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

Phase 4
18 Years
75 Years
Not Enrolling
Colonic Neoplasms

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Trial Information

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

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

- 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.

Type of Study:


Study Design:

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

Outcome Measure:

Occurrence of dose-limiting toxicity

Outcome Time Frame:

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

Safety Issue:


Principal Investigator

Claude Valterio, MD

Investigator Role:

Study Director

Investigator Affiliation:



China: Ministry of Health

Study ID:




Start Date:

August 2004

Completion Date:

Related Keywords:

  • Colonic Neoplasms
  • Neoplasms
  • Colonic Neoplasms