Stereotactic Body Radiation Therapy for Inoperable Locally-advanced Non-small Cell Lung Cancer



Status:Recruiting
Conditions:Lung Cancer, Lung Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:3/15/2019
Start Date:July 5, 2013
End Date:July 2019
Contact:Andreas Rimner, MD
Phone:212-639-6025

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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.


Inclusion Criteria:

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 ≥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

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).

Exclusion Criteria:

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

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

- Unmanageable claustrophobia

- High risk for nephrogenic systemic fibrosis
We found this trial at
8
sites
225 Summit Avenue
Montvale, New Jersey 07645
Phone: 212-639-6025
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136 Mountainview Blvd
Basking Ridge, New Jersey 7920
(908) 542-3000
Phone: 212-639-6025
Memorial Sloan-Kettering Cancer Center - Basking Ridge At Memorial Sloan Kettering Basking Ridge, we offer...
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Commack, New York 11725
Phone: 212-639-6025
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500 Westchester Avenue
Harrison, New York 10604
Phone: 212-639-6025
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Middletown, New Jersey 07748
Phone: 212-639-6025
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1275 York Ave
New York, New York 10021
(212) 639-2000
Principal Investigator: Andreas Rimner, MD
Phone: 212-639-6025
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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New York, NY
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1000 N Village Ave
Rockville Centre, New York 11570
(516) 256-3600
Principal Investigator: Andreas Rimner, MD
Phone: 212-639-6025
Memorial Sloan-Kettering at Mercy Medical Center Memorial Sloan Kettering Cancer Center Rockville Centre provides state-of-the-art...
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Uniondale, New York 11553
Phone: 212-639-6025
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Uniondale, NY
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