Frailty Index and Geriatric Assessment in Predicting Toxicity to Front-Line Chemotherapy in Treating Patients With Stage IV Non-Small Cell Lung Cancer

Wake Forest University Health Sciences45 enrolled

Overview

This phase II trial is studying how well a frailty index and geriatric assessment works in predicting toxicity to front-line chemotherapy in treating patients with stage IV non-small cell lung cancer. A frailty index and geriatric assessment prior to treatment may help identify a better treatment regimen

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Recurrent Non-small Cell Lung Cancer Stage IV Non-small Cell Lung Cancer

Interventions

cisplatinDRUG

Given IV

carboplatinDRUG

Given IV

questionnaire administrationOTHER

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (2)

Syracuse VA Medical Center

Syracuse, New York, United States

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

Outcomes

Primary Outcomes

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

Time frame: Prior to chemotherapy

Data from ClinicalTrials.gov

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