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New treatment option for Lung Neoplasm
Official title Veterans Affairs Lung Cancer Surgery Or Stereotactic Radiotherapy
ClinicalTrials.gov ID: NCT02984761
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- for Screening
- Age 18 or older
- Any patient with a preliminary diagnosis of stage I Non-Small Cell Lung Cancer (NSCLC), whether pathologically proven by biopsy, or highly suspicious...
- Primary tumor size less than or equal to 5 cm by CT (may include CT images from PET/CT)
- Karnofsky performance status greater than or equal to 70
You likely can't join if
- Exclusion Criteria for Screening
- Previously evaluated by a local thoracic surgeon and determined to be medically inoperable
- Pathological confirmation of nodal or distant metastasis
- Prior history of lung cancer, not including current lesion
- Prior history of thoracic surgery or lung or esophageal cancer. [prior cardiac surgery acceptable]
- Prior history of radiotherapy to the thorax
See the full eligibility criteria
- for Screening
- Age 18 or older
- 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...
- Primary tumor size less than or equal to 5 cm by CT (may include CT images from PET/CT)
- Karnofsky performance status greater than or equal to 70
- Participant has willingness and ability to provided informed consent for participation for Randomization
- Biopsy proven non-small cell lung cancer
- Participant's case reviewed at multidisciplinary conference
- Tumor size less than or equal to 5cm (measured on the most recent CT images available, and may include PET/CT images)
- 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...
- 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)
- Mandatory pathological assessment of any lymph nodes \>10mm with a SUV \>2.5 seen on FDG- PET/CT
- 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.
- 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.
- Formally evaluated and documented by a local thoracic surgeon to be medically fit to undergo a complete anatomic pulmonary resection (wedge resection not allowed)
- Formally evaluated and documented by a local radiation oncologist to be eligible to receive protocol-defined stereotactic radiotherapy
- Participant willingness to be assigned by chance
- Exclusion Criteria for Screening
- Previously evaluated by a local thoracic surgeon and determined to be medically inoperable
- Pathological confirmation of nodal or distant metastasis
- Prior history of lung cancer, not including current lesion
- Prior history of thoracic surgery or lung or esophageal cancer. [prior cardiac surgery acceptable]
- Prior history of radiotherapy to the thorax
- 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...
- Prior history of IV malignancy, excluding follicular lymphoma, chronic lymphocytic leukemia, or hormone sensitive prostate cancer confined to the pelvis.
- Ever diagnosed with stage IV metastatic cancer of any type
- History of scleroderma
- Positive Pregnancy test (for women \<61 years of age or without prior hysterectomy) Exclusion Criteria for Randomization
- Pathological confirmation of nodal or metastatic disease
The study team makes the final eligibility decision.
Where it's taking place
- Long Beach, California, United States
- West Los Angeles, California, United States
- Bay Pines, Florida, United States
- Miami, Florida, United States
- Hines, Illinois, United States
- Indianapolis, Indiana, United States
- Baltimore, Maryland, United States
- Boston, Massachusetts, United States
- Ann Arbor, Michigan, United States
- Minneapolis, Minnesota, United States
- Durham, North Carolina, United States
- Cleveland, Ohio, United States
- Philadelphia, Pennsylvania, United States
- Pittsburgh, Pennsylvania, United States
- Houston, Texas, United States
- Richmond, Virginia, United States
- Milwaukee, Wisconsin, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Long Beach, California, United States; West Los Angeles, California, United States; Bay Pines, Florida, United States; Miami, Florida, United States; Hines, Illinois, United States; Indianapolis, Indiana, United States and 11 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.