Phase II Evaluation with Safety Run-In of Stereotactic Ablative Body Radiation for T1-2A N1 Lung Cancer
T
Tim Lautenschlaeger, MD
Primary Investigator
Overview
The safety and efficacy of stereotactic ablative radiotherapy (SABR) in treating hilar nodes or N1 disease currently is not known fully and will be evaluated in this study.
Description
The purpose of this study is to determine if sterotactic ablative radiation therapy (SABR) followed by chemotherapy is an efficacious treatment for T1-2a N1 lunch cancer and if it is associated with an increased local control rate to at least 80% at 2 years.
Eligibility
You may be eligible for this study if you meet the following criteria:
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Conditions:
lung cancer
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Age: Between 18 Years - 100 Years
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Gender: All
Inclusion Criteria
Pathological diagnosis of NSCLC lung cancer
Staging PET/CT within 45 days of consult
EBUS or other histologic confirmation of N1 involvement (diagnosis of lung cancer should come from the hilar [N1] disease)
Baseline labs including CBC/differential and BMP within 45 days of consult
Adequate bone marrow
Adequate renal function
Adequate hepatic function
Women of childbearing potential and male participants must practice adequate contraception throughout the study
Patients with post-obstructive pneumonia are eligible provided they no longer require intravenous antibiotics at registration
Eligible for adjuvant chemotherapy as determined by the treating medical oncologist
Exclusion Criteria
Previous radiation therapy overlapping with current radiation target as determined by the discretion of the investigator
Inability to comply with treatment per investigator discretion.
Inability to follow standard of care follow up recommendations per investigator discretion.
Pregnant and breastfeeding women
Contra-indication to platinum-based two drug chemotherapy as determined by the treating medical oncologist
Patients with a history of chronic kidney disease or lactic acidosis
Severe, active co-morbidity, defined as follows:
i. Uncontrolled neuropathy ? grade 2 regardless of cause
ii. Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months
iii. Transmural myocardial infarction within the last 6 months
iv. Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
v. Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days of registration
vi. Severe hepatic disease, defined as a diagnosis of Child-Pugh Class B or C hepatic disease
vii. HIV positive with CD4 count 200 cells/microliter. Note that patients who are HIV positive are eligible, provided they are under treatment with highly active antiretroviral therapy (HAART) and have a CD4 count ? 200 cells/microliter within 30 days prior to registration. Note also that HIV testing is not required for eligibility for this protocol.
viii. End-stage renal disease (i.e. on dialysis or dialysis has been recommended).
Additional Information:Pathological diagnosis of NSCLC lung cancer
Staging PET/CT within 45 days of consult
EBUS or other histologic confirmation of N1 involvement (diagnosis of lung cancer should come from the hilar [N1] disease)
Baseline labs including CBC/differential and BMP within 45 days of consult
Adequate bone marrow
Adequate renal function
Adequate hepatic function
Women of childbearing potential and male participants must practice adequate contraception throughout the study
Patients with post-obstructive pneumonia are eligible provided they no longer require intravenous antibiotics at registration
Eligible for adjuvant chemotherapy as determined by the treating medical oncologist
Exclusion Criteria
Previous radiation therapy overlapping with current radiation target as determined by the discretion of the investigator
Inability to comply with treatment per investigator discretion.
Inability to follow standard of care follow up recommendations per investigator discretion.
Pregnant and breastfeeding women
Contra-indication to platinum-based two drug chemotherapy as determined by the treating medical oncologist
Patients with a history of chronic kidney disease or lactic acidosis
Severe, active co-morbidity, defined as follows:
i. Uncontrolled neuropathy ? grade 2 regardless of cause
ii. Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months
iii. Transmural myocardial infarction within the last 6 months
iv. Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
v. Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days of registration
vi. Severe hepatic disease, defined as a diagnosis of Child-Pugh Class B or C hepatic disease
vii. HIV positive with CD4 count 200 cells/microliter. Note that patients who are HIV positive are eligible, provided they are under treatment with highly active antiretroviral therapy (HAART) and have a CD4 count ? 200 cells/microliter within 30 days prior to registration. Note also that HIV testing is not required for eligibility for this protocol.
viii. End-stage renal disease (i.e. on dialysis or dialysis has been recommended).
Participants will not be paid for their participation.
Updated on
19 Apr 2024.
Study ID: 1707319235 (IUSCC-0626)
