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| Name | Class |
|---|---|
| Huadong Hospital | OTHER |
| Wuxi No. 4 People's Hospital | OTHER |
| Jiangsu Cancer Institute & Hospital | OTHER |
| The First Affiliated Hospital of Xiamen University |
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The purpose of this study is to determined the best scheme in paclitaxel and cisplatin，paclitaxel and fluorouracil，paclitaxel and carboplatin concurrent with radiotherapy for patients with local advanced esophageal Squamous Cell Carcinoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Paclitaxel and Cisplatin (TP) | Active Comparator | Patients receive TP concurrent with radiotherapy (1.8Gy/d, d1-5/week, 34Fx) Paclitaxel: 175mg/m2/d, ivgtt over 3 hours, d1; Cisplatin: 25mg/m2/d, ivgtt, d1-3, q4w*4 |
|
| Paclitaxel and Fluorouracil (TF) | Active Comparator | Patients receive TF concurrent with radiotherapy(1.8Gy/d, d1-5/week, 34Fx) Concurrent: paclitaxel 50mg/m2/d, ivgtt over 3 hours, d1; 5-FU 300mg/m2, civ 96h, d1-4, qw*6; Adjuvant: paclitaxel 175 mg/m2/d, ivgtt over 3 hours, d1; 5-FU 1800mg/m2, civ 72h, d1-3, q4w*2 |
|
| Paclitaxel and Carboplatin（TC） | Active Comparator | Patients receive TC concurrent with radiotherapy(1.8Gy/d, d1-5/week, 34Fx) Concurrent: paclitaxel 50mg/m2/d, ivgtt over 3 hours, d1; carboplatin AUC=2, ivgtt, d1, qw*6; Adjuvant: paclitaxel 175 mg/m2/d, ivgtt over 3 hours, d1; carboplatin AUC=5, ivgtt, d1, q4w*2 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paclitaxel and Cisplatin | Drug | patients get Paclitaxel and Cisplatin according to protocol |
|
| Measure | Description | Time Frame |
|---|---|---|
| overall survival | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| progression free survival | 1year, 2 years, 3 years | |
| adverse event | 3 years |
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Inclusion criteria
To be eligible for this study, patient must fulfill all of the following criteria:
Histologically confirmed esophageal squamous cell carcinoma
Clinical stages II, III or IVa based on the 6th UICC-TNM classification
No prior treatment of chemotherapy, radiotherapy or surgery against esophageal cancer, except for non-curative resection by EMR/ESD.
Aged 18-75 years
Adequate organ functions
ECOG PS of 0-2
Life expectancy ≥3 months
Written informed consent
Exclusion criteria Patients fulfilling any of the following criteria are ineligible for this study.
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| Name | Affiliation | Role |
|---|---|---|
| Kuaile Zhao, MD | +86 18017312534 | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan University Cancer Hospital | Shanghai | Shanghai Municipality | 200032 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35188552 | Derived | Ai D, Ye J, Wei S, Li Y, Luo H, Cao J, Zhu Z, Zhao W, Lin Q, Yang H, Zheng X, Zhou J, Huang G, Li L, Li J, Zhang Z, Zhou G, Gu D, Du M, Mo M, Jia H, Zhang Z, Zhao K. Comparison of 3 Paclitaxel-Based Chemoradiotherapy Regimens for Patients With Locally Advanced Esophageal Squamous Cell Cancer: A Randomized Clinical Trial. JAMA Netw Open. 2022 Feb 1;5(2):e220120. doi: 10.1001/jamanetworkopen.2022.0120. | |
| 30344165 |
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| OTHER |
| Jiangxi Provincial Cancer Hospital | OTHER |
| Shanxi Province Cancer Hospital | OTHER |
| Gansu Cancer Hospital | OTHER |
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| Paclitaxel and Fluorouracil | Drug | patients get Paclitaxel and Fluorouracil according to protocol |
|
|
| Paclitaxel and Carboplatin | Drug | patients get Paclitaxel and Carboplatin according to protocol |
|
|
| Radiotherapy | Radiation | 1.8Gy/d, d1-5/week, 34Fx |
|
| Derived |
| Ai D, Chen Y, Liu Q, Zhang J, Deng J, Zhu H, Ren W, Zheng X, Li Y, Wei S, Ye J, Zhou J, Lin Q, Luo H, Cao J, Li J, Huang G, Wu K, Fan M, Yang H, Zhu Z, Zhao W, Li L, Fan J, Badakhshi H, Zhao K. Comparison of paclitaxel in combination with cisplatin (TP), carboplatin (TC) or fluorouracil (TF) concurrent with radiotherapy for patients with local advanced oesophageal squamous cell carcinoma: a three-arm phase III randomized trial (ESO-Shanghai 2). BMJ Open. 2018 Oct 21;8(10):e020785. doi: 10.1136/bmjopen-2017-020785. |
| 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 |
| 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 |
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| ID | Term |
|---|---|
| C111043 | TP protocol |
| D017239 | Paclitaxel |
| D005472 | Fluorouracil |
| D016190 | Carboplatin |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D056831 | Coordination Complexes |
| D013812 | Therapeutics |
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