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A two-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.
The purpose of this study is to confirm the difference of 2 and 4 cycles of cisplatin plus 5-fluorouracil in the definitive chemoradiotherapy for esophagus squamous cell carcinoma. A total of 210 patients will be accrued from China within 2 years. The primary endpoint is overall survival and the secondary endpoints include progression-free survival, response rate, pathologic complete response rate and adverse events.
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 two groups.Experimental group: Two cycles of cisplatin plus 5-fluorouracil concurrent radiotherapy.Control group:Four cycles of cisplatin plus 5-fluorouracil and concurrent radiotherapy.To evaluate the overall survival of the 2 group. Also observe the patient's progression-free survival, response rate, pathologic complete response rate and adverse events.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Two cycles PF-radiotherapy | Experimental | 2 cycles cisplatin-5-fluorouracil: cisplatin: 75mg/m2 d1，29；5-fluorouracil：750mg/m2 CIV24h d1-4，d29-32. radiotherapy： 50Gy，2 Gy/d，5d/w. |
|
| Four cycles PF-radiotherapy | Active Comparator | 4 cycles cisplatin-5-fluorouracil: cisplatin: 75mg/m2 d1，29, 57, 85；5-fluorouracil：750mg/m2 CIV24h d1-4，d29-32, d57-60, d85-88. radiotherapy： 50Gy，2 Gy/d，5d/w. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 2 cycles cisplatin-5-fluorouracil | Other | 2 cycles cisplatin-5-fluorouracil(PF 2 cycles): cisplatin: 75mg/m2 d1，29; 5-fluorouracil：750mg/m2 CIV24h d1-4，d29-32. |
|
| Measure | Description | Time Frame |
|---|---|---|
| overall survival, OS | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| progression-free survival,PFS | 2 years | |
| overall remission rate, ORR | 16 weeks | |
| serious adverse event,SAE |
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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. | |
| 11870157 | Background |
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|
| 4 cycles cisplatin-5-fluorouracil | Other | 4 cycles cisplatin-5-fluoroura(PF 4 cycles): cilcisplatin: 75mg/m2 d1，29, 57, 85; 5-fluorouracil：750mg/m2 CIV24h d1-4，d29-32, d57-60, d85-88. |
|
|
| 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 |
| disease control rate,DCR | 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 Zhou, 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 |
| Wei Wang, 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 |
| Dan Wang, 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 |
| Weijiao Yin, 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 |
| Minsky BD, Pajak TF, Ginsberg RJ, Pisansky TM, Martenson J, Komaki R, Okawara G, Rosenthal SA, Kelsen DP. INT 0123 (Radiation Therapy Oncology Group 94-05) phase III trial of combined-modality therapy for esophageal cancer: high-dose versus standard-dose radiation therapy. J Clin Oncol. 2002 Mar 1;20(5):1167-74. doi: 10.1200/JCO.2002.20.5.1167. |
| 10561371 | Background | Ohtsu A, Boku N, Muro K, Chin K, Muto M, Yoshida S, Satake M, Ishikura S, Ogino T, Miyata Y, Seki S, Kaneko K, Nakamura A. Definitive chemoradiotherapy for T4 and/or M1 lymph node squamous cell carcinoma of the esophagus. J Clin Oncol. 1999 Sep;17(9):2915-21. doi: 10.1200/JCO.1999.17.9.2915. |
| 15591460 | Background | Ishida K, Ando N, Yamamoto S, Ide H, Shinoda M. Phase II study of cisplatin and 5-fluorouracil with concurrent radiotherapy in advanced squamous cell carcinoma of the esophagus: a Japan Esophageal Oncology Group (JEOG)/Japan Clinical Oncology Group trial (JCOG9516). Jpn J Clin Oncol. 2004 Oct;34(10):615-9. doi: 10.1093/jjco/hyh107. |
| 12957254 | Background | Hironaka S, Ohtsu A, Boku N, Muto M, Nagashima F, Saito H, Yoshida S, Nishimura M, Haruno M, Ishikura S, Ogino T, Yamamoto S, Ochiai A. Nonrandomized comparison between definitive chemoradiotherapy and radical surgery in patients with T(2-3)N(any) M(0) squamous cell carcinoma of the esophagus. Int J Radiat Oncol Biol Phys. 2003 Oct 1;57(2):425-33. doi: 10.1016/s0360-3016(03)00585-6. |
| 17401004 | Background | Bedenne L, Michel P, Bouche O, Milan C, Mariette C, Conroy T, Pezet D, Roullet B, Seitz JF, Herr JP, Paillot B, Arveux P, Bonnetain F, Binquet C. Chemoradiation followed by surgery compared with chemoradiation alone in squamous cancer of the esophagus: FFCD 9102. J Clin Oncol. 2007 Apr 1;25(10):1160-8. doi: 10.1200/JCO.2005.04.7118. |
| 24096766 | Background | Shapiro J, ten Kate FJ, van Hagen P, Biermann K, Wijnhoven BP, van Lanschot JJ. Residual esophageal cancer after neoadjuvant chemoradiotherapy frequently involves the mucosa and submucosa. Ann Surg. 2013 Nov;258(5):678-88; discussion 688-9. doi: 10.1097/SLA.0b013e3182a6191d. |
| 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. |
| 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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