Status:
RECRUITING
Impact of Fat-free Mass in the Carboplatin Calculated Dose and Chemotherapeutic Toxicity in Patients With Advanced NSCLC
Lead Sponsor:
Instituto Nacional de Cancerologia de Mexico
Conditions:
Lung Cancer
Sarcopenia
Eligibility:
All Genders
18+ years
Brief 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...
Detailed Description
BACKGROUND Lung cancer (LC) is the leading cause of cancer deaths worldwide, are attributed about 13% of all new cases of cancer and accounts for 19.4% of deaths from malignancies. In Mexico, this ca...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
February 1 2016
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
132 Patients enrolled
Trial Details
Trial ID
NCT02734069
Start Date
February 1 2016
End Date
December 1 2027
Last Update
December 24 2025
Active Locations (1)
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1
Instituto Nacional de Cancerologia
Mexico City, Mexico, 14080