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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00275210




Registration number
NCT00275210
Ethics application status
Date submitted
3/01/2006
Date registered
11/01/2006
Date last updated
20/04/2009

Titles & IDs
Public title
MOSAIC - Multicenter International Study of Oxaliplatin/ 5FU-LV in the Adjuvant Treatment of Colon Cancer
Scientific title
Multicenter International Study of Oxaliplatin/ 5FU-LV in the Adjuvant Treatment of Colon Cancer
Secondary ID [1] 0 0
EFC3313
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colonic Neoplasms 0 0
Condition category
Condition code
Cancer 0 0 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Oxaliplatin (SR96669)

Treatment: Drugs: Oxaliplatin (SR96669)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To to detect occurrence of relapse the following examinations have to be performed for 5 years:
Timepoint [1] 0 0
Primary outcome [2] 0 0
Every 6 months for ultrasound or abdominopelvic CT scan and CEA determination,
Timepoint [2] 0 0
Primary outcome [3] 0 0
Every year for chest X-ray and colonoscopy for non polyp free patient,
Timepoint [3] 0 0
Primary outcome [4] 0 0
Every 3 years colonoscopy for polyp free patient
Timepoint [4] 0 0
Secondary outcome [1] 0 0
Every 2 weeks clinical and laboratory tests (hematological, creatinine and liver tests) for safety evaluation during treatment then every 6 months neurological examination Date of death for OS
Timepoint [1] 0 0

Eligibility
Key inclusion criteria
Main selection criteria:

- Histologically proven stage Dukes " B2 " (stage II: T3-T4 N0 M0) and " C " (stage III:
any T N1-2 M0) colon carcinoma. The inferior pole of the tumor must be above the
peritoneal reflection (> 15 cm from the anal margin)·

- Complete resection of the primary tumor without gross or microscopic evidence of
residual disease

- Treatment within 7 weeks following surgery

- Age 18-75 years old

- ECOG PS £ 2

- No prior chemo, immuno or radiotherapy
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/1998
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/04/2003
Sample size
Target
Accrual to date
Final
2246
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
sanofi-aventis Australia & New Zealand administrative office - Macquarie Park
Recruitment postcode(s) [1] 0 0
- Macquarie Park
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Wien
Country [2] 0 0
Belgium
State/province [2] 0 0
Diegem
Country [3] 0 0
Denmark
State/province [3] 0 0
Horsholm
Country [4] 0 0
France
State/province [4] 0 0
Paris
Country [5] 0 0
Germany
State/province [5] 0 0
Berlin
Country [6] 0 0
Greece
State/province [6] 0 0
Athens
Country [7] 0 0
Hungary
State/province [7] 0 0
Budapest
Country [8] 0 0
Israel
State/province [8] 0 0
Natanya
Country [9] 0 0
Italy
State/province [9] 0 0
Milano
Country [10] 0 0
Netherlands
State/province [10] 0 0
Gouda
Country [11] 0 0
Norway
State/province [11] 0 0
Lysaker
Country [12] 0 0
Poland
State/province [12] 0 0
Warszawa
Country [13] 0 0
Portugal
State/province [13] 0 0
Porto Salvo
Country [14] 0 0
Singapore
State/province [14] 0 0
Singapore
Country [15] 0 0
Spain
State/province [15] 0 0
Barcelona
Country [16] 0 0
Sweden
State/province [16] 0 0
Bromma
Country [17] 0 0
Switzerland
State/province [17] 0 0
Geneva
Country [18] 0 0
United Kingdom
State/province [18] 0 0
Guildford Surrey

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Sanofi
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
To evaluate the FOLFOX regimen versus LV5FU2 in the adjuvant treatment of stage II and III
colon cancer.

Primary objective: Disease Free Survival (DFS) Secondary objective: Overall Survival (OS),
safety (including long term toxicity)
Trial website
https://clinicaltrials.gov/ct2/show/NCT00275210
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Aimery de Gramont, MD
Address 0 0
Hopital saint-Antoine, Oncology department
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00275210