Phase
Condition
Digestive System Neoplasms
Stomach Cancer
Gastric Cancer
Treatment
N/AClinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Age 18 -75
Histologically or cytologically proven in operable advanced gastric adenocarcinoma (including adenocarcinoma of the gastrooesophageal junction)
ECOG performance status ≦2
Tumor stage T3/4NxM0
No distant metastasis (M0)
Exclusion
Exclusion Criteria:
History of hypersensitivity to fluoropyrimidines, Tegafur,Gimeracil and OteracilPotassium Capsules , capecitabine, oxaliplatin or the ingredients of this product
Inadequate hematopoietic function: WBC≦4,000/mm3; ANC≦2,000/mm3; Platelet≦100,000/mm3
Inadequate organ function which is defined as below: Total bilirubin >2 pper limit of normal range (ULN); ALT / AST > 2.5 upper limit of normalrange (ULN) (>5.0 x ULN if hepatic metastasis); serum creatinine > 1.2 mg/dL, and Ccr > 60ml/min (estimated by Cockcroft-Gault formulation);
Symptomatic peripheral neuropathy
Receiving a concomitant treatment with other fluoropyrimidines
Pregnancy or lactation women, or women with suspected pregnancy or men unless using areliable and appropriate contraceptive method.
Mental status is not fit for chemotherapy therapy presence of serious concomitantillness which might be aggravated by study medication:
Active cardiac disease e.g. decompensate myocardial infarction within the 6-monthperiod preceding entry into the study.
History of ventricular arrhythmia or congestive heart failure.
Significant co-morbid medical conditions, including, but not limited to, Chronicobstructive pulmonary disease, interstitial pneumonia ,pulmonary fibrosis, heartfailure, renal failure, hepatic failure, haemorrhagic peptic ulcer, mechanical orparalytic ileus, or poorly controlled diabetes.
Study Design
Connect with a study center
Department of General Surgery
Shijiazhuang, Hebei 050011
ChinaSite Not Available
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