PFCRTESC: Different Cycles of Cisplatin-5-fluorouracil for the Chemoradiotherapy of Esophageal Squamous Cancer
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Two cycles PF-radiotherapy 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. |
Other: 2 cycles cisplatin-5-fluorouracil
2 cycles cisplatin-5-fluorouracil(PF 2 cycles): cisplatin: 75mg/m2 d1，29; 5-fluorouracil：750mg/m2 CIV24h d1-4，d29-32.
Other Names:
Radiation: Radiotherapy
concurrent radiotherapy： 50Gy in total，2 Gy/d，5d/w，Until disease progression or unacceptable toxicity
Other Names:
|
| Active Comparator: Four cycles PF-radiotherapy 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. |
Other: 4 cycles cisplatin-5-fluorouracil
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.
Other Names:
Radiation: Radiotherapy
concurrent radiotherapy： 50Gy in total，2 Gy/d，5d/w，Until disease progression or unacceptable toxicity
Other Names:
|
Outcome Measures
Primary Outcome Measures
- overall survival, OS [2 years]
Secondary Outcome Measures
- progression-free survival,PFS [2 years]
- overall remission rate, ORR [16 weeks]
- serious adverse event,SAE [16 weeks]
- quality of life, Qol [16 weeks]
- pathologic complete response rate [16 weeks]
- disease control rate,DCR [16 weeks]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
age 45-75years old
-
Histologically proven squamous cell carcinoma of the esophagus the tumor was in T2-4N0-2M0
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The patients have not received the surgery or chemo-radiotherapy.
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Hb≥80g/L, absolute neutrophil count ≥1.5×109/L, Plt≥90×109/L,
-
ALT、AST≤2.5N,Cr≤1.5N.
-
performance status score 0-2
Exclusion Criteria:
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pregnant, lactating women
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Oxaliplatin or fluorouracil Allergy or metabolic disorders
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Radiotherapy contraindications
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History of organ transplantation
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Brain metastasis
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The peripheral nervous system disorders
-
Severe infection
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Oral capecitabine who have difficulty with,such as dysphagia,The activities of digestive ulcer, Gastrointestinal bleeding
-
Severe chronic diseases, such as, hepatopathy, nephropathy, respiratory disease,high blood pressure, diabetes.
-
Other malignant tumor in recent 5 years.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The First Affiliated Hospital of Henan University of Science and Technology | Luoyang | Henan | China | 471003 |
Sponsors and Collaborators
- The First Affiliated Hospital of Henan University of Science and Technology
Investigators
- Study Chair: Shegan Gao, Doctor, The First Affiliated Hospital of Henan University of Science and Technology
- Study Director: Tanyou Shan, Master, The First Affiliated Hospital of Henan University of Science and Technology
- Study Director: Xiaoshan Feng, Doctor, The First Affiliated Hospital of Henan University of Science and Technology
- Principal Investigator: 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
Study Documents (Full-Text)
None provided.More Information
Publications
- Bedenne L, Michel P, Bouché 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.
- 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.
- 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. Erratum in: Jpn J Clin Oncol. 2005 Feb;35(2):108.
- 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.
- 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.
- 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.
- 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.
- 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.
- PF and esophageal cancer