Gastric Cancer
Conditions
Brief summary
This study is designed to compare the efficacy and safety of XELOX regimen with EOX regimen in the first-line treatment of advanced gastric cancer patients.
Detailed description
This study is designed to compare the efficacy and safety of XELOX regimen with EOX regimen in the first-line treatment of advanced gastric cancer patients.
Interventions
DRUGEpirubicin
50mg/m2 ivgtt d1
DRUGOxaliplatin
DRUGCapecitabine
1000mg/m2 po d1-14
Sponsors
Fudan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
Major inclusion criteria * had a histologically proven adenocarcinoma of the gastroesophageal junction, or stomach that was locally advanced (inoperable) or metastatic * measurable disease, according to the Response Evaluation Criteria in Solid Tumors (RECIST)1.1 * an Eastern Cooperative Oncology Group performance status of 0 to 2 * adequate renal, hepatic, and hematologic function Major
Exclusion criteria
* previous chemotherapy or radiotherapy (unless in the adjuvant setting) * uncontrolled cardiac disease, or other clinically significant, uncontrolled coexisting illness or previous or concurrent cancer * accumulated dose of Epirubicin exceeds 300mg/m2 * HER2 positive and willing to use trastuzumab
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression free survival | 7 months |
Secondary
| Measure | Time frame |
|---|---|
| overall survival | 10 months |
| overall response rate | 2 months |
| Number of Participants with Adverse Events | 2 months |
| quality of life questionnaire | 2 months |
Countries
China
Outcome results
None listed