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| Name | Class |
|---|---|
| Taiho Pharmaceutical Co., Ltd. | INDUSTRY |
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The purpose of this study is to assess the safety and efficacy of S-1 and oxaliplatin combined with radiation by Phase I/II study.
The purpose of this study is as follows,
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| S-1 | Drug | 40mg/m2 orally twice a day (BID) for 5 days a week at 1st week, 2nd week, 4th week and 5th week. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Phase I: Determine the Recommended dose (RD) | Based on the incidence of dose-limited toxicities(DLT), the RD is determined from 4 test levels | 10 weeks |
| Phase II: pathological complete response rate | Pathological complete response(pCR) rate is calculated by numbers of pCR cases (grade 3) devided the number of subjected cases. | 12-16 week |
| Measure | Description | Time Frame |
|---|---|---|
| R0 resection rate | 12-16 weeks | |
| down staging rate | 12-16 weeks | |
| local reccurence rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Toshiaki Watanabe, M.D. | Tokyo University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nagoya University Graduate School of Medicine | Nagoya | 466-8550 | Japan | |||
| Osaka Medical College |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25612635 | Derived | Ishihara S, Matsusaka S, Kondo K, Horie H, Uehara K, Oguchi M, Murofushi K, Ueno M, Mizunuma N, Shinbo T, Kato D, Okuda J, Hashiguchi Y, Nakazawa M, Sunami E, Kawai K, Yamashita H, Okada T, Ishikawa Y, Nakajima T, Watanabe T. A phase I dose escalation study of oxaliplatin plus oral S-1 and pelvic radiation in patients with locally advanced rectal cancer (SHOGUN trial). Radiat Oncol. 2015 Jan 23;10:24. doi: 10.1186/s13014-015-0333-8. |
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| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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| ID | Term |
|---|---|
| C079198 | S 1 (combination) |
| D000077150 | Oxaliplatin |
| D011827 | Radiation |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D055585 | Physical Phenomena |
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| Oxaliplatin | Drug | 40-60mg/m2/week intravenously on day 1, 8, 22 and 29. |
|
| Radiation | Radiation | Total dose is 50.4Gy (1.8Gy X 28 fractions) |
|
| 3 years |
| desease free survuval | 3 years |
| safety | 16-20 weeks |
| Osaka |
| 569-8686 |
| Japan |
| Jichi Medical University Hospital | Tochigi | 329-0498 | Japan |
| Tokyo University | Tokyo | 113-0033 | Japan |
| Cancer Institute Hospital | Tokyo | 135-8550 | Japan |
| Teikyo University | Tokyo | 173-8606 | Japan |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |