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| Name | Class |
|---|---|
| Jeil Pharmaceutical Co., Ltd. | INDUSTRY |
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This study will conduct a phase II study of triple combination with oxaliplatin, irinotecan, and S-1 as the first-line chemotherapy in patients with advanced gastric cancer.
It is widely accepted that the efficacy of chemotherapy for patients with inoperable, advanced, and metastatic gastric cancer is better than that compared to best supportive care. In general, combination chemotherapies are more efficient than monotherapy and so it is reasonable to give combination chemotherapy to patients with good performance status.
Especially dual combination chemotherapy with fluoropyrimidine and platinum has shown the objective response rate of 25-48% in patients with newly diagnosed advanced metastatic gastric cancer and several studies about triple combination with oxaliplatin, irinotecan, and fluoropyrimidine have shown the response rate of 53~75% but also higher rate of hematologic adverse events. So the investigators had conducted the phase I study of these three drugs with modification of dosage and schedule and will conduct a phase II study with recommended dose of triple chemotherapy from this phase I study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oxaliplatin, Irinotecan, S-1(OIS) | Experimental | triple combination with oxaliplatin, irinotecan, and S-1. Treatment will be delivered as a 2-week cycle.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxaliplatin, Irinotecan, S-1(OIS) | Drug | Treatment will be delivered every 2 weeks
|
| Measure | Description | Time Frame |
|---|---|---|
| overall response rate | Tumor response will be classified on the basis of the response evaluation criteria in solid tumors (RECIST) guidelines version 1.1 | 1.5 years |
| Measure | Description | Time Frame |
|---|---|---|
| progression free survival | The progression-free survival (PFS) will be measured from the start of study treatment until documented tumor progression (by RECIST) or death due to any cause | 1.5 years |
| overall survival |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dae Young Zang, MD, PhD | Hallym University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hallym university medical center | Anyang | Gyunggi | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29372461 | Derived | Kim HS, Ryu MH, Zang DY, Park SR, Han B, Kang WK, Rha SY, Jung M, Kim JS, Kang BW, Lee KH, Rho SY, Kim JH, Kim KC, Cho JW, Choi DR, Lim H, Kang HS, Soh JS, Kim MJ, Seo J, Kang YK. Phase II study of oxaliplatin, irinotecan and S-1 therapy in patients with advanced gastric cancer: the Korean Cancer Study Group ST14-11. Gastric Cancer. 2018 Sep;21(5):802-810. doi: 10.1007/s10120-018-0794-1. Epub 2018 Jan 25. |
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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 |
|---|---|
| D000077150 | Oxaliplatin |
| D000077146 | Irinotecan |
| C079198 | S 1 (combination) |
| C103828 | titanium silicide |
| D005641 | Tegafur |
| C104201 | gimeracil |
| D010094 | Oxonic Acid |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D002166 | Camptothecin |
| D000470 | Alkaloids |
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|
The overall survival (OS) will be estimated from the start of study treatment until participant's death and measured using the Kaplan-Meier method
| 1.5 years |
| Toxicity profiles - The number of participants and grade of intensity of treatment related adverse events | adverse events will be graded using the NCI common terminology criteria for adverse events (NCTCAE) v 4.0 | 1.5 years |
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D006571 |
| Heterocyclic Compounds |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D014227 | Triazines |