Non Small Cell Lung Cancer
Conditions
Brief summary
The purpose of this study is to determine if a single treatment of targeted radiation (called SBRT or Stereotactic Body Radiation Therapy) can be as safe and effective as multiple doses of radiation in patients with central non-small cell lung cancer
Interventions
RADIATIONSBRT
SBRT for central non small cell lung cancer
Sponsors
Roswell Park Cancer Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Have an ECOG Performance Status of ≤ 2. Refer to Appendix A. * Have histologically proven diagnosis of non-small cell lung cancer (NSCLC). * Stage cT1-3N0M0 with tumor size \< 6 cm. * Prior systemic therapy allowed but no systemic therapy 4-6 weeks prior to stereotactic body radiation therapy SBRT (see
Exclusion criteria
), during SBRT, or 2 weeks after SBRT. * Tumors located within 2 cm in all directions of any mediastinal critical structures, including the bronchial tree, esophagus, heart, brachial plexus, major vessels, spinal cord, phrenic nerve, and recurrent laryngeal nerve, as defined by the International Association for the Study of Lung Cancer (IASLC) (27). * Participant is considered to be either medically or surgically inoperable by physicians, or participant declines surgery. * Participants of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. * Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of grade 3-5 adverse events | Up to 5 years | Rates of treatment related grade 3-5 adverse events. Assessed using CTCAE v.5 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free Survival | Up to 5 years | Progression free is defined as time from initiation of SBRT to disease progression or death from any cause. Estimated by the Kaplan-Meier method. |
| Overall Survival | UP to 5 years | Overall Survival is defined as time from initiation of SBRT to patient death from any cause. Estimated by the Kaplan-Meier method. |
| Quality of life scores | Up to 5 years | Comparison of QoL scores between time points will be made using the Wilcoxon signed rank test |
| Local Control Rate | Up to 5 years | Local control is defined as absence of local failure among patients evaluable for efficacy |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAnurag Singh, MD
Roswell Park Comprehensive Cancer Center
Outcome results
None listed