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RPCI 1509   |   CC760
A Phase II Randomized Study of 2 Stereotactic Body Radiation Therapy (SBRT) Regimens for Medically Inoperable Patients with Node Negative, Peripheral Non - Small Cell Lung Cancer

Main Campus
Phase 2

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  1. To compare incidence of toxicity with two established SBRT regimens for NSCLC
  2. To compare QOL, patterns of failure, disease free survival, and overall survival associated with 2 two established SBRT regimens for NSCLC
  3. To correlate outcomes and toxicities with imaging and patient and tumor biomarkers

Inclusion Criteria
  1. Histologically confirmed NSCLC
  2. T1 - T2, NO measuring ≤ 5 em (T3 based on chest wall involvement is excluded)
  3. Surgically resectable primary, however patient evaluated by thoracic surgeon and deemed medically inoperable or patient refuses surgical resection
  4. Age ≥ 18

Exclusion Criteria
  1. Prior Thoracic Radiation Therapy
  2. T2 or T3 tumor greater than 5 em or T3 tumor based on chest wall involvement
  3. Node positive or metastatic disease
  4. Tumor location within the zone of the proximal bronchial tree. The proximal bronchial tree is defined as the carina, right and left main bronchi, right and left upper lobe bronchi, bronchus intermedius, right middle lobe bronchus, lingular bronchus, and right and left lower lobe bronchi. The zone of the proximal bronchial tree is defined as a volume 2cm in all directions around the proximal bronchial tree.
  5. Other conditions deemed by the PI or associates to make the patient ineligible for protocol investigations, procedures, and high-dose external beam radiotherapy. This includes the inability to cooperate with any aspect of SBRT such as the inability to lie still and breathe reproducibly.
  6. Pregnant or unwilling to use adequate contraception.

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