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
Overview
- Phase
- N/A
- Intervention
- cisplatin
- Conditions
- Recurrent Non-small Cell Lung Cancer
- Sponsor
- Wake Forest University Health Sciences
- Enrollment
- 45
- Locations
- 2
- Primary Endpoint
- Use of the Frailty Index and/or the geriatric assessment in prediction of toxicity
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief 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.
Investigators
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
Arms & Interventions
Supportive Care (frailty index, geriatric assessment, chemo)
Patients complete a frailty index and geriatric assessment prior to beginning chemotherapy. Patients receive standard-of-care chemotherapy comprising carboplatin IV and paclitaxel IV on day 1. Treatment repeats every 21 days for up to 2 courses
Intervention: cisplatin
Supportive Care (frailty index, geriatric assessment, chemo)
Patients complete a frailty index and geriatric assessment prior to beginning chemotherapy. Patients receive standard-of-care chemotherapy comprising carboplatin IV and paclitaxel IV on day 1. Treatment repeats every 21 days for up to 2 courses
Intervention: carboplatin
Supportive Care (frailty index, geriatric assessment, chemo)
Patients complete a frailty index and geriatric assessment prior to beginning chemotherapy. Patients receive standard-of-care chemotherapy comprising carboplatin IV and paclitaxel IV on day 1. Treatment repeats every 21 days for up to 2 courses
Intervention: questionnaire administration
Outcomes
Primary Outcomes
Use of the Frailty Index and/or the geriatric assessment in prediction of toxicity
Time Frame: Prior to chemotherapy