Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000003279
Ethics application status
Approved
Date submitted
8/10/2008
Date registered
6/01/2009
Date last updated
6/01/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
Cisplatin and oral vinorelbine chemotherapy along with radiation for treatment of locally advanced lung cancer
Scientific title
A phase II trial evaluating progression free survival with cisplatin and oral vinorelbine plus radiation for Stage III Non Small Cell Lung Cancer
Universal Trial Number (UTN)
Trial acronym
CoVERT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stage III Non Small Cell Lung Cancer 3808 0
Condition category
Condition code
Cancer 3990 3990 0 0
Lung - Non small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Oral vinorelbine 50 mg/m2 day 1,8 along with intravenous cisplatin at dose of 50 mg/m2 day 1,8 every 3 weeks for 2 cycles along with 60 Gy radiation treatment at the rate of 2 Gy per fraction. All the treatment is given simultaneously.
Intervention code [1] 3528 0
Treatment: Drugs
Comparator / control treatment
None
Control group
Uncontrolled

Outcomes
Primary outcome [1] 4894 0
Progression free survival using computerised tomography (CT) scan
Timepoint [1] 4894 0
2 monthly follow up till evidence of disease progression or death.
Secondary outcome [1] 8265 0
response rate using CT scan
Timepoint [1] 8265 0
4 weeks after completion of treatment

Eligibility
Key inclusion criteria
Histologically or cytologically (fine needle aspiration) proven non-small cell lung cancer
Performance status 0-1
Forced expiratory volume (FEV1) >1 Ltr
Adequate hematology and biochemistry
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Neuropathy > Grade 1
Uncontrolled medical disorder
Malabsorption syndrome
Women if pregnant or breast-feeding

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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/08/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 3989 0
Commercial sector/Industry
Name [1] 3989 0
Pierre Fabre Medicament Pvt Ltd
Country [1] 3989 0
Australia
Primary sponsor type
Hospital
Name
Royal Adelaide Hospital
Address
North Terrace
Adelaide, SA 5000
Country
Australia
Secondary sponsor category [1] 3579 0
None
Name [1] 3579 0
Address [1] 3579 0
Country [1] 3579 0
Secondary sponsor category [2] 3725 0
None
Name [2] 3725 0
Address [2] 3725 0
Country [2] 3725 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6064 0
Royal Adelaide Hospital
Ethics committee address [1] 6064 0
Ethics committee country [1] 6064 0
Australia
Date submitted for ethics approval [1] 6064 0
Approval date [1] 6064 0
Ethics approval number [1] 6064 0

Summary
Brief summary
The study is looking at efficacy of combination of oral vinorelbine and cisplatin with radiation for locally advanced lung cancer. The combination is unique as it combine oral with intravenous treatment.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29021 0
Address 29021 0
Country 29021 0
Phone 29021 0
Fax 29021 0
Email 29021 0
Contact person for public queries
Name 12178 0
Nimit Singhal
Address 12178 0
Cancer Centre, Royal Adelaide Hospital, North Terrace, Adelaide, SA 5000
Country 12178 0
Australia
Phone 12178 0
+61 8 8224398
Fax 12178 0
Email 12178 0
nimit.singhal@health.sa.gov.au
Contact person for scientific queries
Name 3106 0
Nimit Singhal
Address 3106 0
Cancer Centre, Royal Adelaide Hospital, North Terrace
Adelaide, SA 5000
Country 3106 0
Australia
Phone 3106 0
+61 8 88224398
Fax 3106 0
Email 3106 0
nimit.singhal@health.sa.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.