A Pilot Study of Single Fraction Stereotactic Body Radiation Therapy (SBRT) in Central Non-Small Cell Lung Cancer
- Conditions
- Non Small Cell Lung Cancer
- Registration Number
- NCT05138900
- Lead Sponsor
- Roswell Park Cancer Institute
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria:<br><br> - Have an ECOG Performance Status of = 2. Refer to Appendix A.<br><br> - Have histologically proven diagnosis of non-small cell lung cancer (NSCLC).<br><br> - Stage cT1-3N0M0 with tumor size < 6 cm.<br><br> - Prior systemic therapy allowed but no systemic therapy 4-6 weeks prior to<br> stereotactic body radiation therapy SBRT (see exclusion criteria), during SBRT, or 2<br> weeks after SBRT.<br><br> - Tumors located within 2 cm in all directions of any mediastinal critical structures,<br> including the bronchial tree, esophagus, heart, brachial plexus, major vessels,<br> spinal cord, phrenic nerve, and recurrent laryngeal nerve, as defined by the<br> International Association for the Study of Lung Cancer (IASLC) (27).<br><br> - Participant is considered to be either medically or surgically inoperable by<br> physicians, or participant declines surgery.<br><br> - Participants of child-bearing potential must agree to use adequate contraceptive<br> methods (e.g., hormonal or barrier method of birth control; abstinence) prior to<br> study entry.<br><br>Should a woman become pregnant or suspect she is pregnant while she or her partner is<br>participating in this study, she should inform her treating physician immediately.<br><br> - Participant must understand the investigational nature of this study and sign an<br> Independent Ethics Committee/Institutional Review Board approved written informed<br> consent form prior to receiving any study related procedure<br><br>Exclusion Criteria:<br><br> - Contraindication to stereotactic body radiation therapy (SBRT) (including the<br> inability to cooperate with any aspect of SBRT such as the inability to lie still<br> and breathe reproducibly)<br><br> - Prior radiation to the volume of lung or mediastinum currently involved by tumor<br><br> - Plan for the patient to receive other concomitant antineoplastic therapy (including<br> standard fractionated radiation, chemotherapy, biological therapy, vaccine therapy,<br> and surgery) while on this protocol, except at disease progression<br><br> - Received an investigational agent within 30 days prior to enrollment<br><br> - Participants who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for<br> nitrosoureas or mitomycin C) prior to entering the study or those who have not<br> recovered from adverse events due to agents administered more than 4 weeks earlier.<br><br> - Participants with known brain metastases should be excluded from this clinical trial<br> because of their poor prognosis and because they often develop progressive<br> neurologic dysfunction that would confound the evaluation of neurologic and other<br> adverse events.<br><br> - Uncontrolled intercurrent illness including, but not limited to, ongoing or active<br> infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac<br> arrhythmia, or psychiatric illness/social situations that would limit compliance<br> with study requirements.<br><br> - Pregnant or nursing female participants.<br><br> - Unwilling or unable to follow protocol requirements.<br><br> - Any condition which in the Investigator's opinion deems the participant an<br> unsuitable candidate to receive SBRT
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Rate of grade 3-5 adverse events
- Secondary Outcome Measures
Name Time Method Progression-free Survival;Overall Survival;Quality of life scores;Local Control Rate