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Capecitabine and Oxaliplatin Adjuvant Study in Stomach Cancer (CLASSIC)

This study has been completed.
Sponsor:
Collaborator:
Hoffmann-La Roche
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT00411229
First received: December 12, 2006
Last updated: February 18, 2013
Last verified: February 2013

December 12, 2006
February 18, 2013
June 2006
November 2012   (final data collection date for primary outcome measure)
  • Recurrence of the original cancer [ Time Frame: From the beginning to end of the study ] [ Designated as safety issue: No ]
  • Development of a new gastric cancer [ Time Frame: From beginning to end of study ] [ Designated as safety issue: No ]
  • Death due to any cause [ Time Frame: From the beginning to the end of study ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: From beginning to end of study ] [ Designated as safety issue: Yes ]
  • Clinical laboratory tests [ Time Frame: From beginning to end of study ] [ Designated as safety issue: No ]
  • Recurrence of the original cancer
  • Development of a new gastric cancer
  • Death due to any cause
  • Adverse events
  • Clinical laboratory tests
Complete list of historical versions of study NCT00411229 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Capecitabine and Oxaliplatin Adjuvant Study in Stomach Cancer
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Stomach Neoplasms
  • Drug: Capecitabine
    1,000 mg/m² twice daily. Film coated tablets of 500 mg, 150mg.
  • Drug: Oxaliplatin
    IV infusion, 130mg/m²
  • Active Comparator: 1
    Capecitabine + Oxalipatin
    Interventions:
    • Drug: Capecitabine
    • Drug: Oxaliplatin
  • No Intervention: 2
Bang YJ, Kim YW, Yang HK, Chung HC, Park YK, Lee KH, Lee KW, Kim YH, Noh SI, Cho JY, Mok YJ, Kim YH, Ji J, Yeh TS, Button P, Sirzén F, Noh SH; CLASSIC trial investigators. Adjuvant capecitabine and oxaliplatin for gastric cancer after D2 gastrectomy (CLASSIC): a phase 3 open-label, randomised controlled trial. Lancet. 2012 Jan 28;379(9813):315-21. doi: 10.1016/S0140-6736(11)61873-4. Epub 2012 Jan 7.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1035
November 2012
November 2012   (final data collection date for primary outcome measure)

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.

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
China,   Korea, Republic of,   Taiwan
 
NCT00411229
L_9570, M017527
Not Provided
Sanofi
Sanofi
Hoffmann-La Roche
Study Director: Clinical Sciences & Operations Sanofi
Sanofi
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP