Capecitabine and Oxaliplatin Adjuvant Study in Stomach Cancer (CLASSIC)

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ClinicalTrials.gov Identifier: NCT00411229

Recruitment Status : Completed

First Posted : December 13, 2006

Last Update Posted : February 20, 2013

View this study on the modernized ClinicalTrials.gov

Sponsor:

Collaborator:

Hoffmann-La Roche

Information provided by (Responsible Party):

Sanofi

Tracking Information

First Submitted Date ^ICMJE

December 12, 2006

First Posted Date ^ICMJE

December 13, 2006

Last Update Posted Date

February 20, 2013

Study Start Date ^ICMJE

June 2006

Actual Primary Completion Date

November 2012 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Recurrence of the original cancer [ Time Frame: From the beginning to end of the study ]
Development of a new gastric cancer [ Time Frame: From beginning to end of study ]
Death due to any cause [ Time Frame: From the beginning to the end of study ]
Adverse events [ Time Frame: From beginning to end of study ]
Clinical laboratory tests [ Time Frame: From beginning to end of study ]

Original Primary Outcome Measures ^ICMJE

Recurrence of the original cancer
Development of a new gastric cancer
Death due to any cause
Adverse events
Clinical laboratory tests

Change History

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Pre-specified Outcome Measures

Not Provided

Original Other Pre-specified Outcome Measures

Not Provided

Descriptive Information

Brief Title ^ICMJE

Capecitabine and Oxaliplatin Adjuvant Study in Stomach Cancer

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase ^ICMJE

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Condition ^ICMJE

Stomach Neoplasms

Intervention ^ICMJE

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

Study Arms ^ICMJE

Active Comparator: 1
Capecitabine + Oxalipatin
Interventions:
- Drug: Capecitabine
- Drug: Oxaliplatin
No Intervention: 2

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Actual Enrollment ^ICMJE

1035

Original Enrollment ^ICMJE

1024

Actual Study Completion Date ^ICMJE

November 2012

Actual Primary Completion Date

November 2012 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Sex/Gender ^ICMJE

Sexes Eligible for Study:

All

Ages ^ICMJE

18 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers ^ICMJE

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

China, Korea, Republic of, Taiwan

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00411229

Other Study ID Numbers ^ICMJE

L_9570
M017527

Has Data Monitoring Committee

Not Provided

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement ^ICMJE

Not Provided

Current Responsible Party

Sanofi

Original Responsible Party

Not Provided

Current Study Sponsor ^ICMJE

Sanofi

Original Study Sponsor ^ICMJE

Same as current

Collaborators ^ICMJE

Hoffmann-La Roche

Investigators ^ICMJE

Study Director:

Clinical Sciences & Operations

Sanofi

PRS Account

Sanofi

Verification Date

February 2013

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

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