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| ID | Type | Description | Link |
|---|---|---|---|
| CNUHH | Other Grant/Funding Number | Jeil Pham |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| S-1,chemoradiotherapy, adjuvant treatment | Experimental | Pts with radically D2 resected adenocarcinoma of the stomach or GEJ in AJCC stage Ib-IV (M0) were eligible for this study. Pts were treated with S-1 (40-60 mg depending on BSA) b.i.d. for 3 wks, and cisplatin (60 mg/m²) iv on day 1, followed by a 2-wk rest period, within a 5-wk cycle. Subsequently, radiotherapy (RT) started which consisted of 25 fractions of 1.8 Gy to a total dose of 45 Gy in 5 wks (5 fractions/wk). On RT days, S-1 (40-60 mg depending on BSA ) b.i.d., 5 days/wk was given. One month after the completion of RT, two 5-wk cycles of S-1/ciplatin chemotherapy were given. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| S-1 | Drug |
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| Measure | Description | Time Frame |
|---|---|---|
| Disease free survival | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | 3 years | |
| Number of participants with adverse events as a measure of safety and tolerability | 3 year |
| Measure | Description | Time Frame |
|---|---|---|
| Health -related quality of life | 6 months after enrollment |
Inclusion Criteria:
Age > 18 years
Histologically proven gastric adenocarcinoma which is complete resected
ECOG performance status of 1 or lower
Adequate bone marrow function
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:
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| Name | Affiliation | Role |
|---|---|---|
| Sang-Hee Cho, M.D.Ph.D. | CNUHH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chonnam National University Hwasun Hospital | Hwasun-Eup | Jeollanam-do | 519-809 | South Korea |
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| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C079198 | S 1 (combination) |
| C103828 | titanium silicide |
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| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |