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This primary objective of the trial is to study whether the local control of Huachansu plus thoracic radiotherapy is better compared to thoracic radiotherapy alone for patients with esophageal squamous cell carcinoma. It's a phase II study, 134 patients are expected to be recruited into the trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Huachansu Arm | Experimental | Patients in this arm will receive a treatment of Huachansu combined with thoracic radiotherapy. |
|
| Control Arm | Active Comparator | Patients in this arm will receive thoracic radiotherapy alone. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Huachansu | Drug | Huachansu 20 ml/m2/d, intervenous infusion, once a day, 5 times per week, during the period of radiation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Local control rate | The outcome measure will be assessed by every 3-month follow-up examinations. | the date of randomization until progression inside the irradiation field, up to 3 years. |
| Measure | Description | Time Frame |
|---|---|---|
| overall survival | The survival time from date of randomization to the day of death or the last follow-up. | the date of randomization until the death or the last follow up of the patients, up to 3 years. |
| progress-free survival |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan Universtiy Shanghai Cancer Center | Shanghai | Shanghai Municipality | 200032 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41021440 | Derived | Liu Q, Shen J, Chen Y, Zhou J, Luo H, Deng J, Ai D, Zhu H, Hao S, Zhao K. Phase II trial of radiotherapy plus Huachansu in elderly or chemotherapy-ineligible patients with locally advanced esophageal squamous cell carcinoma. Oncologist. 2025 Oct 1;30(10):oyaf325. doi: 10.1093/oncolo/oyaf325. |
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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 |
|---|---|
| C545813 | huachansu |
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| thoracic radiation | Radiation | A total dose of 61.2 Gy will be delivered in 34 fractions at 1.8 Gy/fraction, 5 fractions per week in 6.8 weeks. |
|
Measured from date of randomization until progression or death from any cause
| the date of randomization until progression or death from any cause, up to 3 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 |