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

Not Applicable

Terminated

• Conditions: Non Small Cell Lung Cancer
• Interventions: Radiation: Image Guided Stereotactic Ablative Radiotherapy

• Registration Number: NCT02262000
• Lead Sponsor: West Virginia University

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 Timeline

• Study Start: 2013-09
• Study First Submitted: 2014-09-25
• Study First Submitted QC: 2014-10-06
• Study First Posted: 2014-10-10
• Primary Completion: 2016-07-07
• Study Completion: 2017-07-10
• Status Verified: 2020-12
• Results First Submitted: 2020-12-22
• Results First Submitted QC: 2020-12-22
• Last Update Submitted: 2020-12-22
• Results First Posted: 2021-01-22
• Last Update Posted: 2021-01-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
A - 7.5 Gy x 10 daily fractions	Image Guided Stereotactic Ablative Radiotherapy	Radiotherapy: 7.5 Gy x 10 daily fractions delivered with VMAT or regular IMRT at West Virginia University.
B - 12 Gy x 5 daily fractions	Image Guided Stereotactic Ablative Radiotherapy	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

Primary Outcome Measures

Name	Time	Method
Local Control Rate (Absence of Local Progression) Using SABR for Treatment of NSCLC	2 years

Secondary Outcome Measures

Name	Time	Method
Best Response	2 years	To determine the 2-year regional, and distant metastasis rates, progression-free survival (PFS), local progression free survival (L-PFS), overall survival (OS)

Trial Locations

Locations (1)

West Virginia University Hospitals Mary Babb Randolph Cancer Center; 🇺🇸 Morgantown, West Virginia, United States