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This randomized phase III trial is to compare simultaneous modulated accelerated boost with standard dose radiotherapy given together with chemotherapy in treating patients with esophageal squamous cell carcinoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SMART boost | Experimental | Radiotherapy with simultaneous modulated accelerated boost |
|
| Standard dose RT | Active Comparator | Standard dose radiotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiotherapy with simultaneous modulated accelerated boost | Radiation | Radiotherapy: 66Gy/30F to the gross tumor and 50Gy/25 to subclinical diseases |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Local-regional control | 2 years | |
| Distant metastasis-free survival | 2 years | |
| Disease-free survival |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chuangzhen Chen, MD | Cancer Hospital, Shantou University Medical College | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Hospital, Shantou University Medical College | Shantou | Guangdong | 515031 | China |
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| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| Standard dose radiotherapy | Radiation | Radiotherapy: 50Gy/25F to both gross tumor and subclinical disease |
|
| PF | Drug | Chemotherapy: Cisplatin and 5fluorouracil |
|
| 2 years after randomization |
| Acute and late toxicities using CTCAE v4.0 | The probabilities of grade ≥ 3 acute toxicities and 2-year late toxicities of esophagus and lungs. | 2 years |
| Quality of life as assessed with FACT-E | FACT-E score | 2 years |
| Quality of life as measured with EQ-5D | The score of EQ-5D questionnaire | 2 years |
| Biomarkers | 2 years |
| D006258 |
| Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |