Overview

This trial is active, not recruiting.

Condition non small cell lung cancer
Treatment image guided stereotatic ablative radiotherapy
Phase phase 2
Sponsor West Virginia University
Collaborator American Cancer Society, Inc.
Start date September 2013
End date December 2016
Trial size 40 participants
Trial identifier NCT02262000, WVU010513

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Radiotherapy: 7.5 Gy x 10 daily fractions delivered with VMAT or regular IMRT at West Virginia University.
image guided stereotatic ablative radiotherapy SABR
(Experimental)
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
image guided stereotatic ablative radiotherapy SABR

Primary Outcomes

Measure
Local Control Rate (absence of local progression) using SABR for treatment of NSCLC
time frame: 2 years

Secondary Outcomes

Measure
Best Response
time frame: 2 years

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

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)
Principal investigator Malcolm Mattes, MD
Description Treatment Plan: 7.5 Gy x 10 daily fractions delivered with VMAT or regular 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 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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by West Virginia University.