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

NCT00263055 | Completed Phase 4

• 1 other identifier: R_9262
• Study Type: interventional
• Target: N/A
• Locations: 5 countries
• Sites: 5

Brief Summary

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

Conditions

Colonic Neoplasms

Outcome Measures

Primary Outcomes (1)

• Occurrence of dose-limiting toxicity

  from the inform consent signed up to the end of the study

Secondary Outcomes (10)

• Occurrence of one or more adverse event in a patient

  From the Informed Consent Form (ICF) signature to the end of the study

• Overall distribution of intensity of adverse events

  from the inform consnet signed up to the end of the study

• Occurrence of particular adverse events and their intensities

  from the inform consent signed up to the end of the study

• Percent of patients completing study treatment

  from the inform consent signed up to the end of the study

• Percent of patients with grade 1, 2 and 3 neuropathy

  at 28 days, 6 months and 12 months after last chemotherapy administration.

Interventions

oxaliplatin DRUG

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (5)

Sanofi-Aventis

Beijing, China

Location

Sanofi-Aventis

Hong Kong, Hong Kong

Location

Sanofi-aventis

Seoul, South Korea

Location

Sanofi-Aventis

Taipei, Taiwan

Location

Sanofi-Aventis

Bangkok, Thailand

Location

MeSH Terms

Conditions

Colonic Neoplasms

Interventions

Oxaliplatin

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals

Study Officials

• Claude Valterio, MD

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 6, 2005
• First Posted: December 7, 2005
• Study Start: August 1, 2004
• Primary Completion: June 1, 2005
• Last Updated: September 15, 2009

Record last verified: 2009-09

Locations

TH (1); KR (1); CN (1); TW (1); HK (1)