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Trial registered on ANZCTR
Registration number
ACTRN12608000615381
Ethics application status
Approved
Date submitted
7/11/2008
Date registered
8/12/2008
Date last updated
8/12/2008
Type of registration
Retrospectively registered
Titles & IDs
Public title
Evaluation of initially unresectable metastatic colorectal cancer patients treated with 5-fluorouracil/leucovorin, oxaliplatin and irinotecan (FOLFOXIRI) followed by radical surgery of metastases.
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Scientific title
Evaluation of overall survival of initially unresectable metastatic colorectal cancer patients treated with 5-fluorouracil/leucovorin, oxaliplatin and irinotecan (FOLFOXIRI) followed by radical surgery of metastases
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Metastatic colorectal cancer treated with FOLFOXIRI
3955
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Condition category
Condition code
Cancer
4149
4149
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0
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Bowel - Back passage (rectum) or large bowel (colon)
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Observation: metastatic colorectal cancer patients who have been treated in first-line with FOLFOXIRI (a triple drug combination of irinotecan 165 mg/square meter ("sqm") endovenous ("ev") in 1 hour, oxaliplatin 85 mg/sqm ev in 2 hours and 5-fluorouracil 3200 mg/sqm as a 48-hour continous infusion ev plus leucovorin 200 mg/sqm ev in 2 hours, every 14 days for 12 cycles) and who underwent radical surgical resection of metastases will be followed up yearly for 5 years after the diagnosis of disease to collect their survival status.
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Intervention code [1]
3669
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Not applicable
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Comparator / control treatment
uncontrolled
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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Overall survival
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Assessment method [1]
5045
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Timepoint [1]
5045
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Anually for 5 years after diagnosis
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Secondary outcome [1]
8491
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Progression free survival
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Assessment method [1]
8491
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Timepoint [1]
8491
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Anually for 5 years after diagnosis
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Eligibility
Key inclusion criteria
Metastatic colorectal cancer;
Unresectable disease at diagnosis;
First-line treatment with FOLFOXIRI
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Minimum age
18
Years
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Maximum age
75
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Treatment with chemotherapy different from FOLFOXIRI;
Eastern Cooperative Oncology Group (ECOG) Performance status (PS) >2
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Study design
Purpose
Natural history
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Duration
Longitudinal
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Selection
Defined population
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
1/05/1999
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
37
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Accrual to date
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Final
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Recruitment outside Australia
Country [1]
1366
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Italy
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State/province [1]
1366
0
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Funding & Sponsors
Funding source category [1]
4134
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Self funded/Unfunded
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Name [1]
4134
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Address [1]
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Country [1]
4134
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Primary sponsor type
Other Collaborative groups
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Name
Gruppo Oncologico del Nord-Ovest "GONO"
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Address
Viale Alfieri 36, Livorno
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Country
Italy
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Secondary sponsor category [1]
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None
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Name [1]
3719
0
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Address [1]
3719
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Country [1]
3719
0
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Ethics approval
Ethics application status
Approved
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Summary
Brief summary
The primary purpose of the study is to verify if patients with metastatic colorectal cancer, who have been treated with first-line triple drug combination FOLFOXIRI and who have underwnt to radical surgical resection of metastases, may reach a prolonged overall survival and so a chance of cure for their metastatic diseases
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
29112
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Email
29112
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Contact person for public queries
Name
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Enrico Vasile
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Address
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Viale Alfieri 36,
57100 Livorno
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Country
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Italy
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Phone
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+39 0586 223458
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Fax
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Email
12269
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[email protected]
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Contact person for scientific queries
Name
3197
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Enrico Vasile
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Address
3197
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Viale Alfieri 36,
57100 Livorno
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Country
3197
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Italy
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Phone
3197
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+39 0586 223458
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Fax
3197
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Email
3197
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[email protected]
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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.
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