Gastric Cancer
Conditions
Keywords
Gastric cancer, Adjuvant, Chemoradiotherapy, S-1, Cisplatin
Brief summary
This study was conducted to evaluate the clinical outcomes and toxicities of adjuvant treatment including S-1/cisplatin chemotherapy followed by S-1 based CRT.
Detailed description
Surgery is the only possible curative treatment of gastric cancer. However, the high recurrence rate makes gastric cancer a disease difficult to cure by surgery alone. Despite the benefit of CRT on local recurrence, the distant recurrence is the leading pattern of failure. We hypothesized that gastric cancer outcome could be improved using a more effective chemotherapy regimen. This study was conducted to evaluate the clinical outcomes and toxicity of adjuvant treatment including S-1/cisplatin chemotherapy followed by S-1 based CRT.
Interventions
DRUGS-1
Sponsors
Chonnam National University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \> 18 years * Histologically proven gastric adenocarcinoma which is complete resected * ECOG performance status of 1 or lower * Adequate bone marrow function * absolute neutrophil count \[ANC\] ≥1,500µL, and platelets ≥100,000/µL * Adequate kidney function (serum creatinine \< 1.5 mg/dL) * Adequate liver function (serum total bilirubin \< 2 times the upper normal limit (UNL) serum transaminases levels \<2 times UNL * No prior chemotherapy
Exclusion criteria
* Other tumor type than adenocarcinoma * Evidence of distant metastasis * Past or concurrent history of neoplasm except for curatively treated non-melanoma skin cancer or in situ carcinoma of the cervix uteri * Uncontrolled infection * Unstable cardiac disease despite treatment, myocardial infarction within months prior to study entry * History of significant neurologic or psychiatric disorders including dementia or seizures * Other serious underlying medical conditions which could impair the ability of the patient to participate in the study * Symptoms of gastrointestinal obstruction * concomitant drug medication: The following drugs cause drug interaction with S-1.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease free survival | 3 years |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival | 3 years |
| Number of participants with adverse events as a measure of safety and tolerability | 3 year |
Other
| Measure | Time frame |
|---|---|
| Health -related quality of life | 6 months after enrollment |
Countries
South Korea
Outcome results
None listed