For Healthcare Professionals

Veterans Affairs Lung Cancer Surgery Or Stereotactic Radiotherapy

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About the study

Patients with stage I non-small cell lung cancer have been historically treated with surgery whenever they are fit for an operation. However, an alternative treatment known as stereotactic radiotherapy now appears to offer an equally effective alternative. Doctors believe both are good treatments and are therefore conducting this study to determine if one may be possibly better than the other.
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

Inclusion Criteria:


Inclusion Criteria for Screening


  1. Age 18 or older
  2. Any patient with a preliminary diagnosis of stage I Non-Small Cell Lung Cancer (NSCLC), whether pathologically proven by biopsy, or highly suspicious by radiographic imaging. [Participants will ultimately need biopsy confirmation before enrolling]
  3. Primary tumor size less than or equal to 5 cm by CT (may include CT images from PET/CT)
  4. Karnofsky performance status greater than or equal to 70
  5. Participant has willingness and ability to provided informed consent for participation

Inclusion Criteria for Randomization


  1. Biopsy proven non-small cell lung cancer
  2. Participant's case reviewed at multidisciplinary conference
  3. Tumor size less than or equal to 5cm (measured on the most recent CT images available, and may include PET/CT images)
  4. Tumor is equal to or greater than 1.0cm from the trachea, esophagus, brachial plexus, 1st bifurcation of the proximal bronchial tree, or spinal cord (measured on the most recent CT images available, and may include PET/CT images).
  5. Mandatory FDG-PET/CT within 60 days of the randomization date (note: FDG-PET/CT may need to be repeated prior to treatment if outside of this requirement)
  6. Mandatory pathological assessment of any lymph nodes >10mm with a SUV >2.5 seen on FDG- PET/CT
  7. Mandatory biopsy of any additional concerning lesions seen on FDG-PET/CT, to make better determination that the patient is not harboring metastatic disease or a secondary primary malignancy.
  8. Pre-operative FEV1 greater than or equal to 40% of predicted value and pre-operative DLCO greater than or equal to 40% of predicted value.
  9. Formally evaluated and documented by a local thoracic surgeon to be medically fit to undergo a complete anatomic pulmonary resection (wedge resection not allowed)
  10. Formally evaluated and documented by a local radiation oncologist to be eligible to receive protocol-defined stereotactic radiotherapy
  11. Participant willingness to be randomized

EXCLUSION CRITERIA

Exclusion Criteria:


Exclusion Criteria for Screening


  1. Previously evaluated by a local thoracic surgeon and determined to be medically inoperable
  2. Pathological confirmation of nodal or distant metastasis
  3. Prior history of lung cancer, not including current lesion
  4. Prior history of thoracic surgery or lung or esophageal cancer. [prior cardiac surgery acceptable]
  5. Prior history of radiotherapy to the thorax
  6. Prior history of invasive state I-III malignancy treated with surgery, radiation therapy, chemotherapy, immunotherapy, or targeted therapy in the past 2 years, excluding prostate cancer, low-risk papillary thyroid cancer (less than or equal to 1 cm), follicular lymphoma, or chronic lymphocytic leukemia.
  7. Prior history of IV malignancy, excluding follicular lymphoma, chronic lymphocytic leukemia, or hormone sensitive prostate cancer confined to the pelvis.
  8. Ever diagnosed with stage IV metastatic cancer of any type
  9. History of scleroderma
  10. Positive Pregnancy test (for women <61 years of age or without prior hysterectomy)

Exclusion Criteria for Randomization


Pathological confirmation of nodal or metastatic disease


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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.

Study’s details


Contition

Lung Neoplasm

Age (in years)

18+

Phase

Not Applicable

Participants needed

670

Est. Completion Date

Sep 30, 2027

Treatment type

Interventional


Sponsor

VA Office of Research and Development

ClinicalTrials.gov identifier

NCT02984761

Study number

2005

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