In this single blind, prospective, single institute , phase 2 and randomized trial, 100 patients with non small cell lung cancer (NSCLC)pathology, age >18 years, eastern cooperative oncology group (ECOG) performance statutes (PS) of 0-2, no pervious history of systemic chemotherapy and advanced stage (IIIB and IV) will be treated up to 6 cycles with Gemcitabine 1250 mg/m2 (day 1 and 8) plus Carboplatinarea under the concentration-time curve (AUC) 5 (day 1) every 3 weeks. Patients without progressive disease after first-line chemotherapy will be randomly assigned to receive switch maintenance with Vinorelbine (25mg/m2, day 1,15) or best supportive care until disease progression. Primary end point is progression free survival (PFS).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015060822610N1
Registration date:2016-08-17, 1395/05/27
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-08-17, 1395/05/27
Registrant information
Name
Adnan khosravi
Name of organization / entity
National institute of Tuberculosis and Lung Disease(NRITLD)
Country
Iran (Islamic Republic of)
Phone
+98 21 2610 9946
Email address
adkhosravi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2015-06-20, 1394/03/30
Expected recruitment end date
2017-06-20, 1396/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Randomized Phase II study of Vinorelbine Maintenance therapy vs Best Supportive Care in Advanced Non Small Cell Lung Cancer
Public title
Meinetenance chemotherapy in lung cancer
Purpose
Treatment
Inclusion/Exclusion 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.
Age
From 18 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
randimization will be performed by using random number tables.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
ethics and scientific committees of National Institute of Tubercolusis and Lung Disease(NRITLD)
Street address
Dar Abad, Shaheed Bahonar Ave,
City
Tehran
Postal code
Approval date
2014-08-20, 1393/05/29
Ethics committee reference number
پ/25/29/34562
Health conditions studied
1
Description of health condition studied
Malignant neoplasm of lung and brochous
ICD-10 code
C 34
ICD-10 code description
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
Primary outcomes
1
Description
Progression free survival
Timepoint
From date of registration to disease progression
Method of measurement
Time between date of registration to disease progression
Secondary outcomes
1
Description
Overall survival
Timepoint
From date of registration to disease progression
Method of measurement
Time between date of registration to disease progression
2
Description
Common Toxicity Critria
Timepoint
Before each chemotherapy course
Method of measurement
according to CTC version 3
Intervention groups
1
Description
Intervention group:Switch maintenance therapy with Novelbine (Vinorelbine tartrate, Pierre Fabre Pharmaceutical, Inc.) (25mg/m2, day 1,15) up to disease progression.
Category
Treatment - Drugs
2
Description
Control group: Best supoortive care untill disease progression.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
National Institute of Tuberculosis and Lung Disease (NRITLD), Masih Daneshvari Hospital
Full name of responsible person
Adnan Khosravi
Street address
DarAbad, Shahid Bahonar Ave.,
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Investigator
Full name of responsible person
Adnan Khosravi
Street address
Dar Abad, National Institute of Tuberculosis and Lung Disease
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Investigator
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
National Institute of Tubercolusis and Lung Disease(NRITLD)
Full name of responsible person
Adnan Khosravi
Position
M.D, Associated professor of medical oncology/ Head of NRITLD oncology department
Other areas of specialty/work
Street address
Dar Abad, Shaheed Bahonar Ave,
City
Tehran
Postal code
19569-44413
Phone
+98 21 2610 9946
Fax
Email
adkhosravi@yahoo.comadkhosravi@sbmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tobacco Prevention and Control Research Center, National Research Institute of Tuberculosis and Lung
Full name of responsible person
Adnan Khosravi
Position
M.D
Other areas of specialty/work
Street address
Dar Abad, Shaheed Bahonar Ave
City
Tehran
Postal code
19569-44413
Phone
+98 21 2610 9946
Fax
+98 21 2610 9946
Email
adkhosravi@sbmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
National Research Institute of Tubercolusis and Lung Disease
Full name of responsible person
Adnan Khosravi
Position
Head of Hematology and oncology department/ M.D
Other areas of specialty/work
Street address
Dar Abad, Shahid Bahonar Ave
City
Tehran
Postal code
19569-44413
Phone
+98 21 2610 9946
Fax
+98 21 2610 9946
Email
adkhosravi@sbmu.ac.iradkhosravi@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)