Chemoradiotherapy of Capecitabine With or Without Oxaliplatin Versus Cisplatin-5-FU for Esophageal Squamous Cancer

Stage III Esophageal Squamous Cell Carcinoma Clinical Trial

— CRTCOESC  

Official title:

Three-arm Phase III Trial Comparing Radiotherapy With Different Chemotherapy Regimens for Esophageal Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02025036
• Other study ID #: FirstHenanUST
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: October 2014
• Est. completion date: April 1, 2025

Study information

• Verified date: February 2023
• Source: The First Affiliated Hospital of Henan University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 249
• Est. completion date: April 1, 2025
• Est. primary completion date: September 13, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• age 18-75years 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.

Related Conditions & MeSH terms

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

Intervention

Drug:
• Capecitabine(Aibin)
capecitabine(Aibin):625mg/m2, bid d1-5; q1w, po,5 weeks in total
• Oxaliplatin(Aiheng)
Oxaliplatin(Aiheng):65mg/m2,d1,8, 22, 29,I.V.

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 (8)

Lead Sponsor	Collaborator
The First Affiliated Hospital of Henan University of Science and Technology	Anyang Cancer Hospital, Henan Oncology Hospital, Luoyang Central Hospital, Military 150 Hospital, Nanyang Central Hospital, Sanmenxia Central Hospital, The First Affiliated Hospital of Xinyang Medical College

Country where clinical trial is conducted

China, 

References & Publications (9)

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. — View Citation

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. Erratum In: Lancet Oncol. 2014 Dec;15(13):e587. Lancet Oncol. 2014 Dec;15(13):e587. — View Citation

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. — 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

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. — 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

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Grade 3/5 acute toxicities	Grade 3/5 acute toxicities occurred during or within 90 days after RT	90 days
Primary	OS-2 year	Overall Survival rate in 2 year from Randomization	2 years
Secondary	PFS-2 year	Progression Free Survival rate in 2 year from Randomization	2 years
Secondary	overall remission rate, ORR	overall remission rate after CRT	16 weeks
Secondary	quality of life, Qol	quality of life evaluation	16 weeks
Secondary	pathologic complete response rate	pathologic complete response rate confirmed by gastroscope biopsy	16 weeks