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The purpose of this study is to determined the best definitive radiotherapy dosage for patients with locally advanced esophageal squamous cell carcinoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 50.4Gy | Active Comparator | Total radiotherapy dose of 50.4Gy. |
|
| 61.2Gy | Experimental | Total radiotherapy dose of 61.2Gy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiotherapy | Radiation | Different total radiotherapy dose between two arms. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival in PET/CT non-responders | The time between the start of the study treatment (Day 1) and death from any cause or last follow-up for patients alive at the end of the study. | 2 years |
| Overall survival in ITT population | The time between the start of the study treatment (Day 1) and death from any cause or last follow-up for patients alive at the end of the study. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Local control rate | The time between the start of the study treatment (Day 1) and local reccurence (included the primary tumor and regional lymph node failure) | 2 years |
| Progression-free survival |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jiangsu Cancer Hospital | Recruiting | Nanjing | Jiangsu | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35906623 | Derived | Zhu H, Liu Q, Xu H, Mo M, Wang Z, Lu K, Zhou J, Chen J, Zheng X, Ye J, Ge X, Luo H, Liu Q, Deng J, Ai D, Hao S, Zhang J, Tseng IH, Song S, Chen Y, Zhao K. Dose escalation based on 18F-FDG PET/CT response in definitive chemoradiotherapy of locally advanced esophageal squamous cell carcinoma: a phase III, open-label, randomized, controlled trial (ESO-Shanghai 12). Radiat Oncol. 2022 Jul 29;17(1):134. doi: 10.1186/s13014-022-02099-y. |
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| ID | Term |
|---|---|
| D000077277 | Esophageal Squamous Cell Carcinoma |
| D004938 | Esophageal Neoplasms |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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(defined as the time between Day 1 and the first event of local failure, metastatic recurrence, progression or death)
| 2 years |
| Overall survival in PET/CT responders | Overall survival in patients who have SUV ≤ 4 in PET/CT analysis in 25-28 radiotherapy fractions. | 2 years |
| Questionnaire EORTC-QLQ-C30 | A quality of life score is obtained according to the answers to the questionnaires. | 2 years |
| Questionnaire EORTC-QLQ-OES18 | A quality of life score is obtained according to the answers to the questionnaires. | 2 years |
| Huadong Hospital | Recruiting | Shanghai | Shanghai Municipality | 200000 | China |
|
| Fudan Universtiy Shanghai Cancer Center | Recruiting | Shanghai | Shanghai Municipality | 200032 | China |
|
| D009369 | Neoplasms |
| D018307 | Neoplasms, Squamous Cell |
| 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 |