RecruitingNot Applicable

Impact of Fat-free Mass in the Carboplatin Calculated Dose and Chemotherapeutic Toxicity in Patients With Advanced NSCLC

Mexico132 participantsStarted 2016-02

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

Timeframe: Three weeks after the application of chemotherapy to detect changes from Baseline

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

Timeframe: Six weeks after the application of chemotherapy to detect changes from Baseline

Trial details

NCT IDNCT02734069

SponsorInstituto Nacional de Cancerologia de Mexico

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-12

Contact for this trial

Oscar Arrieta, MD, M Sc

015556280400 ogar@unam.mx

View on ClinicalTrials.gov More Lung Cancer trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

Timeframe: Three weeks after the application of chemotherapy to detect changes from Baseline

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

Timeframe: Six weeks after the application of chemotherapy to detect changes from Baseline