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| ID | Type | Description | Link |
|---|---|---|---|
| KYUH-UHA-GC03-01 |
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RATIONALE: Drugs used in chemotherapy, such as S-1 and cisplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. Giving combination chemotherapy before surgery may shrink the tumor so that it can be removed.
PURPOSE: This phase II trial is studying how well giving S-1 together with cisplatin works in treating patients who are undergoing surgery for stage IV gastric cancer.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Patients receive oral S-1 on days 1-21 and cisplatin IV over 2 hours on day 8. Treatment repeats every 35 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients then undergo gastrectomy with lymphadenectomy. Patients resume oral S-1 after surgery.
PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cisplatin | Drug | |||
| tegafur-gimeracil-oteracil potassium | Drug | |||
| adjuvant therapy | Procedure | |||
| conventional surgery | Procedure | |||
| neoadjuvant therapy | Procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival |
| Measure | Description | Time Frame |
|---|---|---|
| Time to progression | ||
| Tumor response | ||
| Death related to treatment |
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DISEASE CHARACTERISTICS:
Histologically confirmed gastric adenocarcinoma
Stage IV disease meeting 1 of the following staging criteria according to Japanese gastric cancer classification:
CT scan and laparoscopic staging required
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
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| Name | Affiliation | Role |
|---|---|---|
| Seiji Satoh | Kyoto University Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kyoto University Hospital | Kyoto | Kyoto | 606-8507 | Japan | ||
| National Hospital Organization - Kyoto Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21667134 | Result | Satoh S, Okabe H, Teramukai S, Hasegawa S, Ozaki N, Ueda S, Tsuji A, Sakabayashi S, Fukushima M, Sakai Y. Phase II trial of combined treatment consisting of preoperative S-1 plus cisplatin followed by gastrectomy and postoperative S-1 for stage IV gastric cancer. Gastric Cancer. 2012 Jan;15(1):61-9. doi: 10.1007/s10120-011-0066-9. Epub 2011 Jun 11. |
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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 |
|---|---|
| D002945 | Cisplatin |
| D017024 | Chemotherapy, Adjuvant |
| D020360 | Neoadjuvant Therapy |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
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| Histological response |
| Postoperative complications |
| Surgical/pathological curative resection |
| Types of initial recurrence |
| Adverse events |
| Kyoto |
| Kyoto |
| 612-0861 |
| Japan |
| Kyoto-Katsura Hospital | Kyoto | Kyoto | 615-8256 | Japan |
| Kitano Hospital | Osaka | Osaka | 530-8480 | Japan |
| Kansai Denryoku Hospital | Osaka | Osaka | 553-0003 | Japan |
| Shimane Prefectural Central Hospital | Izumo-shi | Shimane | 693-0068 | Japan |
| Yamato Municipal Hospital | Yamato City Kanagawa | 242-8602 | Japan |
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D003131 |
| Combined Modality Therapy |
| D013812 | Therapeutics |
| D004358 | Drug Therapy |