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

October 17, 2023 updated by: Qun Zhao

Three Drugs in Advanced Gastric Cancer Neoadjuvant Chemotherapy for Stage Ⅲ Multicenter, Open, Randomized, Controlled Clinical Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

300

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Hebei
      • Shijiazhuang, Hebei, China, 050011
        • Fourth Affiliated Hospital of Hebei Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • 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 Names:
  • AIHENG,AIBIN

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The pathological complete response rate
Time Frame: 24 weeks
24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival(OS)
Time Frame: 3 years
3 years
Progression-free survival(PFS)
Time Frame: 3 years
3 years
Disease-free survival(DFS)
Time Frame: 3 years
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.
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Qun Zhao

Collaborators

Jiangsu HengRui Medicine Co., Ltd.

Investigators

  • Study Chair: Qun Zhao, director, The 4th Hospital of Hebei Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General 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)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2014

Primary Completion (Actual)

December 1, 2021

Study Completion (Actual)

June 1, 2022

Study Registration Dates

First Submitted

July 22, 2015

First Submitted That Met QC Criteria

September 18, 2015

First Posted (Estimated)

September 21, 2015

Study Record Updates

Last Update Posted (Actual)

October 19, 2023

Last Update Submitted That Met QC Criteria

October 17, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Alien Craft 0004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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