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| Name | Class |
|---|---|
| Jiangsu Cancer Institute & Hospital | OTHER |
| First Affiliated Hospital of Zhejiang University | OTHER |
| The First Affiliated Hospital of Xiamen University | OTHER |
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The primary objective of this trial is to study whether paclitaxel plus 5-fluorouracil has better overall survival than cisplatin plus 5-fluorouracil in chemoradiotherapy for patients with locally advanced esophageal squamous cell carcinoma. 436 patients will be recruited into this study.
Locally advanced esophageal squamous cell carcinoma. T2-4N0-1M0-1a,TxN1M0-1a，TxNxM1a （according to AJCC2002）
Scheme:
Eligible recurrent patients with esophageal cancer will first be stratified by nodal staging (N0 or N1), then randomized to 2 arms at 1:1 ratio.
Arm Cisplatin:
Chemoradiotherapy with cisplatin and 5-fluorouracil for 4 cycles.
Arm Paclitaxel:
Chemoradiotherapy with weekly paclitaxel and 5-fluorouracil for 5 weeks followed by adjuvant chemotherapy for 2 cycles.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cisplatin | Active Comparator | Chemoradiotherapy with cisplatin and 5-fluorouracil for 2 cycles followed by adjuvant chemotherapy for 2 cycles. |
|
| Paclitaxel | Experimental | Patients randomized in Arm B will receive chemoradiation with weekly paclitaxel and 5-fluorouracil for 5 weeks followed by adjuvant chemotherapy with paclitaxel and 5-fluorouracil for 2 cycles. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paclitaxel plus 5-fluorouracil | Drug | 5-fluorouracil 300 mg/m2, d1-4, continuous infusion for 96 hours and paclitaxel 50 mg/m2 over 3 hours, d1 (week 1, week 2, week 3, week 4 and week 5); 5-fluorouracil 600 mg/m2/d d1-3 and paclitaxel 175 mg/m2 d1(week 9 and week 13). |
| Measure | Description | Time Frame |
|---|---|---|
| 3-yr overall survival | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Disease progression-free survival | 3 years | |
| Local progression-free survival | 3 years | |
| Number and grade of Participants with Adverse Events |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kuai Le Zhao, M.D. | Fudan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan University Cancer Center | Shanghai | Shanghai Municipality | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30920880 | Derived | Chen Y, Ye J, Zhu Z, Zhao W, Zhou J, Wu C, Tang H, Fan M, Li L, Lin Q, Xia Y, Li Y, Li J, Jia H, Lu S, Zhang Z, Zhao K. Comparing Paclitaxel Plus Fluorouracil Versus Cisplatin Plus Fluorouracil in Chemoradiotherapy for Locally Advanced Esophageal Squamous Cell Cancer: A Randomized, Multicenter, Phase III Clinical Trial. J Clin Oncol. 2019 Jul 10;37(20):1695-1703. doi: 10.1200/JCO.18.02122. Epub 2019 Mar 28. | |
| 29482649 |
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| Fujian Cancer Hospital |
| OTHER_GOV |
| Affiliated Hospital of Jiangnan University | OTHER |
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| Cisplatin plus 5-fluorouracil | Drug | cisplatin 25 mg/m2/d, d1-3, once every 4 weeks for 4 cycles (week 1, week 5, week 9 and week 13); 5-FU 600 mg/m2/d, d1-3, continuously infusion for 72 hrs,once every 4 weeks for 4 cycles (week 1, week 5, week 9 and week 13). |
|
| Radiation therapy | 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. |
|
| Radiation therapy | 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. |
|
| 6 months |
| Derived |
| Chen Y, Zhu Z, Zhao W, Li L, Ye J, Wu C, Tang H, Lin Q, Li J, Xia Y, Li Y, Zhou J, Zhao K. A randomized phase 3 trial comparing paclitaxel plus 5-fluorouracil versus cisplatin plus 5-fluorouracil in Chemoradiotherapy for locally advanced esophageal carcinoma-the ESO-shanghai 1 trial protocol. Radiat Oncol. 2018 Feb 27;13(1):33. doi: 10.1186/s13014-018-0979-0. |
| 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 |
|---|---|
| D017239 | Paclitaxel |
| D005472 | Fluorouracil |
| D002945 | Cisplatin |
| 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 |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D013812 | Therapeutics |
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