The second-line treatment in advanced NSCLC has been currently proved effective in prolonging overall survival and improving quality of life. Both pemetrexed and erlotinib have been approved for second-line treatment of NSCLC . Erlotinib is a valuable option for the treatment of advanced NSCLC, especially for elderly patients, due to convenience of administration and safety profile. The role of comprehensive geriatric assessment in treatment efficacy and tolerance is an area of investigation.
This trial will compare the efficacy of pemetrexed versus erlotinib in pretreated patients with advanced NSCLC.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
320
Erlotinib at the dose of 150 mg orally once a day continually until progression
Pemetrexed at the dose of 500mg/m2 IV infusion every 3 weeks for 6 consecutive cycles
University General Hospital of Alexandroupolis, Dep of Medical Oncology
Alexandroupoli, Greece
401 Military Hospital, Medical Oncology Unit
Athens, Greece
Air Forces Military Hospital, Dep of Medical Oncology
Athens, Greece
Time to Tumor Progression
Time frame: 1 year TTP
Overall response rate
Time frame: Objective responses confirmed by CT or MRI (on 3rd and 6th cycle)
Overall survival between the two treatment arms
Time frame: 1 year OS
Quality of life assessment
Time frame: Assessment every two cycles
Toxicity profile between the two treatment arms
Time frame: Toxicity assessment on each chemotherapy cycles
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
IASO General Hospital of Athens, 1st Department of Medical Oncology
Athens, Greece
Laikon General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine
Athens, Greece
Sismanogleio General Hospital, 1st, 2nd Department of Pulmonary Diseases
Athens, Greece
Sotiria General Hospital, 1st, 3rd, 8th Dep of Pulmonary Diseases
Athens, Greece
Metaxa's Anticancer Hospital of Piraeus,1st Dep of Medical Oncology
Piraeus, Greece
Theagenion Anticancer Hospital of Thessaloniki
Thessaloniki, Greece