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

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Summary

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

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Full Description

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.

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Eligibility Criteria

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

Study is for people with:

Lung Cancer

Estimated Enrollment:

45

Study ID:

NCT01026467

Recruitment Status:

Completed

Sponsor:

Wake Forest University Health Sciences

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There are 2 Locations for this study

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Syracuse VA Medical Center
Syracuse New York, 13210, United States
Wake Forest University Health Sciences
Winston-Salem North Carolina, 27157, United States

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Estimated Enrollment:

45

Study ID:

NCT01026467

Recruitment Status:

Completed

Sponsor:


Wake Forest University Health Sciences

How clear is this clinincal trial information?

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