About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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)
Trial population
Patients with advanced NSCLC, as candidates for the first line chemotherapy regimen of carboplatin / paclitaxel or Carboplatin / Pemetrexed
Trial design
Cohort
Prospective
Treatments tested in this trial
Carboplatin
DrugPatients will receive carboplatin according to the carboplatin area under the curve dose calculation for 2 cycles to evaluate toxicity.
Treatment groups
Trial outcomes
Primary outcomes
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Determine if the dose of carboplatin-based chemotherapy in patients according to the amount of fat-free mass is directly associated with toxicity
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Determine if the dose of carboplatin-based chemotherapy in patients according to the amount of fat-free mass is directly associated with toxicity
Secondary outcomes
Compare different formulas to calculate Glomerular Filtration Rate taking as gold standard cystatin c
Calculate the glomerular filtration rate given the amount of fat-free mass (MSA-eCrCl) and correlate with cystatin C and formulas as Cockroft-Gault, Levey, The Modification of Diet in Renal Disease (MDRD) and Chronic kidney disease epidemiology collaboration (CKD-EPI).
Sponsors and contacts
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