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A Single-center Study to Evaluate the Feasibility of a Novel NA-NOSE for Monitoring Response to and Detecting Recurrence After Surgery or Radiation in Early Stage Lung Cancer


N/A
18 Years
N/A
Open (Enrolling)
Both
Stage IA Non-small Cell Lung Cancer, Stage IB Non-small Cell Lung Cancer, Stage IIA Non-small Cell Lung Cancer, Stage IIB Non-small Cell Lung Cancer

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Trial Information

A Single-center Study to Evaluate the Feasibility of a Novel NA-NOSE for Monitoring Response to and Detecting Recurrence After Surgery or Radiation in Early Stage Lung Cancer


PRIMARY OBJECTIVES:

I. Determine if a suitable fraction of patients become NA-NOSE negative within three years
post treatment. We will test the hypothesis that this fraction is at most 30% versus the
alternative that it is at least 50%.

SECONDARY OBJECTIVES:

I. Determine if patients who become NA-NOSE negative post treatment then become NA-NOSE
positive prior to clinical recurrence.

II. Estimate the time post treatment needed to become NA-NOSE negative. III. Estimate the
lead time gained between a negative to positive NA-NOSE transition and clinical recurrence.

OUTLINE:

Patients undergo breath sample collection for the NA-NOSE breath test at baseline (2
pre-treatment samples), at 6 and 12 weeks post-treatment, and then every 3 months for up to
3 years in the absence of disease progression.


Inclusion Criteria:



- Patients must have histologically or cytologically confirmed stage I or II non-small
cell lung cancer based on the AJCC, 7th edition criteria or have suspicious nodules
which are going to be surgically resected prior to confirming malignancy

- Patients must be deemed to be eligible candidates for either surgery or stereotactic
radiation

- Stereotactic radiation treatment of stage I disease or adjuvant chemotherapy is
allowed at the discretion of treating physician for the participating subject

- Patient who will have surgical resections must consent to the use of post-surgery
tumor samples for correlative molecular studies

- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2

- Ability to travel to appointments and willingness to participate in this study

- Ability to understand and willingness to sign a written information consent and
Health Insurance Portability and Accountability Act (HIPAA) consent document

Exclusion Criteria:

- Patients who have had a prior lung cancer recurrence within the last five years from
the current diagnosis

- Patients having a prior malignancy within the past 3 years other than complete
resection of basal or squamous cell carcinoma of the skin, any in situ malignancy, or
low-risk prostate cancer after curative therapy

- Patients with any prior systemic therapy for the current diagnosis of lung cancer

- Patients with a diagnosis of advanced stage disease (stage III or IV)

- Patients who are unable to comply with study and/or follow up procedures

- Patients who have uncontrolled intercurrent illness including, but not limited to
psychiatric illness/social situations that would limit compliance with study
requirements

- Patients who are pregnant or are breast feeding

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Successful evaluation of gas samples taken from lung cancer patients

Outcome Time Frame:

Up to 3 years

Safety Issue:

No

Principal Investigator

Hossein Borghaei

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fox Chase Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

OER-TH-040

NCT ID:

NCT01840150

Start Date:

August 2012

Completion Date:

Related Keywords:

  • Stage IA Non-small Cell Lung Cancer
  • Stage IB Non-small Cell Lung Cancer
  • Stage IIA Non-small Cell Lung Cancer
  • Stage IIB Non-small Cell Lung Cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms
  • Recurrence

Name

Location

Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111