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Definitive chemoradiotherapy with cisplatin with cisplatin plus 5-fluorouracil is the standard in Western countries in esophagus cancer.But in China because of its toxic reaction, most of patients stop the halfway.Because low toxicity, Capecitabine is widely used in the chemotherapy of esophageal cancer.
The purpose of this experiment was to study the different cycle on capecitabine with chemotherapy for esophageal cancer chemoradiation effect.We are prepared to within 2 years study recruited 200 patients with esophageal cancer.The primary endpoint is overall survival and the secondary endpoints include progression-free survival, response rate,pathologic complete response rate and adverse events.
We recruited the patients who were pathologically confirmed with esophageal squamous cell carcinoma from the Oct 2014. The the patients was divided into two groups. Group 1: Capecitabine + chemoradiation, radiation at the end of the stop using capecitabine. Group 2: Capecitabine + chemoradiation, at the end of the radiotherapy with capecitabine consolidating treatment for 5 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Capecitabine-5 weeks-radiotherapy | Experimental | Capecitabine 5 weeks : 625mg/m2, bid d1-5; q1w, po,5 weeks in total, radiotherapy: 50Gy ,2 Gy/d,5d/w. |
|
| Capecitabine-10 weeks-radiotherapy | Active Comparator | Capecitabine 10 weeks : 625mg/m2, bid d1-5; q1w, po,10 weeks in total, radiotherapy: 50Gy ,2 Gy/d,5d/w. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Capecitabine(Aibin) | Drug | Capecitabine(Aibin):625mg/m2, bid d1-5; q1w, po,5 or 10 weeks in total |
|
| Measure | Description | Time Frame |
|---|---|---|
| overall survival, OS | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| progression-free survival | 2 years | |
| overall remission rate, ORR | 16 weeks | |
| serious adverse event |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shegan Gao, Doctor | Contact | 18638859977 | gsg112258@163.com | |
| Tanyou Shan, Master | Contact | 18537976669 | shantanyou@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Shegan Gao, Doctor | The First Affiliated Hospital of Henan University of Science and Technology | Study Chair |
| Tanyou Shan, Master | The First Affiliated Hospital of Henan University of Science and Technology | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Henan University of Science and Technology | Recruiting | Luoyang | Henan | 471003 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20888705 | Background | Park JW, Kim JH, Choi EK, Lee SW, Yoon SM, Song SY, Lee YS, Kim SB, Park SI, Ahn SD. Prognosis of esophageal cancer patients with pathologic complete response after preoperative concurrent chemoradiotherapy. Int J Radiat Oncol Biol Phys. 2011 Nov 1;81(3):691-7. doi: 10.1016/j.ijrobp.2010.06.041. Epub 2010 Oct 1. |
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|
| radiotherapy | Radiation | Concurrent radiotherapy: 50Gy in total,2 Gy/d,5d/w,Until disease progression or unacceptable toxicity |
|
|
| 16 weeks |
| quality of life, Qol | 16 weeks |
| pathologic complete response rate | 16 weeks |
| Xiaoshan Feng, Doctor | The First Affiliated Hospital of Henan University of Science and Technology | Study Director |
| Jiachun Sun, Doctor | The First Affiliated Hospital of Henan University of Science and Technology | Principal Investigator |
| Xinshuai Wang, Doctor | The First Affiliated Hospital of Henan University of Science and Technology | Principal Investigator |
| Guoqiang Kong, Master | The First Affiliated Hospital of Henan University of Science and Technology | Principal Investigator |
| Xiaozhi Yuan, Master | The First Affiliated Hospital of Henan University of Science and Technology | Principal Investigator |
| Ruinuo Jia, Master | The First Affiliated Hospital of Henan University of Science and Technology | Principal Investigator |
| Dan Zhuo, Master | The First Affiliated Hospital of Henan University of Science and Technology | Principal Investigator |
| Jing Ren, Master | The First Affiliated Hospital of Henan University of Science and Technology | Principal Investigator |
| Ruina Yang, Master | The First Affiliated Hospital of Henan University of Science and Technology | Principal Investigator |
| Yali Zhang, Master | The First Affiliated Hospital of Henan University of Science and Technology | Principal Investigator |
| Yongxuan Liu, Master | The First Affiliated Hospital of Henan University of Science and Technology | Principal Investigator |
| Wei Wang, Master | The First Affiliated Hospital of Henan University of Science and Technology | Principal Investigator |
| Dan Wang, Master | The First Affiliated Hospital of Henan University of Science and Technology | Principal Investigator |
| Weijiao Yin, Master | The First Affiliated Hospital of Henan University of Science and Technology | Principal Investigator |
| Shiyuan Song, Master | The First Affiliated Hospital of Henan University of Science and Technology | Principal Investigator |
| 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 |
|---|---|
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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