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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorInstituto Nacional de Cancerologia de Mexico

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Carboplatin

    Drug

    Patients will receive carboplatin according to the carboplatin area under the curve dose calculation for 2 cycles to evaluate toxicity.

Treatment groups

132 Participants
are divided into 2 treatment groups
Group A: Sarcopenic1 intervention
Group B: Non Sarcopenic1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
Three weeks after the application of chemotherapy to detect changes from Baseline
2

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

Time frame
Six weeks after the application of chemotherapy to detect changes from Baseline

Secondary outcomes

1

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).

Time frame
Basal evaluation

Other outcomes

Sponsors and contacts

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