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An Alternative Radiation Fractionation Strategy for Locally Advanced Non-Small Cell Lung Cancer (NSCLC)


Phase 1
18 Years
80 Years
Open (Enrolling)
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

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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