Clinical trial NCT01516944: Perioperative Chemotherapy for Potentially Resectable Gastric Cancer
Official title: Perioperative Tegafur Gimeracil Oteracil Potassium Capsule Plus Oxaliplatin Versus Capecitabine Plus Oxaliplatin in Patients With Localized Advanced Gastric Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Gastric Cancer
Keywords: Tegafur，Gimeracil and Oteracil Potassium Capsules
Capecitabine
Oxaliplatin
perioperative Chemotherapy
Gastric Cancer
Lead sponsor: Hebei Medical University
Sponsor class: OTHER
First posted: 2012-01-25
Enrollment: 749
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Disease-free survival(DFS)
timeFrame: 3 year
Secondary outcomes:
measure: Objective response rate (ORR)
timeFrame: At the end of the study
measure: Disease control rate (DCR)
timeFrame: At the end of the study
measure: Down staging rate
timeFrame: Within 3 weeks after surgery
measure: Overall survival (OS)
timeFrame: 5 year
measure: Adverse events
timeFrame: Side effects during observation
measure: R0-resection rate
timeFrame: Within 3 weeks after surgery
Other outcomes:
Locations:
city: Shijiazhuang
country: China
facility: Department of General Surgery
state: Hebei
Study officials:
affiliation: Hebei Medical University
name: Qun Zhao, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zhao Q, Lian C, Huo Z, Li M, Liu Y, Fan L, Tan B, Zhao X, Zhang Z, Wang D, Liu Y, Guo H, Yang P, Tian Y, Li Y. The efficacy and safety of neoadjuvant chemotherapy on patients with advanced gastric cancer: A multicenter randomized clinical trial. Cancer Med. 2020 Aug;9(16):5731-5745. doi: 10.1002/cam4.3224. Epub 2020 Jun 24.