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

Colonic Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00263055
• Other study ID #: R_9262
• Status: Completed
• Phase: Phase 4
• First received: December 6, 2005
• Last updated: September 14, 2009
• Start date: August 2004

Study information

• Verified date: September 2009
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. primary completion date: June 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colonic Neoplasms

Intervention

Drug:
• oxaliplatin

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

China,  Hong Kong,  Korea, Republic of,  Taiwan,  Thailand, 

Outcome

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