Stereotactic Body Radiation Therapy Followed by Surgery in Treating Patients With Stage I-IIIA Non-small Cell Lung Cancer
Stage I Non-Small Cell Lung Cancer AJCC v7, Stage IA Non-Small Cell Lung Carcinoma AJCC v7, Stage IB Non-Small Cell Lung Carcinoma AJCC v7
About this trial
This is an interventional treatment trial for Stage I Non-Small Cell Lung Cancer AJCC v7
Eligibility Criteria
Inclusion Criteria:
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of =< 2
Have histologically proven diagnosis of: non-small cell lung cancer (NSCLC) (stage I, II, or IIIa)
- Neoadjuvant or induction chemotherapy or biological (immune, vaccine, etc.)therapy for stage IIIa is allowed
- Chemotherapy for another invasive malignancy is permitted if it has been treated definitively and the patient has remained disease free for >3 years
Participant is able to undergo surgery (planned lobectomy or wedge resection)
- Specifically, the participant has been or will have been cleared for surgery at the time of enrollment; the surgeon can accept the baseline tests done within 45 days prior to SBRT to clear the patient for surgery
- Participants of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) during treatment
- Participant or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure
Exclusion Criteria:
- Contraindication to SBRT (this includes the inability to cooperate with any aspect of SBRT: such as the inability to lie still and breathe reproducibly)
- Previous radiotherapy to the volume of lung or mediastinum currently involved by tumor
- Previous surgery for this lung or mediastinum tumor
- Plans for the patient to receive other concomitant antineoplastic therapy (including standard fractionated radiotherapy, chemotherapy, biological therapy, vaccine therapy, and surgery) while on this protocol(does not apply to neoadjuvant therapy as in inclusion criteria) except at disease progression
- Patients with active systemic, pulmonary, or pericardial infection
- Pregnant or nursing female participants
- Unwilling or unable to follow protocol requirements
- Any condition which in the investigator?s opinion deems the participant ineligible
- Received an investigational agent within 30 days prior to enrollment
- Stage IIIb
Sites / Locations
- Roswell Park Cancer Institute
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
Study 1 (highest-dose of SBRT, surgery)
Study 2 (lowest-dose of SBRT, surgery)
Study 3 (lowest- or higher-dose of SBRT, surgery)
Patients with stage I or II NSCLC in the peripheral lung undergo highest-dose of Stereotactic Body Radiation Therapy over a single treatment fraction on day 1. Patients then undergo thoracic surgery on day 28.
Patients with stage I or II NSCLC in the central lung undergo lowest-dose of Stereotactic Body Radiation Therapy over a single treatment fraction on day 1. Patients then undergo thoracic surgery on day 28.
Patients with stage IIIA NSCLC in the any lung location undergo lowest- or higher-dose of Stereotactic Body Radiation Therapy over a single treatment fraction on day 1. Patients then undergo thoracic surgery on day 28.