Official Title: “A Phase III Study Comparing Adjuvant Chemotherapy Consisting of Capecitabine/Oxaliplatin vs Surgery Alone in Patients With Stage II (T1N2, T2N1, T3N0), IIIa (T2N2, T3N1, T4NO), and IIIb (T3N2) Gastric Adenocarcinoma”

Primary: - To demonstrate that capecitabine/oxaliplatin as adjuvant chemotherapy is superior to observation alone in terms of 3 year disease-free survival (DFS) rate in chemotherapy-naïve patients who underwent potentially curative resection for gastric cancer.

Secondary: - To compare the overall survival of surgery and capecitabine/ oxaliplatin as adjuvant therapy versus surgery alone. To evaluate the safety profile of capecitabine/oxaliplatin adjuvant therapy.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: March 2010

Intervention(s) in this Clinical Trial

• Drug: Capecitabine
  • 1,000 mg/m² twice daily. Film coated tablets of 500 mg, 150mg.
• Drug: Oxaliplatin
  • IV infusion, 130mg/m²

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • Capecitabine + Oxalipatin
• No Intervention: 2

Primary Measures

• Recurrence of the original cancer
  • Time Frame: From the beginning to end of the study
    Safety Issue?: No
• Development of a new gastric cancer
  • Time Frame: From beginning to end of study
    Safety Issue?: No
• Death due to any cause
  • Time Frame: From the beginning to the end of study
    Safety Issue?: No
• Adverse events
  • Time Frame: From beginning to end of study
    Safety Issue?: Yes
• Clinical laboratory tests
  • Time Frame: From beginning to end of study
    Safety Issue?: No

Inclusion Criteria:

• Ambulatory patients
• Karnofsky performance status of ≥70 %.
• Histologically confirmed gastric adenocarcinoma, staged pathologically, stage II (T2N1, T1N2, T3N0), IIIa (T3N1, T2N2, T4N0), and IIIb (T3N2). At least 15 examined lymph nodes are required to ensure the adequate TNM (Tumor Nodes Metastases classification.
• Patients who underwent curative D2 lymphadenectomy resection for gastric cancer with no macroscopic or microscopic evidence for remaining tumor, who can be randomized to either study arm within 6 weeks after surgery.

Exclusion Criteria:

• Pregnant or lactating women.
• Women of childbearing potential with either a positive or no pregnancy test at baseline. Postmenopausal women must have been amenorrheic for at least 12 months to be considered of non-child bearing potential.
• Sexually active males and females (of childbearing potential) unwilling to practice contraception during the study.
• Any evidence of metastatic disease (including presence of tumor cells in the ascites).
• Previous cytotoxic chemotherapy, radiotherapy or immunotherapy except corticosteroids, for the currently treated gastric cancer.
• Major surgery within 4 weeks prior to study treatment start, or lack of complete recovery from the effects of major surgery.
• History of another malignancy within the last five years except cured basal cell carcinoma of skin and cured carcinoma in-situ of uterine cervix.
• Clinically significant (i.e. active) cardiac disease e.g. symptomatic coronary artery disease, New York Heart Association (NYHA) grade II or greater congestive heart failure or serious cardiac arrhythmia requiring medication or myocardial infarction within the last 12 months.
• Lack of physical integrity of the upper gastrointestinal tract or those who have malabsorption syndrome likely to influence absorption of capecitabine, or inability to take oral medication.
• Known peripheral neuropathy ≥ CTCAEv3 grade 1 (Common Terminology for Adverse Events).
• Absence of deep tendon reflexes as the sole neurologic abnormality does not render the patient ineligible.
• Organ allografts requiring immunosuppressive therapy.
• Serious uncontrolled intercurrent infections or other serious uncontrolled concomitant disease.
• Moderate or severe renal impairment [creatinine clearance equal to or below 50 ml/min (calculated according to Cockroft and Gault)], or serum creatinine > 1.5 x upper limit of normal (ULN).
• Any of the following laboratory values:
• Absolute neutrophil count (ANC) < 1.5 x 109/L
• Platelet count < 100 x 109/L
• Total bilirubin > 1.5 x ULN
• ALAT, ASAT > 2.5 x ULN
• Alkaline phosphatase > 2.5 x ULN.
• Prior unanticipated severe reaction to fluoropyrimidine therapy (with or without documented dihydropyrimidine dehydrogenase (DPD) deficiency) or patients with known
• DPD deficiency.
• Hypersensitivity to platinum compounds or any of the components of the study medications.
• Received any investigational drug or agent/procedure, i.e. participation in another trial, within 4 weeks before randomization.
• Blood transfusions or growth factors to aid hematologic recovery within 2 weeks prior to study treatment start.
• Requirement for concurrent use of the antiviral agent sorivudine (antiviral) or chemically related analogues, such as brivudine.
• The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Sanofi-Aventis

Overall Clinical Trial Officials and Contacts

Han Lim Moon, MD & PhD Study Director Sanofi-Aventis  

Overall Contact: Public Registry GMA  PublicRegistryGMA@sanofi-aventis.com

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00411229

Study ID Number: L_9570

ClinicalTrials.gov Identifier: NCT00411229

Health Authority: South Korea: Korea Food and Drug Administration (KFDA)