Perioperative Chemotherapy for Potentially Resectable Gastric Cancer

This study is currently recruiting participants.
Verified October 2013 by Hebei Medical University
Sponsor:
Information provided by (Responsible Party):
Qun Zhao, Hebei Medical University
ClinicalTrials.gov Identifier:
NCT01516944
First received: January 10, 2012
Last updated: October 10, 2013
Last verified: October 2013

January 10, 2012
October 10, 2013
February 2012
December 2015   (final data collection date for primary outcome measure)
Disease-free survival(DFS) [ Time Frame: 3 year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01516944 on ClinicalTrials.gov Archive Site
  • Objective response rate (ORR) [ Time Frame: At the end of the study ] [ Designated as safety issue: No ]
  • Disease control rate (DCR) [ Time Frame: At the end of the study ] [ Designated as safety issue: No ]
    To Assess disease control rate (DCR) as defined CR + PR + SD assessed by RECIST criteria
  • Down staging rate [ Time Frame: Within 3 weeks after surgery ] [ Designated as safety issue: No ]
    After the pathological examination of resected specimen
  • Overall survival (OS) [ Time Frame: 5 year ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: Side effects during observation ] [ Designated as safety issue: Yes ]
    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.
  • R0-resection rate [ Time Frame: Within 3 weeks after surgery ] [ Designated as safety issue: No ]
    After the pathological examination of resected specimen
Same as current
Not Provided
Not Provided
 
Perioperative Chemotherapy for Potentially Resectable Gastric Cancer
Perioperative Tegafur Gimeracil Oteracil Potassium Capsule Plus Oxaliplatin Versus Capecitabine Plus Oxaliplatin in Patients With Localized Advanced Gastric Cancer

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.
Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Gastric Cancer
  • 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
    Other Names:
    • S-1
    • Oxaliplatin
  • Drug: 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
    Other Names:
    • S-1
    • Oxaliplatin
  • Drug: 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
    Other Names:
    • Oxaliplatin
    • Capecitabine
  • Active Comparator: postoperative chemotherapy,SOX
    Intervention: Drug: Tegafur, Gimeracil and Oteracil Potassium Capsules;Oxaliplatin
  • Experimental: Perioperative chemotherapy,SOX
    Intervention: Drug: Tegafur, Gimeracil and Oteracil Potassium Capsules;Oxaliplatin
  • Experimental: Perioperative chemotherapy,XELOX
    Intervention: Drug: Oxaliplatin; Capecitabine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
729
December 2018
December 2015   (final data collection date for primary outcome measure)

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 Stage III
  • 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.
Both
18 Years to 75 Years
No
Not Provided
China
 
NCT01516944
TOTTG030103
No
Qun Zhao, Hebei Medical University
Hebei Medical University
Not Provided
Principal Investigator: Qun Zhao, Doctor Hebei Medical University
Hebei Medical University
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP