Status:
COMPLETED
Perioperative Chemotherapy for Potentially Resectable Gastric Cancer
Lead Sponsor:
Hebei Medical University
Conditions:
Gastric Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
PHASE3
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2018
Estimated Enrollment :
749 Patients enrolled
Trial Details
Trial ID
NCT01516944
Start Date
February 1 2012
End Date
December 1 2018
Last Update
February 13 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Department of General Surgery
Shijiazhuang, Hebei, China, 050011