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| ID | Type | Description | Link |
|---|---|---|---|
| H-1204-103-407 | Other Identifier | SNUH IRB |
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| Name | Class |
|---|---|
| Clinical Research Center for Solid Tumor, Korea | OTHER |
This clinical trial is Phase II trial for evaluating efficacy of induction chemotherapy using Genexol-PM + cisplatin for locally advanced head and neck cancer. The investigators try to evaluate response rate of Genexol-PM + cisplatin chemotherapy, and safety profile.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| genexolPM + cisplatin | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| genexolPM + cisplatin | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| response rate | RECIST | every 2 cycles, 6wk later after chemotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| Locoregional control rate | NCI CTCAE | every 3wk (every cycle) |
| Quality of life | EORTC Q30; performance scale(activities) pain adverse event(appetite, sleep and so on) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Se-Hoon Lee, MD PhD | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | 110-744 | South Korea | |||
| Seoul National University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30796155 | Derived | Keam B, Lee KW, Lee SH, Kim JS, Kim JH, Wu HG, Eom KY, Kim S, Ahn SH, Chung EJ, Kwon SK, Jeong WJ, Jung YH, Kim JW, Heo DS. A Phase II Study of Genexol-PM and Cisplatin as Induction Chemotherapy in Locally Advanced Head and Neck Squamous Cell Carcinoma. Oncologist. 2019 Jun;24(6):751-e231. doi: 10.1634/theoncologist.2019-0070. Epub 2019 Feb 22. |
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| ID | Term |
|---|---|
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
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| every 3wk (every cycle) |
| safety | NCI CTCAE v3.0; disease or syndrome, pathologic funtion, sign or symptom, imjury or poisoning, anatomical abnormality, mental or behavioral dysfunction Neutropenia, leucopenia, thrombocytopenia, hepatotoxicity, renal toxicity | every 3wk (every cycle) |
| Seoul |
| South Korea |