Lung Cancer Clinical Trial
Stereotactic Body Radiation Therapy for Inoperable Locally-advanced Non-small Cell Lung Cancer
The purpose of this study is to determine if the use of exploratory immunologic biomarkers, functional MRI images can serve as early predictors for response of NSCLC. It also will provide important information on the perceived side effects from a patient perspective. Patients may participate if they have tumors ≥3 cm without lymph node involvement (for which chemotherapy is not part of the standard of care). Patients will only receive stereotactic body radiation therapy (SBRT) per standard dose guidelines.
Histologically confirmed non-small cell lung cancer
Medically or technically inoperable as per thoracic surgeon or patient's preference not to undergo surgical resection
Age ≥ 18 years
Women of childbearing potential must have a negative blood pregnancy test
Ability to provide written informed consent
Stage IIA-IIIA (TanyN1M0 or T2b-4N0M0) Selected patients with single station N2 nodal involvement in close proximity to the primary tumor target may be considered eligible at the discretion of the PI if all normal tissue guidelines can be met
Eligible for chemo-therapy
Karnofsky Performance Status ≥70%
Men and women of childbearing potential must be willing to use effective contraception while on treatment and for at least 3 months thereafter
Patients must show adequate organ function as defined by:
Calculated creatinine clearance ≥40 mL/min for patients receiving pemetrexed (by Cockcroft-Gault)
Calculated creatinine clearance ≥30 mL/min for patients receiving gemcitabine or paclitaxel (by Cockcroft-Gault) Total bilirubin less than 1.5 x ULN (unless known Gilbert's disease)
AST and ALT less than 3 x ULN
Absolute neutrophil count greater than 1500/mm3
Platelet count greater than 100,000/mm3
T2a-4N0M0 who are not candidates for cohort A or who will not be treated with chemotherapy (due to patient preference or at the recommendation of the treating physician).
Prior radiation therapy to the lungs
Prior surgery or chemotherapy for this presentation of lung cancer (history of prior lung cancer that has been treated and deemed inactive by the clinician is acceptable. Recurrent tumors may be treated on protocol as long as SBRT will be the definitive treatment.)
N2-3 lymph node involvement based on PET/EBUS-FNA/mediastinoscopy (Any N2 disease that is more than just minimal single station involvement is excluded)
Direct tumor extension into including aorta or pulmonary artery
Chronic corticosteroid use equivalent to ≥ prednisone 10 mg daily
Prior treatment with a CD137 agonist, ipilimumab, or the CTLA-4 inhibitor, or PD-1/PDL-1 inhibitor
Unstable congestive heart failure
Continuous oxygen use
Patients meeting the following exclusion criteria will be excluded from the functional MRI portion only:
Metallic implant,exclusions will be determined per institutional policies
Pacemaker and defibrillators are excluded
Stents etc. will be evaluated according to MSKCC policy
High risk for nephrogenic systemic fibrosis
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There are 7 Locations for this study
Basking Ridge New Jersey, 07920, United States
Middletown New Jersey, 07748, United States
Montvale New Jersey, 07645, United States
Commack New York, 11725, United States
Harrison New York, 10604, United States
New York New York, 10065, United States
Rockville Centre New York, , United States
Uniondale New York, 11553, United States
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