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

• ClinicalTrials.gov Identifier: NCT02025036
• Recruitment Status: Unknown
• First Posted: December 31, 2013
• Last Update Posted: May 1, 2020
• Sponsor: The First Affiliated Hospital of Henan University of Science and Technology
• Collaborators: Luoyang Central Hospital; Military 150 Hospital; Anyang Cancer Hospital; Nanyang Central Hospital; Henan Oncology Hospital; The First Affiliated Hospital of Xinyang Medical College; Sanmenxia Central Hospital
• Information provided by (Responsible Party): The First Affiliated Hospital of Henan University of Science and Technology

Study Description

Brief 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 630 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
Stage III Esophageal Squamous Cell Carcinoma; Stage II Esophageal Squamous Cell Carcinoma	Drug: Capecitabine(Aibin); Drug: Oxaliplatin(Aiheng); Radiation: Radiotherapy	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 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 overall survival of the three group. Also observe the patient's progression-free survival, response rate, pathologic complete response rate and adverse events.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 249 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Three-arm Phase III Trial Comparing Radiotherapy With Different Chemotherapy Regimens for Esophageal Cancer
• Actual Study Start Date: October 2014
• Estimated Primary Completion Date: April 25, 2022
• Estimated Study Completion Date: April 25, 2022

Arms and Interventions

Arm	Intervention/treatment
Experimental: Capecitabine-oxaliplatin-radiotherapy; 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.	Drug: Capecitabine(Aibin); capecitabine(Aibin)：625mg/m2, bid d1-5; q1w, po,5 weeks in total; Other Name: Aibin; Drug: Oxaliplatin(Aiheng); Oxaliplatin(Aiheng)：65mg/m2，d1，8, 22, 29,I.V.; Other Name: Aiheng; Radiation: Radiotherapy; concurrent radiotherapy： 50Gy in total，2 Gy/d，5d/w，Until disease progression or unacceptable toxicity; Other Name: Radiation Therapy
Active Comparator: cisplatin with 5-FU and radiotherapy; 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.	Radiation: Radiotherapy; concurrent radiotherapy： 50Gy in total，2 Gy/d，5d/w，Until disease progression or unacceptable toxicity; Other Name: Radiation Therapy
Experimental: Capecitabine and radiotherapy; 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.	Drug: Capecitabine(Aibin); capecitabine(Aibin)：625mg/m2, bid d1-5; q1w, po,5 weeks in total; Other Name: Aibin; Radiation: Radiotherapy; concurrent radiotherapy： 50Gy in total，2 Gy/d，5d/w，Until disease progression or unacceptable toxicity; Other Name: Radiation Therapy

Outcome Measures

Primary Outcome Measures :

1. Grade 3/4 acute toxicities [ Time Frame: 90 days ]
   Grade 3/4 acute toxicities occurred during or within 90 days after RT
2. PFS-2 year [ Time Frame: 2 years ]
   Progression Free Survival rate in 2 year from Randomization

Secondary Outcome Measures :

1. OS-2 year [ Time Frame: 2 years ]
   Overall Survival rate in 2 year from Randomization
2. overall remission rate, ORR [ Time Frame: 16 weeks ]
   overall remission rate after CRT
3. quality of life, Qol [ Time Frame: 16 weeks ]
   quality of life evaluation
4. pathologic complete response rate [ Time Frame: 16 weeks ]
   pathologic complete response rate confirmed by gastroscope biopsy

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

China, Henan

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

Luoyang Central Hospital

Military 150 Hospital

Anyang Cancer Hospital

Nanyang Central Hospital

Henan Oncology Hospital

The First Affiliated Hospital of Xinyang Medical College

Sanmenxia Central Hospital

Investigators

• Study Chair: Shegan Gao, M.D Ph.D; The First Affiliated Hospital of Henan University of Science and Technology
• Study Director: 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
• Principal Investigator: 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 M.S; The First Affiliated Hospital of Henan University of Science and Technology
• Principal Investigator: 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

More Information

Publications:

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.

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.

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.

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. Review.

Conroy T, Galais MP, Raoul JL, Bouché O, Gourgou-Bourgade S, Douillard JY, Etienne PL, Boige V, Martel-Lafay I, Michel P, Llacer-Moscardo C, François E, Créhange G, Abdelghani MB, Juzyna B, Bedenne L, Adenis A; Fédération Francophone de Cancérologie 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. Erratum in: Lancet Oncol. 2014 Dec;15(13):e587.

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.

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.

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.

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.

• Responsible Party: The First Affiliated Hospital of Henan University of Science and Technology
• ClinicalTrials.gov Identifier: NCT02025036
• Other Study ID Numbers: FirstHenanUST
• First Posted: December 31, 2013
• Last Update Posted: May 1, 2020
• Last Verified: April 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Keywords provided by The First Affiliated Hospital of Henan University of Science and Technology:

Chemoradiotherapy， Esophageal Squamous Cancer

Additional relevant MeSH terms:

Carcinoma; Carcinoma, Squamous Cell; Esophageal Squamous Cell Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Esophageal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Capecitabine; Oxaliplatin; Antimetabolites, Antineoplastic; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents