Frailty Index and Geriatric Assessment in Predicting Toxicity to Front-Line Chemotherapy in Treating Patients With Stage IV Non-Small Cell Lung Cancer
Status: | Completed |
---|---|
Conditions: | Lung Cancer, Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | Any |
Updated: | 4/6/2017 |
Start Date: | January 2010 |
End Date: | May 2014 |
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
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
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.
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
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Winston-Salem, North Carolina 27157
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