Three Drugs in Advanced Gastric Cancer Neoadjuvant Chemotherapy for Stage Ⅲ Clinical Study
1 other identifier
interventional
300
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 gastric-cancer
Started Nov 2014
Longer than P75 for phase_2 gastric-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2014
CompletedFirst Submitted
Initial submission to the registry
July 22, 2015
CompletedFirst Posted
Study publicly available on registry
September 21, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2022
CompletedOctober 19, 2023
October 1, 2023
7.1 years
July 22, 2015
October 17, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The pathological complete response rate
24 weeks
Secondary Outcomes (4)
Overall survival(OS)
3 years
Progression-free survival(PFS)
3 years
Disease-free survival(DFS)
3 years
Adverse events
3 years
Study Arms (3)
A（DOX）
EXPERIMENTALInterventions：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
B（Xelox）
ACTIVE COMPARATORInterventions：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
C（Xelox）
ACTIVE COMPARATORInterventions：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.
Interventions
docetaxel 60mg/m2， ivgtt，2h，d1;capecitabine 1000mg/m2 po bid d1-14; oxaliplatin 130mg/m2， ivgtt，2h，d1;q21d
oxaliplatin 130mg/m2， ivgtt，2h，d1;capecitabine 1000mg/m2 po bid d1-14;q21d
Eligibility Criteria
You may qualify if:
- 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;
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Qun Zhaolead
- Jiangsu HengRui Medicine Co., Ltd.collaborator
Study Sites (1)
Fourth Affiliated Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050011, China
Related Publications (2)
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)
RESULTTian Y, Yang P, Guo H, Liu Y, Zhang Z, Ding P, Zheng T, Deng H, Ma W, Li Y, Fan L, Zhang Z, Wang D, Zhao X, Tan B, Liu Y, Zhao Q. Neoadjuvant docetaxel, oxaliplatin plus capecitabine versus oxaliplatin plus capecitabine for patients with locally advanced gastric adenocarcinoma: long-term results of a phase III randomized controlled trial. Int J Surg. 2023 Dec 1;109(12):4000-4008. doi: 10.1097/JS9.0000000000000692.
PMID: 37678277DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Qun Zhao, director
The 4th Hospital of Hebei Medical University
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Surgical director
Study Record Dates
First Submitted
July 22, 2015
First Posted
September 21, 2015
Study Start
November 1, 2014
Primary Completion
December 1, 2021
Study Completion
June 1, 2022
Last Updated
October 19, 2023
Record last verified: 2023-10