Recurrent, Stage IV, Stomach Neoplasm
Conditions
Brief summary
To evaluate the efficacy and safety of weekly administered combination of docetaxel/cisplatin and docetaxel/oxaliplatin in chemotherapy-naïve patients with advanced gastric cancer. The primary endpoint will be the response rate.
Detailed description
Gastric cancer is the most frequently occurring malignancy in Korea, and is one of the main causes of cancer death. While treatment options for AGC have expanded in recent years to include newer agents such as taxanes, irinotecan and oxaliplatin, myelosuppression remains a problem. Recently, weekly schedule of docetaxel is appealing due to limited incidence of severe myelosuppression compared with standard 3-weekly regimen. This altered toxicity profile suggests a potential for better tolerance and increased dose intensity.
Interventions
DRUGoxaliplatin
oxaliplatin 120 mg/m2 will be given on day 1.
DRUGCisplatin
Cisplatin 60 mg/m2 will be given on day 1.
Sponsors
Sanofi
Gachon University Gil Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* histologically proven gastric cancer * aged 75 years or less * performance status 0 to 2 * no prior chemotherapy * inoperable, recurrent, or metastatic * normal marrow, hepatic and renal functions
Exclusion criteria
* active infections * severe co-morbidities * pregnant or lactating women * active brain metastasis * neuropathy of grade 2 or higher
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| safety | — |
Countries
South Korea
Contacts
Primary ContactDong Bok Shin, MD, PhD
Outcome results
None listed