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

Primary Purpose

Non Small Cell Lung Cancer

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Image Guided Stereotactic Ablative Radiotherapy
Sponsored by
West Virginia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non Small Cell Lung Cancer focused on measuring Non Small Cell Lung Cancer, Surgically inoperable, Radiation Therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • West Virginia University Hospitals Mary Babb Randolph Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

A - 7.5 Gy x 10 daily fractions

B - 12 Gy x 5 daily fractions

Arm Description

Radiotherapy: 7.5 Gy x 10 daily fractions delivered with VMAT or regular IMRT at West Virginia University.

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

Outcomes

Primary Outcome Measures

Local Control Rate (Absence of Local Progression) Using SABR for Treatment of NSCLC

Secondary Outcome Measures

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)

Full Information

First Posted
September 25, 2014
Last Updated
December 22, 2020
Sponsor
West Virginia University
Collaborators
American Cancer Society, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02262000
Brief Title
Phase II Image Guided Stereotactic Ablative Radiotherapy for Non-Small Cell Lung Cancer
Acronym
SABR
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)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Terminated
Why Stopped
Investigator left institution
Study Start Date
September 2013 (undefined)
Primary Completion Date
July 7, 2016 (Actual)
Study Completion Date
July 10, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
West Virginia University
Collaborators
American Cancer Society, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Small Cell Lung Cancer
Keywords
Non Small Cell Lung Cancer, Surgically inoperable, Radiation Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A - 7.5 Gy x 10 daily fractions
Arm Type
Experimental
Arm Description
Radiotherapy: 7.5 Gy x 10 daily fractions delivered with VMAT or regular IMRT at West Virginia University.
Arm Title
B - 12 Gy x 5 daily fractions
Arm Type
Experimental
Arm Description
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 Type
Radiation
Intervention Name(s)
Image Guided Stereotactic Ablative Radiotherapy
Other Intervention Name(s)
SABR
Primary Outcome Measure Information:
Title
Local Control Rate (Absence of Local Progression) Using SABR for Treatment of NSCLC
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Best Response
Description
To determine the 2-year regional, and distant metastasis rates, progression-free survival (PFS), local progression free survival (L-PFS), overall survival (OS)
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Malcolm Mattes, MD
Organizational Affiliation
West Virginia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
West Virginia University Hospitals Mary Babb Randolph Cancer Center
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26104945
Citation
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.
Results Reference
derived

Learn more about this trial

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

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