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| Name | Class |
|---|---|
| Tianjin Medical University Cancer Institute and Hospital | OTHER |
| Cancer Institute and Hospital, Chinese Academy of Medical Sciences | OTHER |
| Fujian Cancer Hospital | OTHER_GOV |
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Cervical and upper thoracic esophageal cancer (ESCA) presents treatment challenges due to limited clinical evidence. This multi-center study (ChC&UES) explores radical radio(chemo)therapy efficacy and safety
Cervical and upper thoracic esophageal cancer (ESCA) are relatively rare diseases, presenting treatment challenges due to limited clinical evidence. This multi-center study (ChC&UES) explores radical radiotherapy efficacy and safety, especially focusing on radiation dose. This study collected all eligible patients diagnosed with cervical and upper thoracic ESCA from 6 medical centers (Tianjin Cancer Hospital, Cancer Hospital of the Chinese Academy of Medical Sciences, Fujian Cancer Hospital, Fudan University Shanghai Cancer Center, Shandong Cancer Hospital and the Fourth Hospital of Hebei Medical University) in China. Patients were categoried into two group (low dose radiation group and high dose radiation group) based on radiation dose. Basic clinical information, including age, gender, ECOG score, pathological type, smoking and drinking history, initial visit date, radiotherapy dose, radiotherapy method, concurrent chemotherapy modality, immunotherapy, targeted drug usage, treatment efficacy assessment, toxicity and side effects and survival time was collected. Kaplan-Meier method was used to calculate OS, survival differences were assessed using the log-rank test. Univariate analysis was conducted via Cox regression modeling, with variables demonstrating P values < 0.1 being included in multivariate analysis. A significance level of two-sided P < 0.05 was considered statistically significant. The aim of this study was to compared the overall survival time between low dose radiation group and high dose radiation dose group and compared the underlying side effects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High dose radiotherapy (≥60Gy) | Patients who received 60 Gy or more than 60Gy radiation dose for radical radiation therapy for the primary tumor. | ||
| Low dose radiotherapy (50-<60Gy) | Patients who received 50-<60Gy radiation dose for radical radiation therapy for the primary tumor. |
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| Measure | Description | Time Frame |
|---|---|---|
| Overall survival time (OS) | Compared the differences in overall survival (OS) between low dose radiation and high dose radiation group after definitive radiotherapy. OS is defined as time from start of enrollment to death from any cause. | 2000.1.1-2024.6.20 |
| progression-free survival (PFS) | Progression-free survival (PFS) is defined as the time from the start of enrollment until tumor progression or death from any cause. | 2000.1.1-2024.6.20 |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) | The Objective Response Rate (ORR) is assessed by the investigator using the Solid Tumor Remission Assessment Criteria (RECIST 1.1 criteria). Measures the effectiveness of a cancer treatment by showing the percentage of patients whose tumors shrink significantly within a specified time. ORR includes: Complete Response (CR): All target tumors disappear, and no new tumors appear.Partial Response (PR): The size of target tumors decreases by at least 30%, and no new tumors appear. The proportion of patients who achieve CR+PR was ORR. |
| Measure | Description | Time Frame |
|---|---|---|
| Side effect | The investigators employed the National Cancer Institute's (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 5.0, to assess treatment-related adverse effects during and after the course of treatmen | 2000.1.1-2024.6.20 |
Inclusion Criteria:
Exclusion Criteria:
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This study is a real-world study. All esophageal cancer patients over 18 years old who received radical radiotherapy in cervical and upper thoracic segment eligible for inclusion were retrospectively collected. This study is a reflection of real-world, no restriction on treatment was made.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wenbin Shen | Contact | +86 15831183879 | wbshen2024@hebmu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Wenbin Shen | Hebei Medical University Fourth Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Because this study is a response to real-world patient treatment and outcomes | Recruiting | Shijiazhuang | Hebei | 050000 | 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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| Fudan University |
| OTHER |
| Shandong Cancer Hospital and Institute | OTHER |
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| 2000.1.1-2024.6.20 |
| D006258 |
| Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |