MOSAIC - Multicenter International Study of Oxaliplatin/ 5FU-LV in the Adjuvant Treatment of Colon Cancer
Primary Purpose
Colonic Neoplasms
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Oxaliplatin (SR96669)
Sponsored by
About this trial
This is an interventional treatment trial for Colonic Neoplasms focused on measuring Oxaliplatin, Chemotherapy,adjuvant, Colonic Neoplasms
Eligibility 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
Sites / Locations
- sanofi-aventis Australia & New Zealand administrative office
- Sanofi-Aventis Administrative Office
- Sanofi-Aventis Administrative Office
- Sanofi-Aventis Administrative Office
- Sanofi-Aventis Administrative Office
- Sanofi-Aventis Administrative Office
- Sanofi-Aventis Administrative Office
- Sanofi-Aventis Administrative Office
- Sanofi-Aventis Administrative Office
- Sanofi-Aventis Administrative Office
- Sanofi-Aventis Administrative Office
- Sanofi-Aventis Administrative Office
- Sanofi-Aventis Administrative Office
- Sanofi-Aventis Administrative Office
- Sanofi-Aventis Administrative Office
- Sanofi-Aventis Administrative Office
- Sanofi-Aventis Administrative Office
- Sanofi-Aventis Administrative Office
- Sanofi-Aventis Administrative Office
Outcomes
Primary Outcome Measures
To to detect occurrence of relapse the following examinations have to be performed for 5 years:
Every 6 months for ultrasound or abdominopelvic CT scan and CEA determination,
Every year for chest X-ray and colonoscopy for non polyp free patient,
Every 3 years colonoscopy for polyp free patient
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00275210
Brief Title
MOSAIC - Multicenter International Study of Oxaliplatin/ 5FU-LV in the Adjuvant Treatment of Colon Cancer
Official Title
Multicenter International Study of Oxaliplatin/ 5FU-LV in the Adjuvant Treatment of Colon Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
April 2009
Overall Recruitment Status
Completed
Study Start Date
October 1998 (undefined)
Primary Completion Date
April 2003 (Actual)
Study Completion Date
April 2003 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Sanofi
4. Oversight
5. Study Description
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colonic Neoplasms
Keywords
Oxaliplatin, Chemotherapy,adjuvant, Colonic Neoplasms
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2246 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Oxaliplatin (SR96669)
Primary Outcome Measure Information:
Title
To to detect occurrence of relapse the following examinations have to be performed for 5 years:
Title
Every 6 months for ultrasound or abdominopelvic CT scan and CEA determination,
Title
Every year for chest X-ray and colonoscopy for non polyp free patient,
Title
Every 3 years colonoscopy for polyp free patient
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aimery de Gramont, MD
Organizational Affiliation
Hopital saint-Antoine, Oncology department
Official's Role
Study Chair
Facility Information:
Facility Name
sanofi-aventis Australia & New Zealand administrative office
City
Macquarie Park
State/Province
New South Wales
Country
Australia
Facility Name
Sanofi-Aventis Administrative Office
City
Wien
Country
Austria
Facility Name
Sanofi-Aventis Administrative Office
City
Diegem
Country
Belgium
Facility Name
Sanofi-Aventis Administrative Office
City
Horsholm
Country
Denmark
Facility Name
Sanofi-Aventis Administrative Office
City
Paris
Country
France
Facility Name
Sanofi-Aventis Administrative Office
City
Berlin
Country
Germany
Facility Name
Sanofi-Aventis Administrative Office
City
Athens
Country
Greece
Facility Name
Sanofi-Aventis Administrative Office
City
Budapest
Country
Hungary
Facility Name
Sanofi-Aventis Administrative Office
City
Natanya
Country
Israel
Facility Name
Sanofi-Aventis Administrative Office
City
Milano
Country
Italy
Facility Name
Sanofi-Aventis Administrative Office
City
Gouda
Country
Netherlands
Facility Name
Sanofi-Aventis Administrative Office
City
Lysaker
Country
Norway
Facility Name
Sanofi-Aventis Administrative Office
City
Warszawa
Country
Poland
Facility Name
Sanofi-Aventis Administrative Office
City
Porto Salvo
Country
Portugal
Facility Name
Sanofi-Aventis Administrative Office
City
Singapore
Country
Singapore
Facility Name
Sanofi-Aventis Administrative Office
City
Barcelona
Country
Spain
Facility Name
Sanofi-Aventis Administrative Office
City
Bromma
Country
Sweden
Facility Name
Sanofi-Aventis Administrative Office
City
Geneva
Country
Switzerland
Facility Name
Sanofi-Aventis Administrative Office
City
Guildford Surrey
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
15175436
Citation
Andre T, Boni C, Mounedji-Boudiaf L, Navarro M, Tabernero J, Hickish T, Topham C, Zaninelli M, Clingan P, Bridgewater J, Tabah-Fisch I, de Gramont A; Multicenter International Study of Oxaliplatin/5-Fluorouracil/Leucovorin in the Adjuvant Treatment of Colon Cancer (MOSAIC) Investigators. Oxaliplatin, fluorouracil, and leucovorin as adjuvant treatment for colon cancer. N Engl J Med. 2004 Jun 3;350(23):2343-51. doi: 10.1056/NEJMoa032709.
