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

Sanofi1 site in 1 country1,035 target enrollmentJune 2006

ConditionsStomach Neoplasms

InterventionsCapecitabine Oxaliplatin

DrugsCapecitabine Oxaliplatin

Overview

Phase: Phase 3
Intervention: Capecitabine
Conditions: Stomach Neoplasms
Sponsor: Sanofi
Enrollment: 1035
Locations: 1
Primary Endpoint: Recurrence of the original cancer
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

June 2006

End Date

November 2012

Last Updated

13 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Sanofi

Responsible Party

Sponsor

Eligibility Criteria

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.