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The patient's study enrollment was too low.
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After curative resection, patients with stage IIIB-IV (M0) gastric cancer were given chemotherapy as follows: S-1 orally at 80 mg/m2 divided in two daily doses for 14 days and oxaliplatin at 130 mg/m2 intravenously over 2 h every 21 days as one cycle. S1 was administered for 16 cycles (12 months) and oxaliplatin for 8 cycles (6 months).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| S-1/Oxaliplatin | Experimental | S-1 80 mg/m²/day from day 1 to day 14, every 21 days, for 12 months; Oxaliplatin 130 mg/m² for day 1, every 21 days, for 6 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| S-1 (452500ACH) | Drug | S-1 80 mg/m²/day from day 1 to day 14, every 21 days, for 12 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| 3-year recurrence-free survival, RFS | 3-year |
| Measure | Description | Time Frame |
|---|---|---|
| 5-year overall survival, OS | 5-year |
| Measure | Description | Time Frame |
|---|---|---|
| Toxicity will be graded according to the CTCAE. | For patients who have experienced a dosing delay for starting treatment cycle, all assessments will be performed as scheduled. Reasons for dose modifications or delays, the supportive measures taken, and the outcome will be documented in the patient's chart and recorded in the CRF. | 1-year |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dong Hoe Koo, MD,PhD | Kangbuk Samsung Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kangbuk Samsung Hospital | Seoul | 110-746 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22010012 | Background | Sasako M, Sakuramoto S, Katai H, Kinoshita T, Furukawa H, Yamaguchi T, Nashimoto A, Fujii M, Nakajima T, Ohashi Y. Five-year outcomes of a randomized phase III trial comparing adjuvant chemotherapy with S-1 versus surgery alone in stage II or III gastric cancer. J Clin Oncol. 2011 Nov 20;29(33):4387-93. doi: 10.1200/JCO.2011.36.5908. Epub 2011 Oct 17. | |
| 22226517 |
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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 |
| C586502 | tegafur-gimeracil-oteracil |
| D000077150 | Oxaliplatin |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
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| OXALIPLATIN (205803BIJ) | Drug | Oxaliplatin 130 mg/m² for day 1, every 21 days, for 6 months |
|
|
| compliance for chemotherapy |
Accountability and subject compliance will be assessed by maintaining adequate dose of S1 and return records. Subjects will be asked to return all used and unused drug supply containers at the end of each cycle as a measure of compliance. The clinical administration records will be used to monitor compliance with oxaliplatin. |
| 1-year |
| Bang YJ, Kim YW, Yang HK, Chung HC, Park YK, Lee KH, Lee KW, Kim YH, Noh SI, Cho JY, Mok YJ, Kim YH, Ji J, Yeh TS, Button P, Sirzen F, Noh SH; CLASSIC trial investigators. Adjuvant capecitabine and oxaliplatin for gastric cancer after D2 gastrectomy (CLASSIC): a phase 3 open-label, randomised controlled trial. Lancet. 2012 Jan 28;379(9813):315-21. doi: 10.1016/S0140-6736(11)61873-4. Epub 2012 Jan 7. |
| 20734110 | Background | Lee SS, Jeung HC, Chung HC, Noh SH, Hyung WJ, Ahn JY, Rha SY. A pilot study of S-1 plus cisplatin versus 5-fluorouracil plus cisplatin for postoperative chemotherapy in histological stage IIIB-IV (M0) gastric cancer. Invest New Drugs. 2012 Feb;30(1):357-63. doi: 10.1007/s10637-010-9515-2. Epub 2010 Aug 24. |
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |