Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000043437
Ethics application status
Approved
Date submitted
2/09/2005
Date registered
12/01/2007
Date last updated
28/02/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
Weekly Carboplatin and Taxol with concurrent radiotherapy for locally advanced non small cell lung : Predictive factors for completion of treatment.
Scientific title
Weekly Carboplatin and Taxol with concurrent radiotherapy for locally advanced non small cell lung cancer:Predictive factors for completion of treatment.
Universal Trial Number (UTN)
Trial acronym
CARBOTAX
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non Small Cell Lung Cancer (NSCLC) 1536 0
Condition category
Condition code
Cancer 1633 1633 0 0
Lung - Non small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
6 cycles of weekly carboplatin and paclitaxel , concurrent radiotherapy and either induction or consolidation carboplatin and paclitaxel (2 x 3 weekly cycles). This is a complex protocol with dosages changing according to whether the patient is receiving concurrent treatment it is not practical to give the doses of every drug at every time. The mode of administration for each drug is intravenous. There is no control group.
Intervention code [1] 344 0
Treatment: Drugs
Comparator / control treatment
There is no control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 2256 0
Proportion of patients completing treatment
Timepoint [1] 2256 0
Measured at the end of protocol, which is at the end of the induction/consolidation and concurrent treatment the exact length this will be will depend upon the gap between the treatments and associated treatment delays. The date of assessment for the primary outcome is not fixed but the "timepoint" will depnd upon treatment duration for each patient
Secondary outcome [1] 3930 0
Median overall and progression free survival.
Timepoint [1] 3930 0
Measured at 3 monthly follow ups until death.

Eligibility
Key inclusion criteria
Stage IIIA/B histologically proven NSCLC. ECOG Performance Status 0 or1. Weight loss < 10% compared to original (pre-diagnosis) weight. FeV1 (Forced Expiratory volume 1 second) > 1.0L. Adequate hematological and biochemical reserve.
Minimum age
17 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Glomerular Filtration Rate (GFR) < 50ml/min (Cockroft-Gault formula). Prior chemotherapy or irradiation. Prior diagnosis of invasive cancer within the last 2 years. Symptomatic sensory or motor neuropathy. Contraindications to steroids. Pregnant or breastfeeding mothers. Intercurrent medical illnesses precluding combined modality therapy (except with clinician's authorisation).

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Date of first participant enrolment
Anticipated
1/01/2004
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
45
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1780 0
Commercial sector/Industry
Name [1] 1780 0
Bristol Myers Squibb
Country [1] 1780 0
Australia
Primary sponsor type
Government body
Name
South Eastern Illawarra Area Health service
Address
SESIAHS
c/o St George Hospital Gray St Kogarah 2217
Country
Australia
Secondary sponsor category [1] 1584 0
None
Name [1] 1584 0
Nil
Address [1] 1584 0
Country [1] 1584 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3335 0
st george
Ethics committee address [1] 3335 0
Ethics committee country [1] 3335 0
Australia
Date submitted for ethics approval [1] 3335 0
Approval date [1] 3335 0
10/10/2003
Ethics approval number [1] 3335 0
03-152
Ethics committee name [2] 3336 0
Bankstown
Ethics committee address [2] 3336 0
Ethics committee country [2] 3336 0
Australia
Date submitted for ethics approval [2] 3336 0
Approval date [2] 3336 0
04/02/2004
Ethics approval number [2] 3336 0
03/153
Ethics committee name [3] 3337 0
Wollongong
Ethics committee address [3] 3337 0
Ethics committee country [3] 3337 0
Australia
Date submitted for ethics approval [3] 3337 0
Approval date [3] 3337 0
01/08/2005
Ethics approval number [3] 3337 0
Ethics committee name [4] 3338 0
Westmead
Ethics committee address [4] 3338 0
Ethics committee country [4] 3338 0
Australia
Date submitted for ethics approval [4] 3338 0
Approval date [4] 3338 0
03/11/2005
Ethics approval number [4] 3338 0
Ethics committee name [5] 3339 0
POW
Ethics committee address [5] 3339 0
Ethics committee country [5] 3339 0
Australia
Date submitted for ethics approval [5] 3339 0
Approval date [5] 3339 0
04/05/2005
Ethics approval number [5] 3339 0
03/241
Ethics committee name [6] 3340 0
RNSH
Ethics committee address [6] 3340 0
Ethics committee country [6] 3340 0
Australia
Date submitted for ethics approval [6] 3340 0
Approval date [6] 3340 0
13/09/2004
Ethics approval number [6] 3340 0
0403-073M

Summary
Brief summary
This trial aims to determine the effiacy and toxicity of a standard treatment approach to locally advanced NSCLC in NSW and to examine potential predictors of treatment tolerability.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35838 0
Address 35838 0
Country 35838 0
Phone 35838 0
Fax 35838 0
Email 35838 0
Contact person for public queries
Name 9533 0
Antoinette Fontela
Address 9533 0
Clinical Trials Unit
St George Hospital
Kogarah NSW 2217
Country 9533 0
Australia
Phone 9533 0
+61 2 93501935
Fax 9533 0
+61 2 93502960
Email 9533 0
Antoinette.Fontela@sesiahs.health.nsw.gov.au
Contact person for scientific queries
Name 461 0
Matthew Links
Address 461 0
Clinical Trials Unit
St George Hospital
Kogarah NSW 2217
Country 461 0
Australia
Phone 461 0
+61 2 93501935
Fax 461 0
+61 2 93502960
Email 461 0
Matthew.Links@sesiahs.health.nsw.gov.au

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.