Inoperable esophageal tumors of epithelial origin, located in cervical esophagus or intra-thoracic (upper thoracic portion or half) of new diagnosis, relapse or progression. inoperable tumors of the esophagus
Conditions
Interventions
Experimental group (Nimotuzumab): 200 mg intravenous infusion in induction and maintenance scheme
Induction: 200 mg once per week for 6 weeks.
Maintenance: 200mg every 14 days while the patient not s
Antibodies, Monoclonal, Humanized
Drug Therapy
Radiotherapy Chemoradiotherapy
Antibodies, Monoclonal
Induction Chemotherapy
Administration, Intravenous
Nimotuzumab
Sponsors
Center of Molecular Immunology (CIM)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patients who met the diagnostic criteria. 2. Patient express written participate in the study by signing the informed voluntary consent. 3. Patient aged = 18 years. 4. Life expectancy equal to or greater than 6 months. 5. Clinical status as criteria ECOG = 2
Exclusion criteria
Exclusion criteria: 1. Pregnancy, postpartum and breastfeeding 2. Patients with a second tumor concomitant with the exception of basal or squamous cell skin carcinoma in situ and neck carcinoma treated or diagnosed by CT brain metastasis, progression or uncontrolled. 3. Presence of chronic disease or uncontrolled intercurrent (including active infections, symptomatic congestive heart failure, unstable angina, cardiac arrhythmia and psychiatric or social diseases that may limit adherence to clinical trial requirements), or congenital or acquired immunodeficiency at the time of inclusion. 4. Known hypersensitivity to any component of the Nimotuzumab formulation. 5. Presence of allergic conditions or septic acute or severe processes. 6. The patient has received prior treatment with Nimotuzumab or other biological therapy 6 months prior to enrollment, or is receiving other investigational product.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of serious adverse events (serious) with causality relationship with the product under study (Very likely, probable or possible). Measuring time: 2 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety 1. Occurrence of any Adverse Event-AE: (yes/ no). Measuring time: 2 years 2. AE description (Name of the adverse event). Measuring time: 2 years 3. Duration of the AE (Difference between the start date and the completion of the event). Measuring time: 2 years 4. Intensity of AE (Common Toxicity Criteria (CTCAE) version 4.0. 1. Light, 2.Moderate, 3.Severe, 4.Very severe, 5.Death). Measuring time: 2 years 5. Gravity (Seriousness): Critical event / No serious. Measuring time: 2 years 6. Causality relationship (1.Very likely 2.Likely 3.Possible, 4. Unlikely, 5.Unrelated, 6.Unknown). Measuring time: 2 years 7. Attitude towards drug (1. No change 2. Dose reduction 3. Temporary discontinuation of treatment. 4. Definitive Treatment discontinuation). Measuring time: 2 years 8. Outcome of the AE (1. reversible effect. Measuring time: 2 years 2. Effect 3. Death 4. Irreversible loss of patient monitoring). Measuring time: 2 years 9. Treatment (Name and dosage of the treatment received). Measuring time: 2 years 10. Batch (Number of Nimotuzumab bulb): Measuring time: 2 years 11. Physical exam (Vital signs, Height, Weight, ECOG). Measuring time: 2 years 12. Laboratory tests (Hematology: Hemoglobin, Hematocrit, White blood cell count with differential, Platelet count; Biochemistry: Glutamic-oxaloacetic transaminase / aspartate aminotransferase (GOT/AST), and glutamic-pyruvic transaminase/alanine aminotransferase (GPT/ALT), Bilirubin, Alkaline Phosphatase, Glycemia, Total protein, Creatinine, Normal urine (OR))). Measuring time: 2 years Effectiveness 1. Overall survival-OS (Time from the date of inclusion of each patient until the date of death or the last date that has news of the patient. Measuring time: 2 years 2. Progression-free survival-PFS (Time from the date of inclusion of each patient until the date of determination of the progression, death or the last date that the patient has the news). Measuring time: 2 years 3. Quality of life (Questionnaire EORTC QLQ-C30 | — |
Countries
Cuba
Contacts
Public ContactYaimarelis Saumell Napoles
Center of Molecular Immunology
Outcome results
None listed