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

NCT02025036 | Unknown Phase 3 DMC

• 1 other identifier: FirstHenanUST
• Study Type: interventional
• Target: 249
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Stage III Esophageal Squamous Cell Carcinoma; Stage II Esophageal Squamous Cell Carcinoma

Keywords

Chemoradiotherapy， Esophageal Squamous Cancer

Outcome Measures

Primary Outcomes (2)

• Grade 3/5 acute toxicities

  Grade 3/5 acute toxicities occurred during or within 90 days after RT

  90 days

• OS-2 year

  Overall Survival rate in 2 year from Randomization

  2 years

Secondary Outcomes (4)

• PFS-2 year

  2 years

• overall remission rate, ORR

  16 weeks

• quality of life, Qol

  16 weeks

• pathologic complete response rate

  16 weeks

Study Arms (3)

Capecitabine-oxaliplatin-radiotherapy

EXPERIMENTAL

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); Drug: Oxaliplatin(Aiheng); Radiation: Radiotherapy

cisplatin with 5-FU and radiotherapy

ACTIVE COMPARATOR

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

Capecitabine and radiotherapy

EXPERIMENTAL

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); Radiation: Radiotherapy

Interventions

Capecitabine(Aibin) DRUG

capecitabine(Aibin)：625mg/m2, bid d1-5; q1w, po,5 weeks in total

Also known as: Aibin

Capecitabine and radiotherapy; Capecitabine-oxaliplatin-radiotherapy

Oxaliplatin(Aiheng) DRUG

Oxaliplatin(Aiheng)：65mg/m2，d1，8, 22, 29,I.V.

Also known as: Aiheng

Capecitabine-oxaliplatin-radiotherapy

Radiotherapy RADIATION

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

Also known as: Radiation Therapy

Capecitabine and radiotherapy; Capecitabine-oxaliplatin-radiotherapy; cisplatin with 5-FU and radiotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First Affiliated Hospital of Henan University of Science and Technology: lead
• Luoyang Central Hospital: collaborator
• Military 150 Hospital: collaborator
• Anyang Cancer Hospital: collaborator
• Nanyang Central Hospital: collaborator
• Henan Oncology Hospital: collaborator
• The First Affiliated Hospital of Xinyang Medical College: collaborator
• Sanmenxia Central Hospital: collaborator

Study Sites (1)

The First Affiliated Hospital of Henan University of Science and Technology

Luoyang, Henan, 471003, China

Location

Related Publications (10)

• 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.

  PMID: 20888705 BACKGROUND

• 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.

  PMID: 23335087 BACKGROUND

• 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.

  PMID: 25651787 BACKGROUND

• 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.

  PMID: 24199704 BACKGROUND

• 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.

  PMID: 24556041 BACKGROUND

• 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.

  PMID: 20932658 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.

  PMID: 23585687 BACKGROUND

• 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.

  PMID: 19270824 BACKGROUND

• 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.

  PMID: 24578238 BACKGROUND

• Jia R, Shan T, Zheng A, Zhang Y, Lu P, Zhang G, Wang F, Xu Z, Zheng G, Tang D, Zhang W, Li W, Li R, Guo Y, Liu L, Luo X, Zheng Y, Chang Z, Wang Q, Wang X, Yuan X, Kong G, Li S, Yang R, Zhou D, Ren J, Yin W, Li J, Zhang J, Wang Z, Sheng M, Xu B, Li L, Liu X, Lu Z, Wan L, Zhou F, Gao S. Capecitabine or Capecitabine Plus Oxaliplatin Versus Fluorouracil Plus Cisplatin in Definitive Concurrent Chemoradiotherapy for Locally Advanced Esophageal Squamous Cell Carcinoma (CRTCOESC): A Multicenter, Randomized, Open-Label, Phase 3 Trial. J Clin Oncol. 2024 Jul 10;42(20):2436-2445. doi: 10.1200/JCO.23.02009. Epub 2024 May 6.

  PMID: 38710003 DERIVED

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Carcinoma, 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

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Shegan Gao, M.D Ph.D

  The First Affiliated Hospital of Henan University of Science and Technology

  STUDY CHAIR

• 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

  STUDY DIRECTOR

• 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 Ph.D

  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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2013
• First Posted: December 31, 2013
• Study Start: October 1, 2014
• Primary Completion: September 13, 2022
• Study Completion: April 1, 2025
• Last Updated: February 8, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)