Perioperative Chemotherapy for Potentially Resectable Gastric Cancer
Conditions
Gastric Cancer
Conditions: official terms
Stomach Neoplasms
Conditions: Keywords
Tegafur,Gimeracil and Oteracil Potassium Capsules, Capecitabine, Oxaliplatin, perioperative Chemotherapy, Gastric Cancer
Study Type
Interventional
Study Phase
Phase 2/Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Tegafur, Gimeracil and Oteracil Potassium Capsules;Oxaliplatin Type: Drug
Name: Tegafur, Gimeracil and Oteracil Potassium Capsules;Oxaliplatin Type: Drug
Name: Oxaliplatin; Capecitabine Type: Drug
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 75 Years
Minimum Age: 18 Years
Gender: Both
Criteria: 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.
Location
Department of General Surgery
Shijiazhuang, Hebei, China
Status: Recruiting
Contact: Qun Zhao, doctor - +8613930162111 - zhaoqun516@yahoo.com.cn
Start Date
February 2012
Completion Date
December 2018
Sponsors
Hebei Medical University
Source
Hebei Medical University
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page