Non-Small Cell Lung Cancer
Conditions
Sponsors
Thoracale Oncologie Groep Antwerpen
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •-Cytological or histologically proven NSCLC -Unresectable stage III NSCLC (with the exception of T4 malignant pleural or pericardial effusion and sulcus superior tumors) -Karnofsky Performance Score 70-100 -Age = 18 yrs -Weight loss 3 months -Presence of at least one measurable lesion (using RECIST criteria) 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) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: -Previous chemo- or radiotherapy for NSCLC -Presence of distant metastasis or a malignant pleural or pericardial effusion. -Second active primary malignancy -Serious concomittant medical disease or psychiatric disease that, in the opinion of the investigator, would compromise the safety of the patient or compromise the patient's ability to complete the study. -Inability to interrupt aspirin or other non-steroidal anti-inflammatory agents for a 5-day period -Known interstitial lung disease -Known auto-immune systemic disease with potential involvement of the lungs -Concomittant use of amiodarone
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The aim of the study is to evaluate the efficacy (response rate) of pemetrexed combined with cisplatin combined with radiotherapy and concurrent pemetrexed for unresectable stage III NSCLC.;Secondary Objective: Toxicity Time to progression Two-year and overall survival;Primary end point(s): Overall Respnse rate | — |
Countries
Belgium
Outcome results
None listed