Perioperative Chemotherapy for Potentially Resectable Gastric Cancer

Gastric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01516944
• Other study ID #: TOTTG030103
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: February 2012
• Est. completion date: December 2018

Study information

• Verified date: February 2020
• Source: Hebei Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 749
• Est. completion date: December 2018
• Est. primary completion date: April 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Drug:
• Tegafur, 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
• Tegafur, Gimeracil and Oteracil Potassium Capsules;Oxaliplatin
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
• Oxaliplatin; Capecitabine
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

Locations

Country	Name	City	State
China	Department of General Surgery	Shijiazhuang	Hebei

Sponsors (1)

Lead Sponsor	Collaborator
Hebei Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease-free survival(DFS)		3 year
Secondary	Objective response rate (ORR)		At the end of the study
Secondary	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
Secondary	Down staging rate	After the pathological examination of resected specimen	Within 3 weeks after surgery
Secondary	Overall survival (OS)		5 year
Secondary	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
Secondary	R0-resection rate	After the pathological examination of resected specimen	Within 3 weeks after surgery