Malignant neoplasm of lung and brochous. 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
Conditions
Interventions
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: C
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.
Sponsors
Investigator
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival. Timepoint: From date of registration to disease progression. Method of measurement: Time between date of registration to disease progression. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactAdnan Khosravi
National Institute of Tubercolusis and Lung Disease(NRITLD)
Outcome results
None listed