Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000359639
Ethics application status
Approved
Date submitted
9/09/2005
Date registered
9/09/2005
Date last updated
21/05/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Randomised Phase II trial of de Gramont schedule 5-fluorouracil and leucovorin plus irinotecan versus single agent irinotecan in patients with previously treated metastatic colorectal cancer (DaVINCI)
Scientific title
Randomised Phase II trial of de Gramont schedule 5-fluorouracil and leucovorin plus irinotecan versus single agent irinotecan in patients with previously treated metastatic colorectal cancer (DaVINCI)
Secondary ID [1] 150 0
Australasian Gastro-Intestinal Trials Group: AG0103CR
Secondary ID [2] 151 0
National Clinical Trials Registry: 578
Universal Trial Number (UTN)
Trial acronym
DaVINCI
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metastatic colorectal cancer 454 0
Condition category
Condition code
Cancer 530 530 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Irinotecan versus irinotecan + 5-FU/leucovorin.
Duration: Until patients progress
Intervention code [1] 424 0
Treatment: Drugs
Comparator / control treatment
For the purposes of this study, the "Standard" therapy will be considered as single agent Irinotecan which will be compared to the combination of irinotecan/5-FU/LV
Control group
Active

Outcomes
Primary outcome [1] 610 0
Rates of Grade 3/4 diarrhoea
Timepoint [1] 610 0
Every 2 weeks (combination arm) and Every 3 weeks (single agent arm) using the CTC AE Version 3.0 scale.
Secondary outcome [1] 1275 0
Rates of other Grade 3/4 toxicities
Timepoint [1] 1275 0
Every 2 weeks (combination arm) and Every 3 weeks (single agent arm) using the CTC AE Version 3.0 scale.
Secondary outcome [2] 1276 0
Overall survival measured by patient status updates during follow-up clinic visits.
Timepoint [2] 1276 0
At Baseline and 6 weekly for a minimum of 12 weeks
Secondary outcome [3] 1277 0
Quality of life measured by the QLQ-C30 questionnaire.
Timepoint [3] 1277 0
Baseline and then 6 weekly
Secondary outcome [4] 276689 0
Progression Free Survival assessed by CT scans using RECIST Version 1.0.
Timepoint [4] 276689 0
Baseline and then 6 weekly
Secondary outcome [5] 276690 0
Overall Survival measured by patient status updates during follow-up clinic visits.
Timepoint [5] 276690 0
Baseline and then 6 weekly

Eligibility
Key inclusion criteria
(1) Metastatic or locally advanced colon or rectal cancer not curable by surgery or other methods.
(2) At least one lesion evaluable for response by RECIST criteria.
(3) Age = 18 years.
(4) Life expectancy of at least 12 weeks.
(5) ECOG performance status 0-2.
(6) Confirmed progression after one prior chemotherapy regimen for advanced disease or relapse within 6 months of receiving prior adjuvant chemotherapy.
(7) Normal haematological tests: haemoglobin >10 g/dL, WBC >4.0 x 109/L, neutrophils > 1.5 x 109/L, platelets >100 x 109/L
(8) Normal renal function tests, documented as serum creatinine ? 2.0 x IULN
(9) Adequate hepatic function. Bilirubin must be ? 1.5 x IULN for all patients
(10) Patients must be geographically accessible and physically capable of completing study investigations as required
(11) 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) Serious infection or other intercurrent illness which will prevent adequate assessment of response and toxicity.
(2) Pregnancy or breast feeding.
(3) Previous chemotherapy within 4 weeks of start of trial treatment.
(4) Extensive radiotherapy within 4 weeks of start of trial therapy.
(5) Cerebral metastases. If the possibility of cerebral metastases is clinically indicated appropriate investigation should be undertaken before the patient is considered for participation in the study.
(6) Evidence of Gilbert’s syndrome.
(7) Prior treatment with irinotecan.

