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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

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.

Condition or disease Intervention/treatment Phase
Gastric Cancer Drug: docetaxel,0xaliplatin,capecitabine Drug: oxaliplatin,capecitabine Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Three Drugs in Advanced Gastric Cancer Neoadjuvant Chemotherapy for Stage Ⅲ Multicenter, Open, Randomized, Controlled Clinical Study
Study Start Date : November 2014
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

Arm Intervention/treatment
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
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

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
Drug: oxaliplatin,capecitabine
oxaliplatin 130mg/m2, ivgtt,2h,d1;capecitabine 1000mg/m2 po bid d1-14;q21d
Other Name: AIHENG,AIBIN

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.
Drug: oxaliplatin,capecitabine
oxaliplatin 130mg/m2, ivgtt,2h,d1;capecitabine 1000mg/m2 po bid d1-14;q21d
Other Name: AIHENG,AIBIN




Primary Outcome Measures :
  1. The pathological complete response rate [ Time Frame: 24 weeks ]

Secondary Outcome Measures :
  1. Overall survival(OS) [ Time Frame: 3 years ]
  2. Progression-free survival(PFS) [ Time Frame: 3 years ]
  3. Disease-free survival(DFS) [ Time Frame: 3 years ]
  4. 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.



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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02555358


Contacts
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Contact: Qun Zhao, director 13930162111 ext 0311-86095588 zhaoqun516@126.com
Contact: Yuan Tian 18531117658 ext 0311-86095588 tangy0767@163.com

Locations
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China, Hebei
Fourth Affiliated Hospital of Hebei Medical University Recruiting
Shijiazhuang, Hebei, China, 050011
Contact: Qun Zhao, doctor    13930162111    zhaoqun516@126.com   
Sponsors and Collaborators
Qun Zhao
Jiangsu HengRui Medicine Co., Ltd.
Investigators
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Study Chair: Qun Zhao, director The 4th Hospital of Hebei Medical University
Publications of Results:
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)

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Responsible Party: Qun Zhao, Surgical director, Hebei Medical University
ClinicalTrials.gov Identifier: NCT02555358    
Other Study ID Numbers: Alien Craft 0004
First Posted: September 21, 2015    Key Record Dates
Last Update Posted: February 13, 2020
Last Verified: February 2020
Keywords provided by Qun Zhao, Hebei Medical University:
Resectable advanced gastric cancer
Additional relevant MeSH terms:
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Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Docetaxel
Capecitabine
Oxaliplatin
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites