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IRCT2015060822610N1 IRCT 2016-08-17 Investigator Meinetenance chemotherapy in lung cancer Randomized Phase II study of Vinorelbine Maintenance therapy vs Best Supportive Care in Advanced Non Small Cell Lung Cancer 2015-06-20 anticipated 100 Complete https://irct.ir/trial/19477 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: randimization will be performed by using random number tables. 2 Malignant neoplasm of lung and brochous. Intervention 1: Intervention group:Switch maintenance therapy with Novelbine (Vinorelbine tartrate, Pierre Fabre Pharmaceutical, Inc.) (25mg/m2, day 1,15) up to disease progression. Intervention 2: Control group: Best supoortive care untill disease progression.
public Adnan Khosravi
Dar Abad, Shaheed Bahonar Ave,
Tehran Iran (Islamic Republic of) 19569-44413 +98 21 2610 9946 adkhosravi@yahoo.comadkhosravi@sbmu.ac.ir National Institute of Tubercolusis and Lung Disease(NRITLD) scientific Adnan Khosravi
Dar Abad, Shaheed Bahonar Ave
Tehran Iran (Islamic Republic of) 19569-44413 +98 21 2610 9946 adkhosravi@sbmu.ac.ir Tobacco Prevention and Control Research Center, National Research Institute of Tuberculosis and Lung Iran (Islamic Republic of) Inclusion criteria was: NSCLC pathology, age of 18 years or older, eastern cooperative oncology group (ECOG) performance statutes (PS) of 0-2, no pervious history of any systemic chemotherapy , advanced stage according AJCC, 7th editionat least one unidimensionally measurable or assessable disease, adequate bone marrow reserve, serum creatinine less than or equal to 1.5 mg/dL or a calculated creatinine clearance greater than or equal to 60 mL/min, bilirubin level less than or equal to 2.0 mg/dL, AST less than or equal to twice the institutional upper limits of normal and or less than or equal to four times the institutional upper limits of normal if the patient had liver metastasis. Exclusion criteria was: administration of systemic chemotherapy, PS 3 and 4 , small cell lung cancer pathology,metastatic from other site,significant or uncontrolled cardiac, metabolic or infectious diseases and symptomatic brain metastasis. 18 years no limit Both C 34 Malignant neoplasm of bronchus and lung including: main bronchus, upper lobe bronchus , Middle lobe bronchus, Lower lobe, bronchus or Bronchus or lung, unspecified.code:C34 Treatment - Drugs Treatment - Drugs Intervention group:Switch maintenance therapy with Novelbine (Vinorelbine tartrate, Pierre Fabre Pharmaceutical, Inc.) (25mg/m2, day 1,15) up to disease progression. Control group: Best supoortive care untill disease progression. Progression free survival. Timepoint: From date of registration to disease progression. Method of measurement: Time between date of registration to disease progression. Overall survival. Timepoint: From date of registration to disease progression. Method of measurement: Time between date of registration to disease progression. Common Toxicity Critria. Timepoint: Before each chemotherapy course. Method of measurement: according to CTC version 3. Investigator Approved 2014-08-20 ethics and scientific committees of National Institute of Tubercolusis and Lung Disease(NRITLD) Dar Abad, Shaheed Bahonar Ave, Tehran Iran (Islamic Republic of)