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

NCT02734069 | Recruiting DMC

• 1 other identifier: INCAN/TOX/CBP
• Study Type: observational
• Target: 132
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer; Sarcopenia; Toxicity

Keywords

carboplatin

Outcome Measures

Primary Outcomes (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

  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

  Determine if the dose of carboplatin-based chemotherapy in patients according to the amount of fat-free mass is directly associated with toxicity

  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

  Basal evaluation

Study Arms (2)

Sarcopenic

Patients with sarcopenia (evaluated according to CT scans) will be followed up through treatment with carboplatin for identification of any toxicity grade 3 or 4 (Common Terminology Criteria of Adverse Events)

Drug: Carboplatin

Non Sarcopenic

Patients without sarcopenia (evaluated according to CT scans) will be followed up through treatment with carboplatin for identification of any toxicity grade 3 or 4 (Common Terminology Criteria of Adverse Events)

Drug: Carboplatin

Interventions

Carboplatin DRUG

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

Also known as: CARBOPLAT

Non Sarcopenic; Sarcopenic

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with advanced NSCLC, as candidates for the first line chemotherapy regimen of carboplatin / paclitaxel or Carboplatin / Pemetrexed

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Instituto Nacional de Cancerologia de Mexico: lead

Study Sites (1)

Instituto Nacional de Cancerologia

Mexico City, 14080, Mexico

RECRUITING

Related Publications (17)

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MeSH Terms

Conditions

Lung Neoplasms; Sarcopenia

Interventions

Carboplatin

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals

Study Officials

• Oscar Arrieta, MD, MSc

  Instituto Nacional de Cancerologia, Columbia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Oscar Arrieta, MD, M Sc

CONTACT

015556280400; ogar@unam.mx

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Thoracic Oncology Unit and Laboratory of Experimental Oncology

Study Record Dates

• First Submitted: March 31, 2016
• First Posted: April 12, 2016
• Study Start: February 1, 2016
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: December 24, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)