MASCOT : Multicenter Asia Study in Adjuvant Treatment of Colon Cancer With OxaliplaTin/5FU-LV - Full Text View

Sponsored by:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00263055

Purpose

Safety & tolerability of FOLFOX4 regimen in the adjuvant treatment of colon cancer in Asian patients

Condition	Intervention	Phase
Colonic Neoplasms	Drug: oxaliplatin	Phase IV

MedlinePlus related topics: Cancer

Drug Information available for: Fluorouracil Oxaliplatin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety Study
Official Title:	Multicenter Asia Study in Adjuvant Treatment of Colon Cancer With OxaliplaTin/5FU-LV

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

Occurrence of dose-limiting toxicity [ Time Frame: from the inform consent signed up to the end of the study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Occurrence of one or more adverse event in a patient [ Time Frame: From the Informed Consent Form (ICF) signature to the end of the study ] [ Designated as safety issue: No ]
Overall distribution of intensity of adverse events [ Time Frame: from the inform consnet signed up to the end of the study ] [ Designated as safety issue: No ]
Occurrence of particular adverse events and their intensities [ Time Frame: from the inform consent signed up to the end of the study ] [ Designated as safety issue: No ]
Percent of patients completing study treatment [ Time Frame: from the inform consent signed up to the end of the study ] [ Designated as safety issue: No ]
Percent of patients with grade 1, 2 and 3 neuropathy [ Time Frame: at 28 days, 6 months and 12 months after last chemotherapy administration. ] [ Designated as safety issue: No ]
Percent of intended dose delivered for 5-FU/LV and Oxaliplatin [ Time Frame: from the informed consent signed up to the end of the study ] [ Designated as safety issue: No ]
Delays in scheduled dosing [ Time Frame: During the study conduct ] [ Designated as safety issue: No ]
Dose intensity, as expressed as the amount of 5-FU/LV and Oxaliplatin administered divided by the duration of treatment [ Time Frame: during the study conduct ] [ Designated as safety issue: No ]
•Survival Analysis •Laboratory assay and vital signs ECOG and KPS [ Time Frame: during the study conduct ] [ Designated as safety issue: No ]
Long term toxicity [ Time Frame: during the study conduct ] [ Designated as safety issue: No ]

Study Start Date:	August 2004
Primary Completion Date:	June 2005 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion 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).
Patients must have undergone complete resection of the primary tumor without gross or microscopic evidence of residual disease
Patients must be entered in the study in order to start treatment within 7 weeks after surgery
Age 18-75 years old
Performance Status ≤ 2 (Karnofsky > or = 60%)
No previous chemotherapy, immunotherapy or radiotherapy
No biological major abnormalities :Absolute neutrophil count > 1.5 x 10^9/l,Platelets ≥ 100 x 10^9/l,Serum creatinine ≤ 1.25 times the upper limit of normal, total bilirubin, ASAT / ALAT < 2 times the upper limit of the normal range,carcinoembryonic antigen < 10 ng/ml.
Documentation of a negative pregnancy test must be available for premenopausal women with intact reproductive organs
Men and women who are fertile must use a medically acceptable contraceptive throughout the treatment period and for 3 months following cessation of treatment with oxaliplatin. Subjects must be made aware, before entering this trial of the risk of becoming pregnant or in fathering children
Signed informed consent obtained prior to study entry

Exclusion criteria

Pregnant or lactating women
Women of child bearing potential not using a contraceptive method
Previous cancer of the colon or rectum
Previous malignancies other than adequately treated in situ carcinoma of the uterine cervix or basal or squamous cell carcinoma of the skin, unless there has been a disease-free interval of at least 10 years
Participation in another clinical trial with any investigational drug within 30 days prior to randomization
Peripheral neuropathy (NCI CTC [National Cancer Institute Common Toxicity Criteria] > or = Grade I)
Uncontrolled congestive heart failure or angina pectoris, or hypertension or arrhythmia
History of significant neurologic or psychiatric disorders
Active infection

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00263055

Locations

China
Sanofi-Aventis
Beijing, China
Hong Kong
Sanofi-Aventis
Hong Kong, Hong Kong
Korea, Republic of
Sanofi-aventis
Seoul, Korea, Republic of
Taiwan
Sanofi-Aventis
Taipei, Taiwan
Thailand
Sanofi-Aventis
Bangkok, Thailand

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

Claude Valterio, MD

Sanofi-Aventis

More Information

CSR Synopsis This link exits the ClinicalTrials.gov site

Responsible Party:	sanofi-aventis ( Medical Affairs Study Director )
Study ID Numbers:	R_9262
Study First Received:	December 6, 2005
Last Updated:	July 28, 2008
ClinicalTrials.gov Identifier:	NCT00263055
Health Authority:	China: Ministry of Health

Study placed in the following topic categories:

Oxaliplatin
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Fluorouracil
Colonic Diseases

Gastrointestinal Neoplasms
Intestinal Diseases
Colonic Neoplasms
Intestinal Neoplasms
Colorectal Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009