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Status:

COMPLETED

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

Lead Sponsor:

Sanofi

Conditions:

Colonic Neoplasms

Eligibility:

All Genders

18-75 years

Phase:

PHASE4

Brief Summary

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

Eligibility Criteria

Inclusion

  • 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.

Exclusion

    Key Trial Info

    Start Date :

    August 1 2004

    Trial Type :

    INTERVENTIONAL

    End Date :

    Estimated Enrollment :

    Patients enrolled

    Trial Details

    Trial ID

    NCT00263055

    Start Date

    August 1 2004

    Last Update

    September 15 2009

    Active Locations (5)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 2 (5 locations)

    1

    Sanofi-Aventis

    Beijing, China

    2

    Sanofi-Aventis

    Hong Kong, Hong Kong

    3

    Sanofi-aventis

    Seoul, South Korea

    4

    Sanofi-Aventis

    Taipei, Taiwan