Perioperative Chemotherapy for Potentially Resectable Gastric Cancer

Study Overview
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Brief Summary
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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.

Official Title
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Perioperative Tegafur Gimeracil Oteracil Potassium Capsule Plus Oxaliplatin Versus Capecitabine Plus Oxaliplatin in Patients With Localized Advanced Gastric Cancer

Conditions
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Gastric Cancer

Intervention / Treatment
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* Drug: Tegafur, Gimeracil and Oteracil Potassium Capsules；Oxaliplatin
* Drug: Tegafur, Gimeracil and Oteracil Potassium Capsules；Oxaliplatin
* Drug: Oxaliplatin; Capecitabine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: postoperative chemotherapy,SOX<br> | Drug: Tegafur, Gimeracil and Oteracil Potassium Capsules；Oxaliplatin<br>* Tegafur，Gimeracil and Oteracil Potassium Capsules 80 mg/m2 D1-D14 q3wk and Oxaliplatin 130 mg/m2 D1 q3wk for six cycles postoperation<br>* Other names: Oxaliplatin;|
| Experimental: Perioperative chemotherapy,SOX<br> | Drug: Tegafur, Gimeracil and Oteracil Potassium Capsules；Oxaliplatin<br>* Tegafur，Gimeracil and Oteracil Potassium Capsules 80mg/㎡ ,D1-D14 q3wk and Oxaliplatin,130 mg/㎡ D1 q3wk for two cycles preoperation, Tegafur，Gimeracil and Oteracil Potassium Capsules ,80 mg/㎡ D1-D14 q3wk and Oxaliplatin,130 mg/㎡ D1 q3wk for six cycles postoperation<br>* Other names: Oxaliplatin;|
| Experimental: Perioperative chemotherapy,XELOX<br> | Drug: Oxaliplatin; Capecitabine<br>* 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<br>* Other names: Capecitabine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease-free survival(DFS) |  | 3 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rate (ORR) |  | At the end of the study | 
| Disease control rate (DCR) | To Assess disease control rate (DCR) as defined CR + PR + SD assessed by RECIST criteria | At the end of the study | 
| Down staging rate | After the pathological examination of resected specimen | Within 3 weeks after surgery | 
| Overall survival (OS) |  | 5 year | 
| Adverse events | 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. | Side effects during observation | 
| R0-resection rate | After the pathological examination of resected specimen | Within 3 weeks after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tegafur，Gimeracil and Oteracil Potassium Capsules, Capecitabine, Oxaliplatin, perioperative Chemotherapy, Gastric Cancer