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The current multicenter prospective phase II study aims to evaluate the safety and efficacy of preoperative FLOT therapy for esophageal squamous cell carcinoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FLOT therapy | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FLOT therapy | Drug | Preoperative FLOT therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Histological response rate (Grade 2 or 3 in Japanese Classification of Esophageal Cancer, 11th Edition) | 2.5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Response rate | 2.5 years | |
| Histological complete response rate | 2.5 years | |
| Treatment completion rate |
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Inclusion Criteria:
1) pT1a-LPM (M2) or deeper following EMR/ESD 2) pT1a-MM (M3) with vascular invasion following EMR/ ESD 8. No previous history of chemotherapy/radiotherapy/endocrine therapy except for hormone therapy for prostate cancer after 5 years interval 9. Patients who meet the following criteria
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Satoru Matsuda | Contact | +81333531211 | s.matsuda.a8@keio.jp |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Keio University Hospital | Recruiting | Tokyo | 1608582 | Japan |
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| ID | Term |
|---|---|
| D000077277 | Esophageal Squamous Cell Carcinoma |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| 2.5 years |
| Curative resection rate | 2.5 years |
| Recurrence free survival | 4.5 years |
| Overall survival | 4.5 years |
| Incidence rate of adverse event during FLOT | 2.5 years |
| Perioperative complication rate | 2.5 years |
| Late phase complication rate | 4.5 years |
| Incidence rate of severe adverse event | 2.5 years |
| Incidence rate of all adverse event | 4.5 years |
| D009369 | Neoplasms |
| D018307 | Neoplasms, Squamous Cell |
| D004938 | Esophageal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D006258 | Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |