NCT01026467

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 45 (actual)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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

Detailed 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.

Conditions

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

Interventions

Type	Name	Description
DRUG	cisplatin	Given IV
DRUG	carboplatin	Given IV
OTHER	questionnaire administration

Timeline

• Start date: 2010-01-01
• Primary completion: 2014-05-01
• Completion: 2014-05-01
• First posted: 2009-12-04
• Last updated: 2018-07-05

Locations

2 sites across 1 country: United States