Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000165583
Ethics application status
Approved
Date submitted
27/04/2006
Date registered
9/05/2006
Date last updated
9/05/2006
Type of registration
Retrospectively registered

Titles & IDs
Public title
A randomised clinical trial of two types of chronic indwelling venous access devices used for the for the delivery of chemotherapy to patients with non-haematological malignancy - peripherally inserted central venous catheter (PICC) versus subcutaneoulsy implanted port catheters (PORT)
Scientific title
A randomised clinical trial of two types of chronic indwelling venous access devices used for the for the delivery of chemotherapy to patients with non-haematological malignancy - peripherally inserted central venous catheter (PICC) versus subcutaneoulsy implanted port catheters (PORT)
Universal Trial Number (UTN)
Trial acronym
PICC Versus PORT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non haematalogic patients requiring chronic indwelling venous access device for chemotherapy 1138 0
Condition category
Condition code
Other 1218 1218 0 0

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparison of peripherally inserted central venous catheter (PICC) versus subcutaneoulsy implanted port catheters (PORT) Both these Central venous catheters (CVC) can be removed at the end of chemotherapy. Chemotherapy duration can range from 6 weeks to 6 months.
Intervention code [1] 803 0
None
Comparator / control treatment
Control group
Active

Outcomes
Primary outcome [1] 1650 0
Central Venous Catheter (CVC) related serious complications as defined below:
-any complication that requires the removal of the CVC
-catheter related thrombosis requiring thrombolytic or anticoagulant therapy
-catheter related infection requiring systemic antibiotics
-pneumothorax
-accidental complete dislodgment of the CVC
-blockage or disruption of the CVC that renders the catheter useless
-other complications perceived as serious by the treating physician
-failure of insertion of CVC for whatever reason
Timepoint [1] 1650 0
Complications will be assessed for the following time periods:
0 - 6 weeks after CVC insertion.
6 - 12 weeks after CVC insertion.
Overall period of CVC requirement for chemotherapy administration.

(Failure of insertion of CVC for whatever reason will be recorded as a serious complication occurring on day 1.)
Primary outcome [2] 1651 0
A comparison of all serious complications between the two arms will be performed.
Timepoint [2] 1651 0
Complications will be assessed for the following time periods:
0 - 6 weeks after CVC insertion.
6 - 12 weeks after CVC insertion.
Overall period of CVC requirement for chemotherapy administration.
Primary outcome [3] 1652 0
A comparison of the incidence of thrombosis between the 2 arms will be performed.
Timepoint [3] 1652 0
Complications will be assessed for the following time periods:
0 - 6 weeks after CVC insertion.
6 - 12 weeks after CVC insertion.
Overall period of CVC requirement for chemotherapy administration.
Primary outcome [4] 1653 0
A comparison of the incidence of infection (requiring antibiotic treatment) will be performed.
Timepoint [4] 1653 0
Complications will be assessed for the following time periods:
0 - 6 weeks after CVC insertion.
6 - 12 weeks after CVC insertion.
Overall period of CVC requirement for chemotherapy administration.
Secondary outcome [1] 2948 0
All other CVC related events.
1.Minor complications
The following events will be classified as minor complications:
- minor superficial inflammation treated conservatively or with topical measures
- pain over the insertion site that is controlled with analgesics
- partial dislodgment of the CVC
- blockage of one or more CVC lumen that does not require anticoagulant therapy or render the CVC useless
- other CVC-related events considered non-serious by the treating physician
Timepoint [1] 2948 0
Time points are at 0-6 weeks, 6-12 weeks after CVC insertion, and overall duration of chemotherapy

Eligibility
Key inclusion criteria
1.All patients with cancer (excluding leukaemia and myeloma) who require chemotherapy administration through a CVC2.Minimum anticipated duration of CVC directed therapy is 1 month (30 days).3. Patients should have a projected life expectancy of at least 3 months5.Written informed consent.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1.Inability to provide informed consent2.Any contraindication to insertion of either PICC or PORT catheter3.Anticipated inability to follow-up patient for CVC care4.Previous participation in this trial (ie the same patient cannot be entered twice into the trial in the event that the original CVC is removed and another CVC is to be inserted).5.Patient to receive high dose chemotherapy and stem cell or bone marrow transplantation.

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)
concealed envelope randomisations
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
randomised controlled trial, using a computer generated randomisation table which has been placed in opaque envelopes by a non research team individual
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/12/2004
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1329 0
Hospital
Name [1] 1329 0
Flinders Medical Centre
Country [1] 1329 0
Australia
Primary sponsor type
Hospital
Name
Flinders Medical Centre
Address
Country
Australia
Secondary sponsor category [1] 1173 0
None
Name [1] 1173 0
Nil
Address [1] 1173 0
Country [1] 1173 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2676 0
Flinders Medical Centre
Ethics committee address [1] 2676 0
Ethics committee country [1] 2676 0
Australia
Date submitted for ethics approval [1] 2676 0
Approval date [1] 2676 0
Ethics approval number [1] 2676 0
Ethics committee name [2] 2677 0
Monash Medical Centre
Ethics committee address [2] 2677 0
Ethics committee country [2] 2677 0
Australia
Date submitted for ethics approval [2] 2677 0
Approval date [2] 2677 0
Ethics approval number [2] 2677 0
Ethics committee name [3] 2678 0
Queen Elizabeth Hospital
Ethics committee address [3] 2678 0
Ethics committee country [3] 2678 0
Australia
Date submitted for ethics approval [3] 2678 0
Approval date [3] 2678 0
Ethics approval number [3] 2678 0

Summary
Brief summary
Patients receiving intravenous chemotherapy may require a central venous catheter (CVC) to enable effective delivery of the cytotoxic treatment. This is usually because of either difficult peripheral venous access or prolonged infusional chemotherapy schedules. This study is a randomised clinical trial comparing two types of CVC, the peripherally inserted central venous catheter (PICC) and the subcutaneously implanted port catheter (PORT catheter). The primary end point is CVC related complications.

Background

The last three decades have seen an increase in the use of chronic indwelling central venous catheter devices (CVC) in the setting of cancer treatment. CVCs enable effective delivery of chemotherapy into the venous system, and are particularly useful when peripheral venous access is otherwise difficult or when prolonged infusions of chemotherapy are required. The CVC also facilitates outpatient based therapy.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35358 0
Address 35358 0
Country 35358 0
Phone 35358 0
Fax 35358 0
Email 35358 0
Contact person for public queries
Name 9992 0
Ms Alison Richards
Address 9992 0
Department of Medical Oncology
Flinders Medical Centre
Bedford Park SA 5042
Country 9992 0
Australia
Phone 9992 0
+61 8 8204 8997
Fax 9992 0
+61 8 8204 4997
Email 9992 0
[email protected]
Contact person for scientific queries
Name 920 0
Dr Chris Karapetis
Address 920 0
Clinical Trials Unit
Department of Medical Oncology
Flinders Medical Centre
Bedford Park SA 5042
Country 920 0
Australia
Phone 920 0
+61 8204 8997
Fax 920 0
+61 8 8 204 4997
Email 920 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
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