Results Reference
result
PubMed Identifier
36306483
Citation
Gallois C, Shi Q, Meyers JP, Iveson T, Alberts SR, de Gramont A, Sobrero AF, Haller DG, Oki E, Shields AF, Goldberg RM, Kerr R, Lonardi S, Yothers G, Kelly C, Boukovinas I, Labianca R, Sinicrope FA, Souglakos I, Yoshino T, Meyerhardt JA, Andre T, Papamichael D, Taieb J. Prognostic Impact of Early Treatment and Oxaliplatin Discontinuation in Patients With Stage III Colon Cancer: An ACCENT/IDEA Pooled Analysis of 11 Adjuvant Trials. J Clin Oncol. 2023 Feb 1;41(4):803-815. doi: 10.1200/JCO.21.02726. Epub 2022 Oct 28.
Results Reference
derived
PubMed Identifier
36227604
Citation
Webster-Clark M, Keil AP, Robert N, Frytak JR, Boyd M, Sturmer T, Sanoff H, Westreich D, Lund JL. Comparing Trial and Real-world Adjuvant Oxaliplatin Delivery in Patients With Stage III Colon Cancer Using a Longitudinal Cumulative Dose. JAMA Oncol. 2022 Oct 13;8(12):1821-4. doi: 10.1001/jamaoncol.2022.4445. Online ahead of print.
Results Reference
derived
PubMed Identifier
33356421
Citation
Cohen R, Taieb J, Fiskum J, Yothers G, Goldberg R, Yoshino T, Alberts S, Allegra C, de Gramont A, Seitz JF, O'Connell M, Haller D, Wolmark N, Erlichman C, Zaniboni A, Lonardi S, Kerr R, Grothey A, Sinicrope FA, Andre T, Shi Q. Microsatellite Instability in Patients With Stage III Colon Cancer Receiving Fluoropyrimidine With or Without Oxaliplatin: An ACCENT Pooled Analysis of 12 Adjuvant Trials. J Clin Oncol. 2021 Feb 20;39(6):642-651. doi: 10.1200/JCO.20.01600. Epub 2020 Dec 23.
Results Reference
derived
PubMed Identifier
32085892
Citation
Salem ME, Yin J, Goldberg RM, Pederson LD, Wolmark N, Alberts SR, Taieb J, Marshall JL, Lonardi S, Yoshino T, Kerr RS, Yothers G, Grothey A, Andre T, De Gramont A, Shi Q. Evaluation of the change of outcomes over a 10-year period in patients with stage III colon cancer: pooled analysis of 6501 patients treated with fluorouracil, leucovorin, and oxaliplatin in the ACCENT database. Ann Oncol. 2020 Apr;31(4):480-486. doi: 10.1016/j.annonc.2019.12.007. Epub 2020 Jan 16.
Results Reference
derived
PubMed Identifier
31296923
Citation
Auclin E, Andre T, Taieb J, Banzi M, Van Laethem JL, Tabernero J, Hickish T, de Gramont A, Vernerey D. Association of post-operative CEA with survival and oxaliplatin benefit in patients with stage II colon cancer: a post hoc analysis of the MOSAIC trial. Br J Cancer. 2019 Aug;121(4):312-317. doi: 10.1038/s41416-019-0521-7. Epub 2019 Jul 12.
Results Reference
derived
PubMed Identifier
26527776
Citation
Andre T, de Gramont A, Vernerey D, Chibaudel B, Bonnetain F, Tijeras-Raballand A, Scriva A, Hickish T, Tabernero J, Van Laethem JL, Banzi M, Maartense E, Shmueli E, Carlsson GU, Scheithauer W, Papamichael D, Moehler M, Landolfi S, Demetter P, Colote S, Tournigand C, Louvet C, Duval A, Flejou JF, de Gramont A. Adjuvant Fluorouracil, Leucovorin, and Oxaliplatin in Stage II to III Colon Cancer: Updated 10-Year Survival and Outcomes According to BRAF Mutation and Mismatch Repair Status of the MOSAIC Study. J Clin Oncol. 2015 Dec 10;33(35):4176-87. doi: 10.1200/JCO.2015.63.4238. Epub 2015 Nov 2.
Results Reference
derived
PubMed Identifier
22915656
Citation
Tournigand C, Andre T, Bonnetain F, Chibaudel B, Lledo G, Hickish T, Tabernero J, Boni C, Bachet JB, Teixeira L, de Gramont A. Adjuvant therapy with fluorouracil and oxaliplatin in stage II and elderly patients (between ages 70 and 75 years) with colon cancer: subgroup analyses of the Multicenter International Study of Oxaliplatin, Fluorouracil, and Leucovorin in the Adjuvant Treatment of Colon Cancer trial. J Clin Oncol. 2012 Sep 20;30(27):3353-60. doi: 10.1200/JCO.2012.42.5645. Epub 2012 Aug 20.
Results Reference
derived
Learn more about this trial
MOSAIC - Multicenter International Study of Oxaliplatin/ 5FU-LV in the Adjuvant Treatment of Colon Cancer
We'll reach out to this number within 24 hrs