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Completed

NCT Number: NCT02555358

Three Drugs in Advanced Gastric Cancer Neoadjuvant Chemotherapy for Stage Ⅲ 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.

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Key information

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Fourth Affiliated Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050011, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Histologically or cytologically proven in operable advanced gastric adenocarcinoma;
  • Subjects who were identified as potentially resectable cases by a multidisciplinary consultation;
  • KPS> 80; ECOG score: 0-1;
  • Expected survival> 6 months;
  • Age 20 -60;
  • 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;

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

Exclusion criteria

  • Associated with serious diseases in liver ,kidney, cardiovascular system and other vital organs;
  • History of hypersensitivity to docetaxel, capecitabine, oxaliplatin or the ingredients of this product;
  • Receiving any form of chemotherapy or other study medication;
  • Pregnancy or lactation women, or women with suspected pregnancy or men unless using a reliable and appropriate contraceptive method;
  • Associated with inability to swallow, haemorrhagic peptic ulcer, mechanical or paralytic ileus, gastrointestinal active bleeding.

Treatment and study plan

docetaxel,0xaliplatin,capecitabine

Drug

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

oxaliplatin,capecitabine

Drug

oxaliplatin 130mg/m2, ivgtt,2h,d1;capecitabine 1000mg/m2 po bid d1-14;q21d

Other names: AIHENG,AIBIN

Primary outcomes

  1. The pathological complete response rate

    Time frame: 24 weeks

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Qun Zhao

Other

Collaborators

  • Jiangsu HengRui Medicine Co., Ltd.

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2021
Study completion
2022
First posted
Sep 21, 2015
Registry last updated
Oct 19, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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