NCT02262000

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

September 25, 2014

Completed
15 days until next milestone

First Posted

Study publicly available on registry

October 10, 2014

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 7, 2016

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 10, 2017

Completed
3.5 years until next milestone

Results Posted

Study results publicly available

January 22, 2021

Completed
Last Updated

January 22, 2021

Status Verified

December 1, 2020

Enrollment Period

2.8 years

First QC Date

September 25, 2014

Results QC Date

December 22, 2020

Last Update Submit

December 22, 2020

Conditions

Non Small Cell Lung Cancer

Keywords

Non Small Cell Lung CancerSurgically inoperableRadiation Therapy

Outcome Measures

Primary Outcomes (1)

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

    2 years

Secondary Outcomes (1)

  • Best Response

    2 years

Study Arms (2)

A - 7.5 Gy x 10 daily fractions

EXPERIMENTAL

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

Radiation: Image Guided Stereotactic Ablative Radiotherapy

B - 12 Gy x 5 daily fractions

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

Radiation: Image Guided Stereotactic Ablative Radiotherapy

Interventions

Image Guided Stereotactic Ablative RadiotherapyRADIATION
Also known as: SABR
A - 7.5 Gy x 10 daily fractionsB - 12 Gy x 5 daily fractions

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Non-Small Cell Lung Cancer
  • T2N0M0 or T3(PL3)N0M0 or Locally recurrent ≤ 7 cm
  • Surgically inoperable
  • ECOG Performance 0-2

You may not qualify if:

  • Pacemaker on the same side of the tumor
  • Pregnant
  • Infection that requires IV antibiotics
  • Concomitant or adjuvant anti-neoplastic chemotherapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

West Virginia University Hospitals Mary Babb Randolph Cancer Center

Morgantown, West Virginia, 26506, United States

Location

Related Publications (1)

  • 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.

    PMID: 26104945DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Results Point of Contact

Title
Clinical Trials Compliance Coordinator
Organization
West Virginia Universtiy, WVCTSI
ctgovadmin@hsc.wvu.edu
304-293-0216

Study Officials

  • Malcolm Mattes, MD

    West Virginia University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 25, 2014

First Posted

October 10, 2014

Study Start

September 1, 2013

Primary Completion

July 7, 2016

Study Completion

July 10, 2017

Last Updated

January 22, 2021

Results First Posted

January 22, 2021

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)