Different Cycles of Cisplatin-5-fluorouracil for the Chemoradiotherapy of Esophageal Squamous Cancer

Stage III Esophageal Squamous Cell Carcinoma Clinical Trial

— PFCRTESC  

Official title:

Two-arm Phase III Trial Comparing Radiotherapy With Differentcycles of Cisplatin-5-fluorouracil for Esophageal Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02607540
• Other study ID #: PF and esophageal cancer
• Status: Recruiting
• Phase: Phase 3
• First received: November 16, 2015
• Last updated: January 10, 2016
• Start date: October 2014
• Est. completion date: December 2020

Study information

• Verified date: January 2016
• Source: The First Affiliated Hospital of Henan University of Science and Technology
• Contact: Shegan Gao, Doctor
• Phone: 18638859977
• Email: gsg112258[@]163.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 210
• Est. completion date: December 2020
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years to 75 Years

Eligibility

Inclusion Criteria:

• age 45-75years old

• Histologically proven squamous cell carcinoma of the esophagus the tumor was in T2-4N0-2M0

• The patients have not received the surgery or chemo-radiotherapy.

• Hb=80g/L, absolute neutrophil count =1.5×109/L, Plt=90×109/L,

• ALT?AST=2.5*N,Cr=1.5*N.

• performance status score 0-2

Exclusion Criteria:

• pregnant, lactating women

• Oxaliplatin or fluorouracil Allergy or metabolic disorders

• Radiotherapy contraindications

• History of organ transplantation

• Brain metastasis

• The peripheral nervous system disorders

• Severe infection

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Esophageal Neoplasms
• Stage II Esophageal Squamous Cell Carcinoma
• Stage III Esophageal Squamous Cell Carcinoma

Intervention

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.
• 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.

Radiation:
• Radiotherapy
concurrent radiotherapy: 50Gy in total,2 Gy/d,5d/w,Until disease progression or unacceptable toxicity

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Henan University of Science and Technology	Luoyang	Henan

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital of Henan University of Science and Technology

Country where clinical trial is conducted

China, 

References & Publications (8)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall survival, OS		2 years	Yes
Secondary	progression-free survival,PFS		2 years	Yes
Secondary	overall remission rate, ORR		16 weeks	No
Secondary	serious adverse event,SAE		16 weeks	Yes
Secondary	quality of life, Qol		16 weeks	No
Secondary	pathologic complete response rate		16 weeks	No
Secondary	disease control rate,DCR		16 weeks	No