Non-Small Cell Lung Cancer (NSCLC) stage III inoperable
Conditions
Interventions
First stage: It will be compound by one group of treatment
Group I Nimotuzumab+Chemotherapy+Radiotherapy (experimental): Nimotuzumab 200 mg by intravenous route, diluted in 250 mL of 0.9% saline solut
Antibodies, Monoclonal, Humanized
Antibodies, Monoclonal
Drug Therapy
Radiotherapy
Chemoradiotherapy
Cisplatin
Etoposide
Antineoplastic Agents
Administration, Intravenous
Placebos
Nimotuzumab
Sponsors
Center of Molecular Immunology (CIM)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patients who meet the diagnostic criteria. 2. Patients with age greater than or equal to 18 years. 3. Patients who have signed the informed consent for the investigation 4. Patients with functional capacity according to ECOG from 0 to 1. 5. Virgin patients of oncospecific treatment. 6. Patients with life expectancy of more than six months. 7. Patients with normal hepatic, renal and hematologic functions defined by: • Hemoglobin greater than and equal to 90 g / L (patients with lower Hb levels should be transfused prior to inclusion) • Total Leukocyte count greater than and equal to 3.0 x 109 / L • Absolute Neutrophil count greater than and equal to 1.5 x 109 / L • Absolute Eosinophil count with any value. • Concentrations of EGF with any value. • Platelet count greater and equal 100 x 109 / L • Bilirubin up to the normal upper limit. • TGP and TGO: up to and less than 1.5 times the upper limit for the normal value of the institution, or 50 mL / min / 1.73 m2 for patients with creatinine levels above the normal value of the institution.
Exclusion criteria
Exclusion criteria: 1. Patients who have previously received onco-specific treatment. 2. Patients with acute, chronic, or inflammatory decompensated infectious diseases. 3. Patients of childbearing age who do not accept to use adequate contraceptive methods (intrauterine devices, barrier or tubal ligation methods, hormonal methods). 4. Pregnant or lactating patients. 5. Patients with acute allergic states or history of severe allergic reactions. 6. Patients that are not tributaries of receiving onco-specific treatment. 7. Patients with Brain Metastases.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Survival (Time from randomization until death from any cause). Measurement time: until 24 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Quality of life (EORTC QLQ-C30 (v. 3) questionnaire). Measurement time: At baseline, 3, 6, 9, 12, 15, 18, 21 and 24 months. 2.Adverse events-AE (Description of AE (Name of the AE); Intensity of the AE (Mild, Moderate, Severe, Life-threatening consequences, Death); Seriousness of the AE (Serious, Not serious); Causality relationship (Very probable, Probable, Possible, Improbable, Not related, Not evaluable); Attitude towards treatment (Temporary interruption, Definitive interruption, Modification of doses, No change), Result of AE (Reversible effect, Irreversible effect, Death, Loss of follow-up)). Measurement time: until 24 months. 3. Antitumor response (It will be classified in Complete response, Partial response, Stable disease, Progressive disease according to RECIST criteria). Measurement time: At baseline, 3, 6, 9, 12, 15, 18, 21 and 24 months. 4. EGF concentrations: (Values in pico grams using serum levels through an ELISA). Measurement time: at baseline, 3, 6, 9 and 12 months. 5. Values of platelet count (Absolute values from serum measurements). Measurement time: at baseline, 3, 6, 9 and 12 months. 6. Progression-Free Survival (Time from treatment start until objective tumor progression or death from any cause). Measurement time: until 24 months. | — |
Countries
Cuba
Contacts
Public ContactMayra Ramos-Suzarte
Center of Molecular Immunology (CIM)
Outcome results
None listed