Gastric Cancer
Conditions
Keywords
gastric cancer, S-1, oxaliplatin, adjuvant chemotherapy
Brief summary
The purpose of this study is to assess the safety and efficacy of S-1 plus oxaliplatin combination chemotherapy based on the adverse events and survival period by performing a phase I/II study of this combination in patients with D2 resection of gastric cancer.
Detailed description
This stage I/II study is designed to evaluate the appropriate dose of S-1 plus fixed-dose of oxaliplatin (SOX regimen) for Patients with D2 resection of gastric cancer and survival of SOX regimen for stage II-III patients(AJCC 7th). To assess the efficacy, data on recurrence and survival will be collected from the time of enrollment until 3 years after surgery. To evaluate safety, data on adverse events will be collected from the time of enrollment until 1 year after surgery.
Interventions
DRUGs1
60-90mg/m2/d P.O. day 1-14, repeated every 21 days
DRUGOxaliplatin
130mg/m2 d1 repeated every 21 days
Sponsors
Chinese Academy of Medical Sciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* 20-70 years * Histologically proven adenocarcinoma of the stomach * Curative D2 lymphadenectomy resection for gastric cancer, who can start chemotherapy be within 6 weeks after surgery * Stage II, III (AJCC 7th edition) * Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 * No prior chemotherapy or radiotherapy * Adequate bone marrow, renal, and liver function
Exclusion criteria
* Any evidence of metastatic disease (including presence of tumor cells in the ascites). * Previous cytotoxic chemotherapy, radiotherapy or immunotherapy except corticosteroids, for the currently treated gastric cancer. * Major surgery within 4 weeks prior to study treatment start, or lack of complete recovery from the effects of major surgery. * Pregnant or lactating women. * History of another malignancy within the last five years except cured basal cell carcinoma of skin and cured carcinoma in-situ of uterine cervix. * Lack of physical integrity of the upper gastrointestinal tract or those who have malabsorption syndrome likely to influence absorption of capecitabine, or inability to take oral medication. * Organ allografts requiring immunosuppressive therapy. * Serious uncontrolled intercurrent infections or other serious uncontrolled concomitant disease. * Prior unanticipated severe reaction to fluoropyrimidine therapy (with or without documented dihydropyrimidine dehydrogenase (DPD) deficiency) or patients with known DPD deficiency. Hypersensitivity to platinum compounds or any of the components of the study medications. * Received any investigational drug or agent/procedure, i.e. participation in another trial, within 4 weeks before enter the trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| chemotherapy complete rate | 6 months | percentage of patients who completed eight cycles of chemotherapy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability | 3 years | assessed from surgery until 1 months after withdrawing from study |
| recurrence-free survival(RFS) | 3 years | from the date of surgery until the occurrence of an event (relapse or death whichever came first) |
| overall survival(OS) | 3 years | from the date of surgery to any cause of death |
Countries
China
Outcome results
None listed