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Three Drugs in Advanced Gastric Cancer Neoadjuvant Chemotherapy for Stage Ⅲ Clinical Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02555358
Recruitment Status : Recruiting
First Posted : September 21, 2015
Last Update Posted : February 13, 2020
Sponsor:
Collaborator:
Jiangsu HengRui Medicine Co., Ltd.
Information provided by (Responsible Party):
Qun Zhao, Hebei Medical University

Tracking Information
First Submitted Date  ICMJE July 22, 2015
First Posted Date  ICMJE September 21, 2015
Last Update Posted Date February 13, 2020
Study Start Date  ICMJE November 2014
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 18, 2015)
The pathological complete response rate [ Time Frame: 24 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 18, 2015)
  • Overall survival(OS) [ Time Frame: 3 years ]
  • Progression-free survival(PFS) [ Time Frame: 3 years ]
  • Disease-free survival(DFS) [ Time Frame: 3 years ]
  • Adverse events [ Time Frame: 3 years ]
    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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Three Drugs in Advanced Gastric Cancer Neoadjuvant Chemotherapy for Stage Ⅲ Clinical Study
Official Title  ICMJE Three Drugs in Advanced Gastric Cancer Neoadjuvant Chemotherapy for Stage Ⅲ Multicenter, Open, Randomized, Controlled Clinical Study
Brief Summary The purpose of this study is to assess the relationship of pCR rate and efficacy by comparing the two drugs and three drugs as neoadjuvant chemotherapy in advanced gastric cancer patients.
Detailed Description Eligible patients will be randomly assigned by a randomisation system in a 1:1:1 ratio to three group. The group A wil receive four cycles of DOX (docetaxel 60mg/m2 on day 1,oxaliplatin 130mg/m2 on day 1 and capecitabine 1,000 mg/m2 per day on days 1 to 14, repeated every 3 weeks) as neoadjuvant therapy and four cycles of Xelox (capecitabine 1,000 mg/m2 per day on days 1 to 14 and oxaliplatin 130mg/m2 on day 1, repeated every 3 weeks) as adjuvant therapy.The group B wil receive four cycles of Xelox (capecitabine 1,000 mg/m2 per day on days 1 to 14 and oxaliplatin 130mg/m2 on day 1, repeated every 3 weeks) as neoadjuvant therapy and four cycles of Xelox as adjuvant therapy.The group C wil receive eight cycles of Xelox (capecitabine 1,000 mg/m2 per day on days 1 to 14 and oxaliplatin 130mg/m2 on day 1, repeated every 3 weeks) as adjuvant therapy.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Gastric Cancer
Intervention  ICMJE
  • Drug: docetaxel,0xaliplatin,capecitabine
    docetaxel 60mg/m2, ivgtt,2h,d1;capecitabine 1000mg/m2 po bid d1-14; oxaliplatin 130mg/m2, ivgtt,2h,d1;q21d
    Other Name: AISU,AIHENG,AIBIN
  • Drug: oxaliplatin,capecitabine
    oxaliplatin 130mg/m2, ivgtt,2h,d1;capecitabine 1000mg/m2 po bid d1-14;q21d
    Other Name: AIHENG,AIBIN
Study Arms  ICMJE
  • Experimental: A(DOX)
    Interventions:This arm wil receive four cycles of DOX (docetaxel 60mg/m2 on day 1,oxaliplatin 130mg/m2 on day 1 and capecitabine 1,000 mg/m2 per day on days 1 to 14, repeated every 3 weeks) as neoadjuvant therapy and four cycles of Xelox (capecitabine 1,000 mg/m2 per day on days 1 to 14 and oxaliplatin 130mg/m2 on day 1, repeated every 3 weeks) as adjuvant therapy
    Intervention: Drug: docetaxel,0xaliplatin,capecitabine
  • Active Comparator: B(Xelox)
    Interventions:This arm wil receive four cycles of Xelox (capecitabine 1,000 mg/m2 per day on days 1 to 14 and oxaliplatin 130mg/m2 on day 1, repeated every 3 weeks) as neoadjuvant therapy and four cycles of Xelox as adjuvant therapy
    Intervention: Drug: oxaliplatin,capecitabine
  • Active Comparator: C(Xelox)
    Interventions:This arm wil receive eight cycles of Xelox (capecitabine 1,000 mg/m2 per day on days 1 to 14 and oxaliplatin 130mg/m2 on day 1, repeated every 3 weeks) as adjuvant therapy.
    Intervention: Drug: oxaliplatin,capecitabine
Publications * 1. Zhao Q, Li Y, Tan BB, Tian Y, Jiao ZK, Zhao XF, Zhang ZD, Wang D, Yang PG. XELOX neoadjuvant chemotherapy for advanced gastric cancer resection rate and the impact on prognosis. Journal of Cancer 2013,35 (10) : 773-777 2. Zhao Q, Li Y, Wang GY, Jiao ZK, Zhao XF, Zhang ZD, Tan BB, Zhou CX, Sun WL laparoscopic abdominal control study of gastric cancer resection surgery clinical effect. Chinese General Practice, 2013,16 (1B): 210-215. 3.Zhao Q, Li Y, Tian Y, Chen YN, Tan BB, Zhao XF, Jiao ZK, Zhang ZD, Chang SL. Histological Complete Response after Neoadjuvant XELOX in Advanced Gastric Carcinoma. Hepatogastroenterology. 2013 Jan 24;60(126)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 18, 2015)
300
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2023
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Histologically or cytologically proven in operable advanced gastric adenocarcinoma;
  2. Subjects who were identified as potentially resectable cases by a multidisciplinary consultation;
  3. KPS> 80; ECOG score: 0-1;
  4. Expected survival> 6 months;
  5. Age 20 -60;
  6. Major organ function has to meet the following criteria:

    Neutrophil count ≥1.5 × 109 / L, platelet count ≥100 × 109 / L, Hemoglobin ≥90g / L, liver function <1.5 times the upper limit of normal, serum bilirubin ≤1.0 × UNL, serum creatinine <1.5 × UNL, PT-INR / PTT <1.7 times the upper limit of normal;

  7. Subjects has to voluntarily join the study and sign the Informed Consent Form for the study;

Exclusion Criteria:

  1. Associated with serious diseases in liver ,kidney, cardiovascular system and other vital organs;
  2. History of hypersensitivity to docetaxel, capecitabine, oxaliplatin or the ingredients of this product;
  3. Receiving any form of chemotherapy or other study medication;
  4. Pregnancy or lactation women, or women with suspected pregnancy or men unless using a reliable and appropriate contraceptive method;
  5. Associated with inability to swallow, haemorrhagic peptic ulcer, mechanical or paralytic ileus, gastrointestinal active bleeding.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Qun Zhao, director 13930162111 ext 0311-86095588 zhaoqun516@126.com
Contact: Yuan Tian 18531117658 ext 0311-86095588 tangy0767@163.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02555358
Other Study ID Numbers  ICMJE Alien Craft 0004
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Qun Zhao, Hebei Medical University
Study Sponsor  ICMJE Qun Zhao
Collaborators  ICMJE Jiangsu HengRui Medicine Co., Ltd.
Investigators  ICMJE
Study Chair: Qun Zhao, director The 4th Hospital of Hebei Medical University
PRS Account Hebei Medical University
Verification Date February 2020

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