Phase II Image Guided Stereotactic Ablative Radiotherapy for Non-Small Cell Lung Cancer

Study Overview
=================
Brief Summary
-----------------
This study will help researchers learn about the best dose of radiation to be used when treating large early stage non-small cell lung cancer (NSCLC) with a treatment called stereotactic ablative radiotherapy (SABR). Current treatments with SABR for early stage NSCLC show positive response. But, for large early stage NSCLC it may be better to give different SABR doses than what is used in routine early stage NSCLC treatment. It is not understood which dose is best for treating large early stage NSCLC. Therefore, this study can help researchers learn if giving a higher dose using SABR over a period of 5-10 treatment days can increase the chance of cure for large early stage NSCLC.

Detailed Description
-----------------
Treatment Plan: 7.5 Gy x 10 daily fractions delivered with volumetric modulated arc therapy (VMAT) or regular intensity-modulated radiation therapy (IMRT). Optional schedule of 12 Gy x 5 daily fractions can may also be used ONLY in situations where dose constraints for organs at risk can be EASILY met while optimal planning target volume (PTV) coverage is achieved; but the 7.5 Gy x 10 daily fractions schedule is preferred. All doses are prescribed to the tumor periphery. For this protocol, patients will be followed only up to 2 years post radiation therapy.

Official Title
-----------------
A Phase II Clinical Trial of Image Guided Stereotactic Ablative Radiotherapy (SABR) for T2 and Microscopic T3 (PL3), N0,M0 Non-small Cell Lung Cancer (NSCLC)

Conditions
-----------------
Non Small Cell Lung Cancer

Intervention / Treatment
-----------------
* Radiation: Image Guided Stereotactic Ablative Radiotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Non-Small Cell Lung Cancer T2N0M0 or T3(PL3)N0M0 or Locally recurrent ≤ 7 cm Surgically inoperable ECOG Performance 0-2 Exclusion Criteria: Pacemaker on the same side of the tumor Pregnant Infection that requires IV antibiotics Concomitant or adjuvant anti-neoplastic chemotherapy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A - 7.5 Gy x 10 daily fractions<br>Radiotherapy: 7.5 Gy x 10 daily fractions delivered with VMAT or regular IMRT at West Virginia University. | Radiation: Image Guided Stereotactic Ablative Radiotherapy<br> <br> * Other names: SABR;|
| Experimental: B - 12 Gy x 5 daily fractions<br>Radiotherapy: Optional schedule of 12 Gy x 5 daily fractions can may also be used ONLY in situations where dose constraints for organs at risk can be EASILY met while optimal PTV coverage is achieved | Radiation: Image Guided Stereotactic Ablative Radiotherapy<br> <br> * Other names: SABR;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Local Control Rate (Absence of Local Progression) Using SABR for Treatment of NSCLC |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best Response | To determine the 2-year regional, and distant metastasis rates, progression-free survival (PFS), local progression free survival (L-PFS), overall survival (OS) | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Non Small Cell Lung Cancer, Surgically inoperable, Radiation Therapy