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Trial registered on ANZCTR
Registration number
ACTRN12610000046000
Ethics application status
Approved
Date submitted
6/01/2010
Date registered
18/01/2010
Date last updated
18/01/2010
Type of registration
Retrospectively registered
Titles & IDs
Public title
Treatment of Lung Adenocarcinoma by Liposomal Cisplatin
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Scientific title
Comparison of effectiveness of Liposomal Cisplatin combined with Paclitaxel versus Cisplatin combined with Paclitaxel in patients with adenocarcinoma and undifferentiated carcinoma of the lungs.
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Secondary ID [1]
1233
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No other registration.
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Universal Trial Number (UTN)
None.
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Inoperable lung cancer
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Condition category
Condition code
Cancer
256642
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Lung - Non small cell
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Liposomal Cisplatin 200 mg/m2 in 1 lt of dextrose for 8 hours infusion combined with Paclitaxel 135 mg/m2 infusion for 3 hours every 2 weeks for 9 cycles. Treatment was administered once every 2 weeks (on day 1 repeated on day 15th, then 29th and so on for 9 cycles).
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Intervention code [1]
255759
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Treatment: Drugs
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Comparator / control treatment
Cisplatin 75 mg/m2 and 250 cc normal seline combined with Paclitaxel 135 mg/m2 for 3 hours infusion. Hydration with 1 lt normal saline and 1 lt electrolyte. The cytotoxic drygs were given once every 2 weeks at a lower dose than that given every 3 weeks. The every 3 weeks treatment dosis is 100 mg/m2 for Cisplatin and 175 mg/m2 for Paclitaxel. (These doses have been used in other studies of the past. It is not a third arm of the present study). Both agents were given every time for 9 courses unless disease progression was observed before treatment courses were completed.
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Control group
Active
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Outcomes
Primary outcome [1]
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Response rate. Assessed mainly by computerized tomography chest x-ray and occasionally magnetic reasonance tomography.
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Assessment method [1]
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Timepoint [1]
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2 years. The 2 years duration was the time period for patients recruitement and 6 months follow-up after the last patient's recruitement (post-treatment).
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Secondary outcome [1]
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Progression Free Survival (Pfs) and survival. The time from treatment start until the date of disease progression. It was mainly assessed by computerized tomography and also chest x-ray and clinical evaluation. Survival was assessed from treatment start to death or to the time study was closed.
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Assessment method [1]
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Timepoint [1]
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2 years. The 2 years duration was the time period for patients recruitement and 6 months follow-up after the last patient's recruitement (post-treatment).
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Eligibility
Key inclusion criteria
Histologically or cytologically confirmed Non-Small-Cell lung cancer, treatment naive, bidimentionally measurable disease , performance status 0-2, expected survival = 12 weeks.
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Minimum age
18
Years
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Maximum age
82
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Second primary malignancy, central nervous system metastasis.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients are randomly assigned into two treatment arms. Randomisation was performed according to the method of random permuted blocks within strata. Dynamic balancing by center is to be also performed. The Kaplan-Meier method was used to estimate survival distribution and the log-rank for the comparison of the treatment arms. The allocation was based on the stage of disease and was done by a statistician. Allocation was concealed since it was done by central randomisation by phone.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
1/09/2007
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
150
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Accrual to date
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Final
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Recruitment outside Australia
Country [1]
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Greece
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State/province [1]
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Attica
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Funding & Sponsors
Funding source category [1]
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Self funded/Unfunded
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Name [1]
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George P. Stathopoulos
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Address [1]
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Semitelou 2A, Athens, 115 28, Attica.
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Country [1]
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Greece
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Primary sponsor type
Individual
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Name
George P. Stathopoulos
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Address
Semitelou 2A, Athens, 115 28, Attica.
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Country
Greece
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Errikos Dunant Hospital and Hospital of Thoracic Disorders Ethical Committees
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Ethics committee address [1]
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Mesogeion 107, Athens, 115 26, Attica.
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Ethics committee country [1]
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Greece
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Date submitted for ethics approval [1]
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01/06/2007
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Approval date [1]
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01/07/2007
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Ethics approval number [1]
258338
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04
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Summary
Brief summary
Liposomal Cisplatin has shown to be less toxic than Cisplatin. Dimished side effects such as nephrotoxicity and GI tract toxicity. The present study was to detect mainly the response rate between the two drugs combined with Paclitaxel.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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George P. Stathopoulos
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Address
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Semitelou 2A, Athens, 115 28, Attica.
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Country
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Greece
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Phone
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30 1 693 7075160
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Fax
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00 30 210 7251736
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Email
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dr-gps@ath.forthnet.gr
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Contact person for scientific queries
Name
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George P. Stathopoulos
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Address
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Semitelou 2A, Athens, 115 28, Attica.
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Country
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Greece
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Phone
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30 1 693 7075160
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Fax
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0030 210 7251736
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Email
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dr-gps@ath.forthnet.gr
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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