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A Phase II Study of Fraility Index and Geriatric Assessment as Predictors of Toxicity to Front-Line Chemotherapy in Patients With Stage IV Non-Small Cell Lung Cancer


Phase 2
N/A
N/A
Open (Enrolling)
Both
Recurrent Non-small Cell Lung Cancer, Stage IV Non-small Cell Lung Cancer

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Trial Information

A Phase II Study of Fraility Index and Geriatric Assessment as Predictors of Toxicity to Front-Line Chemotherapy in Patients With Stage IV Non-Small Cell Lung Cancer


PRIMARY OBJECTIVE:

I. To determine the correlation of the data from the frailty index and geriatric assessment
tool with the level of toxicity encountered in the first two cycles of therapy.

OUTLINE:

Patients complete a frailty index and geriatric assessment prior to beginning chemotherapy.
Patients receive standard-of-care chemotherapy comprising carboplatin intravenously (IV) and
paclitaxel IV on day 1. Treatment repeats every 21 days for up to 2 courses.


Inclusion Criteria:



Pathological documentation of non-small cell lung cancer Stage IV disease Prior adjuvant
chemotherapy for the earlier stages of non-small cell lung cancer is allowed Patients with
brain metastases are allowed on protocol only if they have received brain irradiation and
are neurologically stable Patients with other malignancies are allowed on protocol unless
they are receiving active treatment (surgery, radiation, chemotherapy or immunotherapy)
for the other malignancy Ability to understand and the willingness to sign a written
informed consent document

Exclusion Criteria:

Prior palliative chemotherapy Pregnant and/or lactating women Prior radiation therapy
other than brain irradiation for brain metastases

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Use of the Frailty Index and/or the geriatric assessment in prediction of toxicity

Outcome Time Frame:

Prior to chemotherapy

Safety Issue:

Yes

Principal Investigator

Heidi Klepin

Investigator Role:

Principal Investigator

Investigator Affiliation:

Comprehensive Cancer Center of Wake Forest University

Authority:

United States: Institutional Review Board

Study ID:

CCCWFU 98709

NCT ID:

NCT01026467

Start Date:

January 2010

Completion Date:

Related Keywords:

  • Recurrent Non-Small Cell Lung Cancer
  • Stage IV Non-Small Cell Lung Cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Wake Forest University Health SciencesWinston-Salem, North Carolina  27157
Syracuse VA Medical CenterSyracuse, New York  13210