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This study is conducted to investigate whether modified chemoradiotherapy with elective nodal irradiation reduces the locoregional recurrence that cannot be completely resected by salvage endoscopic resection and preserve esophagus without compromising overall survival.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chemoradiation therapy with elective nodal irradiation | Experimental | Chemoradiotherapy consists of 5-FU (1,000 mg / m2, day1-4, day29-32), CDDP (75 mg /m2, day1, 29) and radiotherapy (50.4 Gy/28Fr) |
|
| Chemoradiation therapy with involved field irradiation | Active Comparator | Chemoradiotherapy consists of 5-FU (700 mg /m2, day1-4, day29-32), CDDP (70 mg /m2, day1,29) and radiotherapy (60 Gy/30Fr) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chemoradiotherapy | Radiation | Chemoradiotherapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Major progression-free survival | If the remnant lesion in the esophagus or a recurrent lesion after complete response (CR) can be curatively removed by salvage EMR/ESD, it is not an event, and other progressions and deaths are events. | The primary analysis will be held 5-years after the last patient was enrolled. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | From date of randomization to date of death, approximately 5 years. | The primary analysis will be held 5-years after the last patient was enrolled. |
| Progression-free survival |
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Inclusion criteria:
Exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Motoo Nomura, MD/PhD | Contact | 81335422511 | mnomura@kuhp.kyoto-u.ac.jp |
| Name | Affiliation | Role |
|---|---|---|
| Ken Kato, MD/PhD | National Cancer Center Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Cancer Center Hospital | Recruiting | Tokyo | 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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| ID | Term |
|---|---|
| D059248 | Chemoradiotherapy |
| ID | Term |
|---|---|
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
| D011878 | Radiotherapy |
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From date of randomization to date of progression or death, whichever occurs first, approximately 5 years.
| The primary analysis will be held 5-years after the last patient was enrolled. |
| Complete response rate | CR was defined as disappeared primary tumors without the presence of ulceration or malignant cells in biopsy specimens under endoscopy. | The primary analysis will be held 5-years after the last patient was enrolled. |
| Esophagectomy-free survival | From date of randomization to date of esophagectomy or death, whichever occurs first, approximately 5 years. | The primary analysis will be held 5-years after the last patient was enrolled. |
| Adverse events | Number of participants with treatment-related adverse events during CRT as assessed by CTCAE v4.0 | The primary analysis will be held 5-years after the last patient was enrolled. |
| Long term toxicity | Number of participants with treatment-related adverse events after termination of CRT as assessed by CTCAE v4.0 | The primary analysis will be held 5-years after the last patient was enrolled. |
| 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 |