 and above) (Through 36 months post-treatment (estimated to be 36 months and 1 week))

Full Eligibility Criteria

Inclusion Criteria:

* 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.
  * Biopsy is strongly encouraged. In the event biopsy is not performed, rationale must be provided for performing empiric treatment.
  * Patients with hilar or mediastinal lymph nodes ≤ 1 cm and no abnormal hilar or mediastinal uptake on PET will be considered N0. Pre-treatment mediastinal lymph node sampling by any technique is allowed but not required. Patients with \> 1 cm hilar or mediastinal lymph nodes on CT or abnormal PET (including suspicious but nondiagnostic uptake) are be eligible only if directed tissue biopsies of all abnormally identified areas are negative for cancer.
* First primary NSCLC on the ipsilateral side.
* At least 18 years of age.
* Clinically eligible for either treatment (surgical resection or SBRT). Because this is a pragmatic study and treatment decisions are at the discretion of the treating physicians and their patients, patients must be eligible for either treatment. To be considered eligible for either treatment, patients must have:

  * ECOG performance status ≤ 2
  * No home oxygen use
  * FEV1 and DLCO ≥ 40% predicted
  * No symptomatic congestive heart failure as documented by NYHA I-II functional classification
  * Been deemed operable by a thoracic surgeon, per clinical visit or review of the medical record and as documented by e-mail, tumor board, study meetings, or other acceptable source documentation. In addition to operability, the surgeon must define what anticipated surgical approach and procedure would be undertaken.
  * Been deemed treatable by a radiation oncologist with 10 or fewer fractions of SBRT, per clinical visit or review of the medical record and as documented by e-mail, tumor board, study meetings, or other acceptable source documentation. In addition to suitability for SBRT, the radiation oncologist must define which dose and fractionation would be undertaken.
* Ability to understand and willingness to sign an IRB-approved written informed consent document.
* Agrees to receive treatment for clinical stage I NSCLC (either surgical resection or SBRT).

Exclusion Criteria:

* Prior or concurrent malignancies, unless the natural history of the prior or concurrent malignancy does not have the potential to interfere with the interpretation of the results of the study.
* Clinically diagnosed or biopsy proven low-grade neuroendocrine carcinoma (carcinoid).
* Prior thoracic radiation therapy that would overlap with the lung cancer being treated on study.
* Previous chemotherapy, radiotherapy, or surgical resection specifically for the lung cancer being treated on study.
* Prior lung resection on the ipsilateral side positive for malignancy.
* Patients with central tumors requiring a sleeve lobectomy or pneumonectomy.
* "Ultra-central" lesions (defined as a lesion that directly contacts or overlaps the trachea, main bronchus, esophagus, or pulmonary vessels).
* Concurrent enrollment in a therapeutic trial for the index cancer.
* Synchronous primary lung cancer.
* Uncontrolled or symptomatic psychiatric condition.

Trial Locations

• Emory University, Atlanta, Georgia, United States
• Carle Cancer Institute, Urbana, Illinois, United States
• Washington University School of Medicine, St Louis, Missouri, United States
• Memorial Sloan Kettering, New York, New York, United States
• Duke University, Durham, North Carolina, United States
• Cleveland Clinic, Cleveland, Ohio, United States
• University of Texas MD Anderson Cancer Center, Houston, Texas, United States
• University of Toronto, Toronto, Ontario, Canada

Frequently Asked Questions

Related Conditions

• Non-Small Cell Lung Cancer
• Lung Cancer
• Thoracic Oncology
• Cancer Treatment
• Radiation Oncology
• Surgical Oncology
• Early Stage Cancer
• Carcinomas
• Adenocarcinoma
• Malignant Neoplasms of the Respiratory and Digestive Systems

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