Comparison Between XELOX and S1, Oxaliplatin and Docetaxel as Neoadjuvant Chemotherapy for Gastric Cancer
Phase 2 Study of Comparison Between XELOX (Capecitabine and Oxaliplatin) and Docetaxel, Oxaliplatin and S1 Regimen as Neoadjuvant Chemotherapy for Patients With Locally Advanced Gastric Cancer
1 other identifier
interventional
200
0 countries
N/A
Brief Summary
The choice of neoadjuvant chemotherapy regimen for locally advanced gastric cancer is controversial. The aim of this study was to compare the short- and long-term outcomes of XELOX regimen with Docetaxel, S1 and oxaliplatin regimen as neoadjuvant chemotherapy regimen for locally advanced gastric cancer. The objective of this study is to determine what kind of neoadjuvant chemotherapy strategy can make subsequent radical surgery feasible and improve overall survival in patients with locally advanced gastric cancer.
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 Jan 2016
Typical duration for phase_2 gastric-cancer
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 28, 2015
CompletedFirst Posted
Study publicly available on registry
December 7, 2015
CompletedStudy Start
First participant enrolled
January 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2019
CompletedDecember 7, 2015
December 1, 2015
1.9 years
November 28, 2015
December 4, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
response rate
through study completion, an average of 24 weeks
Secondary Outcomes (4)
R0 resection rate
through study completion, an average of 24 weeks
progression-free survival
through study completion, an average of 1 year
overall survival
through study completion, an average of 2 year
adverse events
through study completion, an average of 1 year
Study Arms (2)
capecitabine and oxaliplatin
ACTIVE COMPARATORcapecitabine of 1000 mg/m2, orally administered twice a day on days 1-14 and oxaliplatin at 130 mg/m2on day 1, as intravenous 2 h infusion
S1, oxaliplatin and docetaxel
EXPERIMENTALS1 of 40 mg/m2, orally administered twice a day on days 1-14,oxaliplatin 130 mg/m2 and docetaxel 40 mg/m2on day 1 as intravenous
Interventions
oxaliplatin 130 mg/m2
Eligibility Criteria
You may qualify if:
- patients with unresectable, histologically confirmed gastric adenocarcinoma with no distant metastases were eligible for the study.
You may not qualify if:
- peritoneal metastasis confirmed by CT scan
- lung metastasis, liver metastasis, pleural effusion, and/or other distant metastasis
- serious uncontrolled co-morbid conditions
- lacking of measurable target lesion
- any local intervention after initial diagnosis, such as surgical procedures, radiotherapy or trans-artery chemo-embolization
- patients who could not comprehend or comply with the study were also ineligible.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tianshu Liulead
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Chairman of the department of oncology
Study Record Dates
First Submitted
November 28, 2015
First Posted
December 7, 2015
Study Start
January 1, 2016
Primary Completion
December 1, 2017
Study Completion
December 1, 2019
Last Updated
December 7, 2015
Record last verified: 2015-12