Clinical trial · Observational
Impact of Fat-free Mass in the Carboplatin Calculated Dose and Chemotherapeutic Toxicity in Patients With Advanced NSCLC
Impact of Fat-free Mass in the Carboplatin Calculated Dose and Chemotherapeutic Toxicity in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)
NCT02734069CI-TRIAL-00099659recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Sarcopenia | — | UNRESOLVED | — |
| Toxicity | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carboplatin | Drug | Carboplatin | ALIAS |
Design
Arms and outcomes
Arms (2)
- label
- Sarcopenic
- description
- 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)
- interventionNames
- Drug: Carboplatin
- label
- Non Sarcopenic
- description
- 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)
- interventionNames
- Drug: Carboplatin
Primary outcomes (2)
- measure
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (17)
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- BACKGROUNDCullen MH, Billingham LJ, Woodroffe CM, Chetiyawardana AD, Gower NH, Joshi R, Ferry DR, Rudd RM, Spiro SG, Cook JE, Trask C, Bessell E, Connolly CK, Tobias J, Souhami RL. Mitomycin, ifosfamide, and cisplatin in unresectable non-small-cell lung cancer: effects on survival and quality of life. J Clin Oncol. 1999 Oct;17(10):3188-94. doi: 10.1200/JCO.1999.17.10.3188. PMID 10506617
- BACKGROUNDSchiller JH, Harrington D, Belani CP, Langer C, Sandler A, Krook J, Zhu J, Johnson DH; Eastern Cooperative Oncology Group. Comparison of four chemotherapy regimens for advanced non-small-cell lung cancer. N Engl J Med. 2002 Jan 10;346(2):92-8. doi: 10.1056/NEJMoa011954. PMID 11784875
- BACKGROUNDGronberg BH, Bremnes RM, Flotten O, Amundsen T, Brunsvig PF, Hjelde HH, Kaasa S, von Plessen C, Stornes F, Tollali T, Wammer F, Aasebo U, Sundstrom S. Phase III study by the Norwegian lung cancer study group: pemetrexed plus carboplatin compared with gemcitabine plus carboplatin as first-line chemotherapy in advanced non-small-cell lung cancer. J Clin Oncol. 2009 Jul 1;27(19):3217-24. doi: 10.1200/JCO.2008.20.9114. Epub 2009 May 11. PMID 19433683
- BACKGROUNDGordon JN, Green SR, Goggin PM. Cancer cachexia. QJM. 2005 Nov;98(11):779-88. doi: 10.1093/qjmed/hci127. Epub 2005 Oct 7. PMID 16214835