Non-small cell lung cancer
Conditions
Interventions
Trade Name: Gemzar
Product Name: Gemcitabina
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: Gemcitabina
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type
Sponsors
Spanish Lung Cancer Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Subjects with Stage IIIA NSCLC (any subtype), confirmed by histological or cytological diagnosis - Clinically measurable lesions amenable to curative surgical resection - No prior tumoral therapy - Men or women between 18 and 65 years old - ECOG status of 0-1 - Adequate baseline hematology and adequate liver and renal function Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Subjects with Stage I-II and Stage IIIB-IV disease - Concurrent administration of any other tumoral therapy, including radiotherapy, cytotoxic chemotherapy, inmunotherapy, molecualr target therapy - Treatment with a investigator drug in the last 30 days before the inclusion period - Non-controlled diabetes mellitus - Previous significant neurological or mental disorder, such a epilepsy or madness - Another primary maligny neoplasie detected during the inclusion period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the feasibility of administering neoadyuvant dose-dense GCb chemotherapy with pegfilgrastim support at planned dose and on time;Secondary Objective: - To evaluate the proportion of the patients down-staged after pre-operative chemotherapy - To evaluate the overall clinical response rate - To determinate the pathological complete response rate - To evaluate the safety of neo-adyuvante chemotherapy with GCb - To evaluate disease free survival ;Primary end point(s): Feasibility of adminstering neoadyuvant dose-dense GCb chemotherapy with pegfilgrastim support at planned dose and on time | — |
Countries
Spain
Outcome results
None listed