RecruitingNCT02734069
Impact of Fat-free Mass in the Carboplatin Calculated Dose and Chemotherapeutic Toxicity in Patients With Advanced NSCLC
Impact of Fat-free Mass in the Carboplatin Calculated Dose and Chemotherapeutic Toxicity in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)
Sponsor
Instituto Nacional de Cancerologia de Mexico
Enrollment
132 participants
Start Date
Feb 1, 2016
Study Type
OBSERVATIONAL
Conditions
Summary
This study evaluate the association of body composition (mainly free-fat mass), clinical and biochemical parameters with development of toxicity in patients under treatment with Carboplatin/Paclitaxel in advanced NSCLC.
Eligibility
Min Age: 18 Years
Inclusion Criteria5
- Diagnosis of NSCLC Stage IV (stratification according to the American Joint Committee on Cancers - 7th edition)
- Candidates for treatment with carboplatin plus paclitaxel 1st line
- Performance status (ECOG 0-2)
- Laboratory studies that demonstrate adequate renal, hepatic and hematologic function (blood chemistry and blood count)
- Normal renal ultrasound prior to initiation of treatment
Exclusion Criteria7
- Patients with renal impairment (KDOQI 3-5)
- Patients who do not have computed tomography study at baseline
- Uncontrolled blood pressure (\> 140 mmHg)
- Uncontrolled diabetes (\> 130 mg / dL)
- Obstruction in kidney (s) or ureter (s)
- Dehydrated patients
- Patients with high consumption of NSAIDs (aspirin, ibuprofen, etc.\> 1 month)
Interventions
DRUGCarboplatin
Patients will receive carboplatin according to the carboplatin area under the curve dose calculation for 2 cycles to evaluate toxicity.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT02734069
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