Stomach Neoplasms
Conditions
Keywords
Stomach Neoplasms, drug therapy, oxaliplatin, s1
Brief summary
The purpose of this study is to determine the efficacy and safety of oxaliplatin and s1 as first-line treatment of advanced gastric cancer.
Detailed description
There was no evidence of standard chemotherapy for advanced gastric cancer (AGC) in China. Fluoropyrimidines and cisplatin have been widely used in a variety of combinations in the treatment of AGC. Capecitabine/cisplatin combination therapy showed an overall response rate (ORR) of 41- 55%, a median time to progression/progression free survival (TTP/PFS) of 5.6-6.3 months, and a median overall survival (OS) of 10.1-10.5 months. Though no studies have compared two oral fluoropyrimidines in combination with oxaliplatin, both S-1 and capecitabine appear to be comparable in terms of efficacy and safety. The investigators conducted a phase II trial of oxaliplatin combined with S-1 in the treatment of first-line AGC.
Interventions
DRUGOxaliplatin
130mg/m2 d1,repeated q21d
DRUGs1
80mg/m2/d, d1-14,repeated q21d
Sponsors
Chinese Academy of Medical Sciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically proven in operable advanced gastric adenocarcinoma (including adenocarcinoma of the gastrooesophageal junction) or relapse gastric adenocarcinoma * Measurable lesion and/or non-measurable lesion defined by RECIST * ECOG performance status ≦ 1 * Hgb ≧ 8g/dL, WBC 4000-12000/mm3, platelets ≧ 100,000/mm3 * Creatine ≦ upper normal limit (UNL) * Total bilirubin ≦ 1.5 X UNL * AST, ALT and ALP ≦ 2.5 x UNL * Subjects must be able to take orally * No prior chemotherapy * Life expectancy estimated than 3 months * Written informed consent
Exclusion criteria
* Pregnancy or lactation women, or women with suspected pregnancy or men with willing to get pregnant * Known brain metastases * History of hypersensitivity to fluoropyrimidines, oxaliplatin * Active double cancer * Treatment with any investigational product during the last 4 weeks prior to study entry * Symptomatic peripheral neuropathy ≧ garde 2. by NCI-CTCAE ver.3.0 * Any previous chemotherapy or radiotherapy for AGC
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression Free Survival | 2 years | from date of treatment was administered until the date of first documented progression or death from any cause whichever first, assessed every 6 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Response Rate | 2 years | From date of treatment was administered until the date of first documented response to treatment according to RECIST criteria,assessed every 2 cycles |
| overall survival | 2 years | From date of treatment was administered until the date of death from any cause,assessed every 3 months |
| number of participants with adverse events | 2 years | assessed from treatment was administered until 1 months after withdrawing from study |
Countries
China
Outcome results
None listed