Carboplatin: Patients will receive carboplatin according to the carboplatin area under the curve dose calculation for 2 cycles to evaluate toxicity.
Study 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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* 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 Criteria:
* 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)
Primary outcome measure(s)
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 — Three weeks after the application of chemotherapy to detect changes from Baseline 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 — Six weeks after the application of chemotherapy to detect changes from Baseline Determine if the dose of carboplatin-based chemotherapy in patients according to the amount of fat-free mass is directly associated with toxicity
Trial sites (1)
Facility
City
Region
Status
Instituto Nacional de Cancerologia
Mexico City
Mexico
Recruiting
More Instituto Nacional de Cancerologia de Mexico trials in Mexico
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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