Gastric Cancer
Conditions
Keywords
Tegafur，Gimeracil and Oteracil Potassium Capsules, Capecitabine, Oxaliplatin, perioperative Chemotherapy, Gastric Cancer
Brief summary
Stage I：Neoadjuvant therapy * Tegafur，Gimeracil and Oteracil Potassium Capsules plus oxaliplatin is superior to surgery alone;Capecitabine plus oxaliplatin is non-inferiority to Tegafur，Gimeracil and Oteracil Potassium Capsules plus oxaliplatin Stage II: Perioperative therapy * Perioperative Tegafur，Gimeracil and Oteracil Potassium Capsules plus oxaliplatin is superior to adjuvant Tegafur，Gimeracil and Oteracil Potassium Capsules plus oxaliplatin alone;Capecitabine plus oxaliplatin regimen is noninferiority to Tegafur,Gimeracil and Oteracil Potassium Capsules plus oxaliplatin * A regimen of Tegafur，Gimeracil and Oteracil Potassium Capsules plus oxaliplatin(SOX) and Capecitabine plus oxaliplatin(XELOX) improves survival among patients with incurable locally advanced or metastatic gastric cancer. The investigators assessed whether the addition of a perioperative regimen of SOX or XELOX regimen to adjuvant alone improves R0 resection rate and survival among patients with curable locally advanced gastric cancer.
Interventions
DRUGTegafur, Gimeracil and Oteracil Potassium Capsules；Oxaliplatin
Tegafur，Gimeracil and Oteracil Potassium Capsules 80 mg/m2 D1-D14 q3wk and Oxaliplatin 130 mg/m2 D1 q3wk for six cycles postoperation
Capecitabine,2000 mg/㎡ D1-D14 q3wk and Oxaliplatin,130 mg/㎡ D1 q3wk for two cycle pre-operation, Capecitabine,2000 mg/㎡ D1-D14 q3wk and Oxaliplatin,130 mg/m2 D1 q3wk for six cycles postoperation
Sponsors
Hebei Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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 criteria
* History of hypersensitivity to fluoropyrimidines, Tegafur，Gimeracil and Oteracil Potassium 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 normal range (ULN) (\>5.0 x ULN if hepatic metastasis); serum creatinine \> 1.2 mg/dL, and Ccr \> 60 ml/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 a reliable and appropriate contraceptive method. * Mental status is not fit for chemotherapy therapy presence of serious concomitant illness which might be aggravated by study medication: * Active cardiac disease e.g. decompensate myocardial infarction within the 6-month period preceding entry into the study. * History of ventricular arrhythmia or congestive heart failure. * Significant co-morbid medical conditions, including, but not limited to, Chronic obstructive pulmonary disease, interstitial pneumonia ,pulmonary fibrosis, heart failure, renal failure, hepatic failure, haemorrhagic peptic ulcer, mechanical or paralytic ileus, or poorly controlled diabetes.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease-free survival(DFS) | 3 year |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease control rate (DCR) | At the end of the study | To Assess disease control rate (DCR) as defined CR + PR + SD assessed by RECIST criteria |
| Down staging rate | Within 3 weeks after surgery | After the pathological examination of resected specimen |
| Objective response rate (ORR) | At the end of the study | — |
| Adverse events | Side effects during observation | Investigators graded all adverse events and toxic effects according to the National Cancer Institute's Common Toxicity Criteria, version 2.0. The number of Participants with adverse events will be recorded at each treatment visit. |
| R0-resection rate | Within 3 weeks after surgery | After the pathological examination of resected specimen |
| Overall survival (OS) | 5 year | — |
Countries
China
Outcome results
None listed