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)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- West Virginia University
- Enrollment
- 3
- Locations
- 1
- Primary Endpoint
- Local Control Rate (Absence of Local Progression) Using SABR for Treatment of NSCLC
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •Infection that requires IV antibiotics
- •Concomitant or adjuvant anti-neoplastic chemotherapy
Arms & Interventions
A - 7.5 Gy x 10 daily fractions
Radiotherapy: 7.5 Gy x 10 daily fractions delivered with VMAT or regular IMRT at West Virginia University.
Intervention: Image Guided Stereotactic Ablative Radiotherapy (Radiation)
B - 12 Gy x 5 daily fractions
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
Intervention: Image Guided Stereotactic Ablative Radiotherapy (Radiation)
Outcomes
Primary Outcomes
Local Control Rate (Absence of Local Progression) Using SABR for Treatment of NSCLC
Time Frame: 2 years
Secondary Outcomes
- Best Response(2 years)