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

Non Small Cell Lung Cancer Clinical Trial

— 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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02262000
• Other study ID #: WVU010513
• Status: Terminated
• Phase: N/A
• Start date: September 2013
• Est. completion date: July 10, 2017

Study information

• Verified date: December 2020
• Source: West Virginia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: July 10, 2017
• Est. primary completion date: July 7, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non Small Cell Lung Cancer

Intervention

Radiation:
• Image Guided Stereotactic Ablative Radiotherapy

Locations

Country	Name	City	State
United States	West Virginia University Hospitals Mary Babb Randolph Cancer Center	Morgantown	West Virginia

Sponsors (2)

Lead Sponsor	Collaborator
West Virginia University	American Cancer Society, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Local Control Rate (Absence of Local Progression) Using SABR for Treatment of NSCLC		2 years
Secondary	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