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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00263055
Recruitment Status : Completed
First Posted : December 7, 2005
Last Update Posted : September 15, 2009
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Brief Summary:
Safety & tolerability of FOLFOX4 regimen in the adjuvant treatment of colon cancer in Asian patients

Condition or disease Intervention/treatment Phase
Colonic Neoplasms Drug: oxaliplatin Phase 4

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Study Type : Interventional  (Clinical Trial)
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multicenter Asia Study in Adjuvant Treatment of Colon Cancer With OxaliplaTin/5FU-LV
Study Start Date : August 2004
Actual Primary Completion Date : June 2005

Resource links provided by the National Library of Medicine

Drug Information available for: Oxaliplatin

Primary Outcome Measures :
  1. Occurrence of dose-limiting toxicity [ Time Frame: from the inform consent signed up to the end of the study ]

Secondary Outcome Measures :
  1. 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 ]
  2. Overall distribution of intensity of adverse events [ Time Frame: from the inform consnet signed up to the end of the study ]
  3. Occurrence of particular adverse events and their intensities [ Time Frame: from the inform consent signed up to the end of the study ]
  4. Percent of patients completing study treatment [ Time Frame: from the inform consent signed up to the end of the study ]
  5. Percent of patients with grade 1, 2 and 3 neuropathy [ Time Frame: at 28 days, 6 months and 12 months after last chemotherapy administration. ]
  6. 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 ]
  7. Delays in scheduled dosing [ Time Frame: During the study conduct ]
  8. 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 ]
  9. •Survival Analysis •Laboratory assay and vital signs ECOG and KPS [ Time Frame: during the study conduct ]
  10. Long term toxicity [ Time Frame: during the study conduct ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00263055

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Beijing, China
Hong Kong
Hong Kong, Hong Kong
Korea, Republic of
Seoul, Korea, Republic of
Taipei, Taiwan
Bangkok, Thailand
Sponsors and Collaborators
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Study Director: Claude Valterio, MD Sanofi

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Responsible Party: Medical Affairs Study Director, sanofi-aventis Identifier: NCT00263055     History of Changes
Other Study ID Numbers: R_9262
First Posted: December 7, 2005    Key Record Dates
Last Update Posted: September 15, 2009
Last Verified: September 2009
Additional relevant MeSH terms:
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Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Colonic Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Antineoplastic Agents