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| Name | Class |
|---|---|
| Luoyang Central Hospital | OTHER |
| Military 150 Hospital | UNKNOWN |
| Anyang Cancer Hospital | UNKNOWN |
| Nanyang Central Hospital |
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A three-arm Phase III trial was started in Oct. 2014. Definitive chemoradiotherapy 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, the chemotherapy regimen of capecitabine with or without oxaliplatin are widely used in clinical.
The purpose of this study is to confirm the difference of Capecitabine plus with or without oxaliplatin over cisplatin plus 5-fluorouracil with definitive chemoradiotherapy for esophagus squamous cell carcinoma. A total of 249 patients will be accrued from China within 2 years. The primary endpoints are grade 3-5 AEs and overall survival and the secondary endpoints include progression-free survival, response rate, pathologic complete response rate.
We plan to recruit the patients who were pathologically confirmed with esophageal squamous cell carcinoma from the Oct 2014. The patients will be divided into three groups.Experimental group 1 : single drug Capecitabine and concurrent radiotherapy.Experimental group 2: Capecitabine plus oxaliplatin and concurrent radiotherapy. Control group:cisplatin plus 5-fluorouracil and concurrent radiotherapy. To evaluate the adverse events and the overall survival of the three group. Also observe the patient's progression-free survival, response rate, pathologic complete response rate.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Capecitabine-oxaliplatin-radiotherapy | Experimental | oxaliplatin：65mg/m2，d1，8，22, 29,I.V.or d1, 8, 22, 29, 43, 50, 64, 71,I.V.plus,capecitabine: 625mg/m2, bid d1-5; q1w, po,6 weeks or 12 weeks in total. radiotherapy： 50-50.4Gy ，1.8-2 Gy/d，5d/w. |
|
| cisplatin with 5-FU and radiotherapy | Active Comparator | cisplatin: 75mg/m2 d1，29 or d1, 29, 57, 85, 5-Fu：750mg/m2 CIV24h d1-4，d29-32 or d1-4，d29-32, d57-60, d85-88. radiotherapy： 50-50.4Gy ，1.8-2 Gy/d，5d/w. |
|
| Capecitabine and radiotherapy | Experimental | capecitabine: 625mg/m2, bid d1-5; q1w, po,6 weeks or 12 weeks in total, radiotherapy： 50-50.4Gy ，1.8-2 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 weeks in total |
|
| Measure | Description | Time Frame |
|---|---|---|
| Grade 3/5 acute toxicities | Grade 3/5 acute toxicities occurred during or within 90 days after RT | 90 days |
| OS-2 year | Overall Survival rate in 2 year from Randomization | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| PFS-2 year | Progression Free Survival rate in 2 year from Randomization | 2 years |
| overall remission rate, ORR | overall remission rate after CRT |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shegan Gao, M.D Ph.D | The First Affiliated Hospital of Henan University of Science and Technology | Study Chair |
| Tanyou Shan, M.D M.S | The First Affiliated Hospital of Henan University of Science and Technology | Study Director |
| Xiaoshan Feng, M.D Ph.D | The First Affiliated Hospital of Henan University of Science and Technology | Study Director |
| Jiachun Sun, M.D Ph.D | The First Affiliated Hospital of Henan University of Science and Technology | Principal Investigator |
| Xinshuai Wang, M.D Ph.D | The First Affiliated Hospital of Henan University of Science and Technology | Principal Investigator |
| Guoqiang Kong, M.D M.S | The First Affiliated Hospital of Henan University of Science and Technology | Principal Investigator |
| Xiaozhi Yuan, M.D M.S | The First Affiliated Hospital of Henan University of Science and Technology | Principal Investigator |
| Ruinuo Jia, M.D Ph.D | The First Affiliated Hospital of Henan University of Science and Technology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Henan University of Science and Technology | 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. | |
| 23335087 | Background |
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| OTHER |
| Henan Oncology Hospital | UNKNOWN |
| The First Affiliated Hospital of Xinyang Medical College | UNKNOWN |
| Sanmenxia Central Hospital | OTHER |
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|
| Oxaliplatin(Aiheng) | Drug | Oxaliplatin(Aiheng)：65mg/m2，d1，8, 22, 29,I.V. |
|
|
| Radiotherapy | Radiation | concurrent radiotherapy： 50Gy in total，2 Gy/d，5d/w，Until disease progression or unacceptable toxicity |
|
|
| 16 weeks |
| quality of life, Qol | quality of life evaluation | 16 weeks |
| pathologic complete response rate | pathologic complete response rate confirmed by gastroscope biopsy | 16 weeks |
| Dan Zhou, M.D M.S | The First Affiliated Hospital of Henan University of Science and Technology | Principal Investigator |
| Jing Ren, M.D M.S | The First Affiliated Hospital of Henan University of Science and Technology | Principal Investigator |
| Ruina Yang, M.D M.S | The First Affiliated Hospital of Henan University of Science and Technology | Principal Investigator |
