Trial Review

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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
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.
Secondary ID [1] 1233 0
No other registration.
Universal Trial Number (UTN)
None.
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Inoperable lung cancer 256474 0
Condition category
Condition code
Cancer 256642 256642 0 0
Lung - Non small cell

Intervention/exposure
Study type
Interventional
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).
Intervention code [1] 255759 0
Treatment: Drugs
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.
Control group
Active

Outcomes
Primary outcome [1] 257536 0
Response rate. Assessed mainly by computerized tomography chest x-ray and occasionally magnetic reasonance tomography.
Timepoint [1] 257536 0
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).
Secondary outcome [1] 262771 0
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.
Timepoint [1] 262771 0
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).

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.
Minimum age
18 Years
Maximum age
82 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Second primary malignancy, central nervous system metastasis.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
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.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/09/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment outside Australia
Country [1] 2386 0
Greece
State/province [1] 2386 0
Attica

Funding & Sponsors
Funding source category [1] 256244 0
Self funded/Unfunded
Name [1] 256244 0
George P. Stathopoulos
Country [1] 256244 0
Greece
Primary sponsor type
Individual
Name
George P. Stathopoulos
Address
Semitelou 2A, Athens, 115 28, Attica.
Country
Greece
Secondary sponsor category [1] 251574 0
None
Name [1] 251574 0
Address [1] 251574 0
Country [1] 251574 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258338 0
Errikos Dunant Hospital and Hospital of Thoracic Disorders Ethical Committees
Ethics committee address [1] 258338 0
Mesogeion 107, Athens, 115 26, Attica.
Ethics committee country [1] 258338 0
Greece
Date submitted for ethics approval [1] 258338 0
01/06/2007
Approval date [1] 258338 0
01/07/2007
Ethics approval number [1] 258338 0
04

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30663 0
Address 30663 0
Country 30663 0
Phone 30663 0
Fax 30663 0
Email 30663 0
Contact person for public queries
Name 13910 0
George P. Stathopoulos
Address 13910 0
Semitelou 2A, Athens, 115 28, Attica.
Country 13910 0
Greece
Phone 13910 0
30 1 693 7075160
Fax 13910 0
00 30 210 7251736
Email 13910 0
[email protected]
Contact person for scientific queries
Name 4838 0
George P. Stathopoulos
Address 4838 0
Semitelou 2A, Athens, 115 28, Attica.
Country 4838 0
Greece
Phone 4838 0
30 1 693 7075160
Fax 4838 0
0030 210 7251736
Email 4838 0
[email protected]

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.