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| Name | Class |
|---|---|
| Shanghai Chest Hospital | OTHER |
| Henan Cancer Hospital | OTHER_GOV |
| The First Affiliated Hospital with Nanjing Medical University | OTHER |
| First Affiliated Hospital of Chongqing Medical University |
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This is a Phase III clinical trail which Comparing Paclitaxel, Cisplatin Plus 5-FU (TCF) Versus Radiotherapy with Paclitaxel Plus Cisplatin (TC-RT) as Preoperative Therapy for Locally Advanced Esophageal Squamous Cancer. The Preoperative chemoradiotherapy with radical surgery is the standard treatment in China. But, many patients do not receive this treatment for many other reasons. Most of them refused or abandon radiotherapy because of the Intolerable adverse effects of radiotherapy, so we have launched a randomized controlled trial to confirm the non-inferiority of TCF over chemoradiotherapy with TC (TC-RT) as preoperative therapy for locally advanced esophageal squamous cancer in overall survival.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| "Paclitaxel, Cisplatin Plus 5-FU (TCF) | Experimental | preoperative chemotherapy with three cycles of TCF(Paclitaxel 135mg/m2 D1;Cisplatin 60mg/m2 D1 or 20mg/m2 D1-D3;5-fluorouracil 600mg/m2 D1-D5ï¼›repeated every 3 weeks |
|
| Preoperative radiochemotherapy | Experimental | preoperative radiochemotherapy (41.4 Gy/23 fractions or 40 Gy/20 fractions) with four cycles of TP(Paclitaxel 45mg/m2 on D1 and Cisplatin 20mg/m2 D1,repeated every week |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paclitaxel, Cisplatin Plus 5-FU (TCF) | Combination Product | preoperative chemotherapy with three cycles of TCF(Paclitaxel 135mg/m2 D1;Cisplatin 60mg/m2 D1 or 20mg/m2 D1-D3;5-fluorouracil 600mg/m2 D1-D5ï¼›repeated every 3 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Disease Free Survival | 3years | |
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | All participants with treatment-related adverse events as assessed by CTCAE v4.0 | through study completion, an average of 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yi Ba, MD,PHD | Contact | +8618622221230 | bayi@tjmuch.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| TianjinCIH | Tianjin | Tianjin Municipality | 300060 | China |
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| OTHER |
| The First Affiliated Hospital of Anhui Medical University | OTHER |
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| radiochemotherapy | Radiation | preoperative radiochemotherapy (41.4 Gy/23 fractions or 40 Gy/20 fractions) with four cycles of TP(Paclitaxel 45mg/m2 on D1 and Cisplatin 20mg/m2 D1,repeated every week) |
|
| Objective Response Rate | up to 24 weeks |
| Rate of R0 resection | up to 24 weeks |
| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| D017239 | Paclitaxel |
| D002945 | Cisplatin |
| D005472 | Fluorouracil |
| D059248 | Chemoradiotherapy |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
| D011878 | Radiotherapy |
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