| Dan Wang, M.D M.S | The First Affiliated Hospital of Henan University of Science and Technology | Principal Investigator |
| Wei Wang, M.D M.S | The First Affiliated Hospital of Henan University of Science and Technology | Principal Investigator |
| Yali Zhang, M.D M.S | The First Affiliated Hospital of Henan University of Science and Technology | Principal Investigator |
| Yongxuan Liu, M.D M.S | The First Affiliated Hospital of Henan University of Science and Technology | Principal Investigator |
| Weijiao Yin, M.D M.S | The First Affiliated Hospital of Henan University of Science and Technology | Principal Investigator |
| Shiyuan Song, M.D M.S | The First Affiliated Hospital of Henan University of Science and Technology | Principal Investigator |
| Guobao Zheng, M.D Ph.D | No. 150 Central Hospital of the Chinese People Liberation Army | Principal Investigator |
| Daoke Yang, M.D M.S | The First Affiliated Hospital of Zhengzhou University | Principal Investigator |
| Jianhua Wang, M.D Ph.D | Henan Tumor Hospital | Principal Investigator |
| Fuyou Zhou, M.D Ph.D | Anyang Tumour Hospital of Henan province | Principal Investigator |
| Nengchao Wang, M.D M.S | Anyang Tumour Hospital of Henan province | Principal Investigator |
| Anping Zheng, M.D M.S | Anyang Tumour Hospital of Henan province | Principal Investigator |
| Zhanhui Miao, M.D M.S | Affiliated Hospital of Xinxiang Medical University, Henan province | Principal Investigator |
| Ruiwen Zhang, M.D M.S | Xinxiang Central Hospital of Henan province | Principal Investigator |
| Siegel R, Naishadham D, Jemal A. Cancer statistics, 2013. CA Cancer J Clin. 2013 Jan;63(1):11-30. doi: 10.3322/caac.21166. Epub 2013 Jan 17. |
| 25651787 | Background | Torre LA, Bray F, Siegel RL, Ferlay J, Lortet-Tieulent J, Jemal A. Global cancer statistics, 2012. CA Cancer J Clin. 2015 Mar;65(2):87-108. doi: 10.3322/caac.21262. Epub 2015 Feb 4. |
| 24199704 | Background | Blum MA, Taketa T, Sudo K, Wadhwa R, Skinner HD, Ajani JA. Chemoradiation for esophageal cancer. Thorac Surg Clin. 2013 Nov;23(4):551-8. doi: 10.1016/j.thorsurg.2013.07.006. |
| 24556041 | Background | Conroy T, Galais MP, Raoul JL, Bouche O, Gourgou-Bourgade S, Douillard JY, Etienne PL, Boige V, Martel-Lafay I, Michel P, Llacer-Moscardo C, Francois E, Crehange G, Abdelghani MB, Juzyna B, Bedenne L, Adenis A; Federation Francophone de Cancerologie Digestive and UNICANCER-GI Group. Definitive chemoradiotherapy with FOLFOX versus fluorouracil and cisplatin in patients with oesophageal cancer (PRODIGE5/ACCORD17): final results of a randomised, phase 2/3 trial. Lancet Oncol. 2014 Mar;15(3):305-14. doi: 10.1016/S1470-2045(14)70028-2. Epub 2014 Feb 18. |
| 20932658 | Background | Kato K, Muro K, Minashi K, Ohtsu A, Ishikura S, Boku N, Takiuchi H, Komatsu Y, Miyata Y, Fukuda H; Gastrointestinal Oncology Study Group of the Japan Clinical Oncology Group (JCOG). Phase II study of chemoradiotherapy with 5-fluorouracil and cisplatin for Stage II-III esophageal squamous cell carcinoma: JCOG trial (JCOG 9906). Int J Radiat Oncol Biol Phys. 2011 Nov 1;81(3):684-90. doi: 10.1016/j.ijrobp.2010.06.033. Epub 2010 Oct 6. |
| 23585687 | Background | Kato K, Nakajima TE, Ito Y, Katada C, Ishiyama H, Tokunaga SY, Tanaka M, Hironaka S, Hashimoto T, Ura T, Kodaira T, Yoshimura K. Phase II study of concurrent chemoradiotherapy at the dose of 50.4 Gy with elective nodal irradiation for Stage II-III esophageal carcinoma. Jpn J Clin Oncol. 2013 Jun;43(6):608-15. doi: 10.1093/jjco/hyt048. Epub 2013 Apr 12. |
| 19270824 | Background | Lee SJ, Ahn BM, Kim JG, Sohn SK, Chae YS, Moon JH, Lee EB, Kim JC, Park IK, Jeon SW. Definitive chemoradiotherapy with capecitabine and cisplatin in patients with esophageal cancer: a pilot study. J Korean Med Sci. 2009 Feb;24(1):120-5. doi: 10.3346/jkms.2009.24.1.120. Epub 2009 Feb 28. |
| 24578238 | Background | Xing L, Liang Y, Zhang J, Wu P, Xu D, Liu F, Yu X, Jiang Z, Song X, Zang Q, Wang W. Definitive chemoradiotherapy with capecitabine and cisplatin for elder patients with locally advanced squamous cell esophageal cancer. J Cancer Res Clin Oncol. 2014 May;140(5):867-72. doi: 10.1007/s00432-014-1615-5. Epub 2014 Mar 1. |
| 38710003 | Derived | Jia R, Shan T, Zheng A, Zhang Y, Lu P, Zhang G, Wang F, Xu Z, Zheng G, Tang D, Zhang W, Li W, Li R, Guo Y, Liu L, Luo X, Zheng Y, Chang Z, Wang Q, Wang X, Yuan X, Kong G, Li S, Yang R, Zhou D, Ren J, Yin W, Li J, Zhang J, Wang Z, Sheng M, Xu B, Li L, Liu X, Lu Z, Wan L, Zhou F, Gao S. Capecitabine or Capecitabine Plus Oxaliplatin Versus Fluorouracil Plus Cisplatin in Definitive Concurrent Chemoradiotherapy for Locally Advanced Esophageal Squamous Cell Carcinoma (CRTCOESC): A Multicenter, Randomized, Open-Label, Phase 3 Trial. J Clin Oncol. 2024 Jul 10;42(20):2436-2445. doi: 10.1200/JCO.23.02009. Epub 2024 May 6. |
| 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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