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

December 22, 2020 updated by: West Virginia University

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional 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
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
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Best Response
Time Frame: 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)
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

West Virginia University

Collaborators

American Cancer Society, Inc.

Investigators

  • Principal Investigator: Malcolm Mattes, MD, West Virginia University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WVU010513

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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