An Alternative Radiation Fractionation Strategy for Locally Advanced Non-Small Cell Lung Cancer (NSCLC)
18 Years
80 Years
Both
Stage IIA Non-small Cell Lung Cancer, Stage IIB Non-small Cell Lung Cancer, Stage IIIA Non-small Cell Lung Cancer, Stage IIIB Non-small Cell Lung Cancer
Trial Information
An Alternative Radiation Fractionation Strategy for Locally Advanced Non-Small Cell Lung Cancer (NSCLC)
PRIMARY OBJECTIVES:
I. To test the safety and tolerability of an alternative fractionation regimen in locally
advanced non-small cell lung cancer (NSCLC), consisting of 44 Gy with concurrent
chemotherapy followed by a stereotactic body radiation therapy (SBRT) boost to remaining
parenchymal and nodal disease. The maximum tolerated dose of the SBRT boost will be
determined.
SECONDARY OBJECTIVES:
I. To assess local control. II. To assess distant metastasis and patterns of failure. III.
To assess overall survival at 1 and 2 years.
OUTLINE: This is a dose-escalation study of radiation therapy and SBRT.
Patients undergo radiation therapy daily and receive carboplatin and paclitaxel weekly for
4.5 weeks. Patients then undergo 2 boost SBRT treatments 2-3 days apart.
After completion of study treatment, patients are followed up for 5 years.
Inclusion Criteria:
- Biopsy proven NSCLC
- Unresectable disease
- Clinical stage T1-T4, N1-3, M0
- Karnofsky performance status (KPS) >= 70
Exclusion Criteria:
- Prior history of lung cancer
- Pregnancy
- Prior history of radiation to the chest
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Maximum tolerated dose (MTD) defined to be the dose level that results in a probability equal to 0.33 that a dose limiting toxicity (DLT) will be manifest using Common Terminology Criteria for Adverse Events (CTCAE) version 4 (v.4)
Outcome Time Frame:
Up to 1 year
Safety Issue:
Yes
Principal Investigator
Kristin Higgins
Investigator Role:
Principal Investigator
Investigator Affiliation:
Emory University
Authority:
United States: Food and Drug Administration
Study ID:
IRB00056552
NCT ID:
NCT01711697
Start Date:
September 2012
Completion Date:
September 2015
Related Keywords:
- Stage IIA Non-small Cell Lung Cancer
- Stage IIB Non-small Cell Lung Cancer
- Stage IIIA Non-Small Cell Lung Cancer
- Stage IIIB Non-Small Cell Lung Cancer
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
Name | Location |
|---|---|
| Emory University | Atlanta, Georgia 30322 |