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)
Open randomisation, not blinded
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generation software, stratification using blocking.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
9/06/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC,QLD,SA,WA,TAS
Recruitment postcode(s) [1] 4101 0
2050
Recruitment postcode(s) [2] 4102 0
2050
Recruitment postcode(s) [3] 4109 0
2050
Recruitment postcode(s) [4] 5029 0
2050, 2137, 2031, 3350, 3084, 3065, 7000, 6000, 6009, 6008, 6230,
Recruitment outside Australia
Country [1] 190 0
New Zealand
State/province [1] 190 0
Christchurch, South Island, New Zealand

Funding & Sponsors
Funding source category [1] 589 0
Commercial sector/Industry
Name [1] 589 0
Pfizer Educational Grant
Country [1] 589 0
Australia
Primary sponsor type
Other Collaborative groups
Name
AGITG
Address
GI CANCER Institute
Medical Foundation Building
University of Sydney
Level 6 92-94 Parramatta Road
Camperdown NSW 2050
Country
Australia
Secondary sponsor category [1] 478 0
None
Name [1] 478 0
N/A
Address [1] 478 0
Country [1] 478 0
Other collaborator category [1] 260574 0
University
Name [1] 260574 0
NHMRC Clinical Trials Centre, University of Sydney
Address [1] 260574 0
Locked Bag 77
Camperdown NSW 1450
Country [1] 260574 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1644 0
Christchurch Hospital
Ethics committee address [1] 1644 0
Ethics committee country [1] 1644 0
New Zealand
Date submitted for ethics approval [1] 1644 0
Approval date [1] 1644 0
Ethics approval number [1] 1644 0
Ethics committee name [2] 1645 0
Concord Repatriation General Hospital
Ethics committee address [2] 1645 0
Ethics committee country [2] 1645 0
Australia
Date submitted for ethics approval [2] 1645 0
Approval date [2] 1645 0
Ethics approval number [2] 1645 0
Ethics committee name [3] 1646 0
Prince of Wales Hospital
Ethics committee address [3] 1646 0
Ethics committee country [3] 1646 0
Australia
Date submitted for ethics approval [3] 1646 0
Approval date [3] 1646 0
Ethics approval number [3] 1646 0
Ethics committee name [4] 1647 0
Royal Perth Hospital
Ethics committee address [4] 1647 0
Ethics committee country [4] 1647 0
Australia
Date submitted for ethics approval [4] 1647 0
Approval date [4] 1647 0
Ethics approval number [4] 1647 0
Ethics committee name [5] 1648 0
Royal Hobart Hospital
Ethics committee address [5] 1648 0
Ethics committee country [5] 1648 0
Australia
Date submitted for ethics approval [5] 1648 0
Approval date [5] 1648 0
Ethics approval number [5] 1648 0
Ethics committee name [6] 1649 0
St Vincent's Hospital
Ethics committee address [6] 1649 0
Ethics committee country [6] 1649 0
Australia
Date submitted for ethics approval [6] 1649 0
Approval date [6] 1649 0
Ethics approval number [6] 1649 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35585 0
Address 35585 0
Country 35585 0
Phone 35585 0
Fax 35585 0
Email 35585 0
Contact person for public queries
Name 9613 0
DAVINCI Trial Coordinator
Address 9613 0
National Health and Medical Research Council (NHMRC) Clinical Trials Centre
Locked Bag 77
Camperdown NSW 1450
Country 9613 0
Australia
Phone 9613 0
+61 2 9562 5000
Fax 9613 0
+61 2 9562 5094
Email 9613 0
agitg_operations@ctc.usyd.edu.au
Contact person for scientific queries
Name 541 0
DAVINCI Trial Coordinator
Address 541 0
National Health and Medical Research Council (NHMRC) Clinical Trials Centre Locked Bag 77 Camperdown NSW 1450
Country 541 0
Australia
Phone 541 0
+61 2 9562 5000
Fax 541 0
+61 2 9562 5094
Email 541 0
agitg_operations@ctc.usyd.edu.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.