Clinical trial NCT00263055: MASCOT : Multicenter Asia Study in Adjuvant Treatment of Colon Cancer With OxaliplaTin/5FU-LV
Official title: Multicenter Asia Study in Adjuvant Treatment of Colon Cancer With OxaliplaTin/5FU-LV
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Colonic Neoplasms
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2005-12-07
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Safety \& tolerability of FOLFOX4 regimen in the adjuvant treatment of colon cancer in Asian patients


Eligibility 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.

Primary outcomes:
measure: Occurrence of dose-limiting toxicity
timeFrame: from the inform consent signed up to the end of the study
Secondary outcomes:
measure: Occurrence of one or more adverse event in a patient
timeFrame: From the Informed Consent Form (ICF) signature to the end of the study
measure: Overall distribution of intensity of adverse events
timeFrame: from the inform consnet signed up to the end of the study
measure: Occurrence of particular adverse events and their intensities
timeFrame: from the inform consent signed up to the end of the study
measure: Percent of patients completing study treatment
timeFrame: from the inform consent signed up to the end of the study
measure: Percent of patients with grade 1, 2 and 3 neuropathy
timeFrame: at 28 days, 6 months and 12 months after last chemotherapy administration.
measure: Percent of intended dose delivered for 5-FU/LV and Oxaliplatin
timeFrame: from the informed consent signed up to the end of the study
measure: Delays in scheduled dosing
timeFrame: During the study conduct
measure: Dose intensity, as expressed as the amount of 5-FU/LV and Oxaliplatin administered divided by the duration of treatment
timeFrame: during the study conduct
measure: •Survival Analysis •Laboratory assay and vital signs ECOG and KPS
timeFrame: during the study conduct
measure: Long term toxicity
timeFrame: during the study conduct
Other outcomes:
Locations:
city: Beijing
country: China
facility: Sanofi-Aventis
city: Hong Kong
country: Hong Kong
facility: Sanofi-Aventis
city: Seoul
country: Korea, Republic of
facility: Sanofi-aventis
city: Taipei
country: Taiwan
facility: Sanofi-Aventis
city: Bangkok
country: Thailand
facility: Sanofi-Aventis
Study officials:
affiliation: Sanofi
name: Claude Valterio, MD
role: STUDY_DIRECTOR
References: