NCT02734069 Impact of Fat-free Mass in the Carboplatin Calculated Dose and Chemotherapeutic Toxicity in Patients With Advanced NSCLC
| NCT ID | NCT02734069 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Instituto Nacional de Cancerologia de Mexico |
| Condition | Lung Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 132 participants |
| Start Date | 2016-02 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 132 participants in total. It began in 2016-02 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 in advanced NSCLC.
Eligibility Criteria
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)
Contact & Investigator
Oscar Arrieta, MD, MSc
PRINCIPAL INVESTIGATOR
Instituto Nacional de Cancerologia, Columbia
Frequently Asked Questions
Who can join the NCT02734069 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Lung Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT02734069 currently recruiting?
Yes, NCT02734069 is actively recruiting participants. Contact the research team at ogar@unam.mx for enrollment information.
Where is the NCT02734069 trial being conducted?
This trial is being conducted at Mexico City, Mexico.
Who is sponsoring the NCT02734069 clinical trial?
NCT02734069 is sponsored by Instituto Nacional de Cancerologia de Mexico. The principal investigator is Oscar Arrieta, MD, MSc at Instituto Nacional de Cancerologia, Columbia. The trial plans to enroll 132 participants.
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