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

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)

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.

Study Overview

• Status: Terminated
• Conditions: Non Small Cell Lung Cancer
• Intervention / Treatment: Radiation: Image Guided Stereotactic Ablative Radiotherapy

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 Type: Interventional
• Enrollment (Actual): 3
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • West Virginia
    • Morgantown, West Virginia, United States, 26506
      • West Virginia University Hospitals Mary Babb Randolph Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Radiation: Image Guided Stereotactic Ablative Radiotherapy; Other Names: SABR
Experimental: 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	Radiation: Image Guided Stereotactic Ablative Radiotherapy; Other Names: SABR

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: West Virginia University
• Collaborators: American Cancer Society, Inc.
• Investigators: Principal Investigator: Malcolm Mattes, MD, West Virginia University

Publications and helpful links

General Publications

• Levy A, Guckenberger M, Hurkmans C, Nestle U, Belderbos J, De Ruysscher D, Faivre-Finn C, Le Pechoux C. SBRT Dose and Survival in Non-Small Cell Lung Cancer: In Regard to Koshy et al. Int J Radiat Oncol Biol Phys. 2015 Jul 15;92(4):945-6. doi: 10.1016/j.ijrobp.2015.03.032. No abstract available.

Study record dates

Study Major Dates

• Study Start: September 1, 2013
• Primary Completion (Actual): July 7, 2016
• Study Completion (Actual): July 10, 2017

Study Registration Dates

• First Submitted: September 25, 2014
• First Submitted That Met QC Criteria: October 6, 2014
• First Posted (Estimate): October 10, 2014

Study Record Updates

• Last Update Posted (Actual): January 22, 2021
• Last Update Submitted That Met QC Criteria: December 22, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: Non Small Cell Lung Cancer; Radiation Therapy; Surgically inoperable
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: WVU010513

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO