Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Memorial Sloan Kettering Cancer Center
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
All patients:
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
Cohort A:
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 ≥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
Cohort B:
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).
You may not be if
All patients:
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
Cohort A:
Continuous oxygen use
Metallic implant,exclusions will be determined per institutional policies
Pacemaker and defibrillators are excluded
Stents etc. will be evaluated according to MSKCC policy
Unmanageable claustrophobia
High risk for nephrogenic systemic fibrosis
Clareo Health | Stereotactic Body Radiation Therapy for Inoperable Locally-advanced Non-small Cell Lung Cancer
