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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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.
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
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metastatic colorectal cancer treated with FOLFOXIRI 3955 0
Condition category
Condition code
Cancer 4149 4149 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
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.
Intervention code [1] 3669 0
Not applicable
Comparator / control treatment
uncontrolled
Control group
Uncontrolled

Outcomes
Primary outcome [1] 5045 0
Overall survival
Timepoint [1] 5045 0
Anually for 5 years after diagnosis
Secondary outcome [1] 8491 0
Progression free survival
Timepoint [1] 8491 0
Anually for 5 years after diagnosis

Eligibility
Key inclusion criteria
Metastatic colorectal cancer;
Unresectable disease at diagnosis;
First-line treatment with FOLFOXIRI
Minimum age
18 Years
Maximum age
75 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Treatment with chemotherapy different from FOLFOXIRI;
Eastern Cooperative Oncology Group (ECOG) Performance status (PS) >2

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 1366 0
Italy
State/province [1] 1366 0

Funding & Sponsors
Funding source category [1] 4134 0
Self funded/Unfunded
Name [1] 4134 0
Address [1] 4134 0
Country [1] 4134 0
Primary sponsor type
Other Collaborative groups
Name
Gruppo Oncologico del Nord-Ovest "GONO"
Address
Viale Alfieri 36, Livorno
Country
Italy
Secondary sponsor category [1] 3719 0
None
Name [1] 3719 0
Address [1] 3719 0
Country [1] 3719 0

Ethics approval
Ethics application status
Approved

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
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29112 0
Address 29112 0
Country 29112 0
Phone 29112 0
Fax 29112 0
Email 29112 0
Contact person for public queries
Name 12269 0
Enrico Vasile
Address 12269 0
Viale Alfieri 36,
57100 Livorno
Country 12269 0
Italy
Phone 12269 0
+39 0586 223458
Fax 12269 0
Email 12269 0
envasile@tin.it
Contact person for scientific queries
Name 3197 0
Enrico Vasile
Address 3197 0
Viale Alfieri 36,
57100 Livorno
Country 3197 0
Italy
Phone 3197 0
+39 0586 223458
Fax 3197 0
Email 3197 0
envasile@tin.it

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary