NCT02972372

Brief Summary

The aim of this study is to compare outcomes in Chinese patients with locally advanced resectable esophageal squamous cell cancer who have received either surgery or definitive chemoradiation (CRT) by the randomized, open-label, multicenter trial.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
196

participants targeted

Target at P75+ for not_applicable

Timeline
19mo left

Started Nov 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress86%
Nov 2016Dec 2027

Study Start

First participant enrolled

November 1, 2016

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

November 6, 2016

Completed
17 days until next milestone

First Posted

Study publicly available on registry

November 23, 2016

Completed
9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Expected
Last Updated

February 10, 2025

Status Verified

February 1, 2025

Enrollment Period

9.1 years

First QC Date

November 6, 2016

Last Update Submit

February 6, 2025

Conditions

Esophagus Cancer

Keywords

esophageal cancerchemoradiationesophagectomy

Outcome Measures

Primary Outcomes (1)

  • 2-year disease-free survival rate

    The percent of 2 year disease-free survival after random allocation, percent

    2 year

Secondary Outcomes (3)

  • Treatment-related adverse events

    2 year

  • QoF (quality of life)

    2 year

  • 2 year overall survival

    2 year

Study Arms (2)

CRT group

ACTIVE COMPARATOR

3-weekly cycles of cisplatin and 5-fluorouracil chemotherapy and radical radiotherapy delivered in IMRT mode (total of 50Gy given in 25 fractions) will be given over a period 5-6 weeks.

Procedure: CRT

Surgery group

ACTIVE COMPARATOR

The patients randomized to receive either standard esophagectomy will have the operation performed in an open manner with two-field lymphadenectomy

Procedure: surgery

Interventions

CRTPROCEDURE

Drug: Capecitabine(Aibin) capecitabine(Aibin)：625mg/m2, bid d1-5; q1w, po,5 weeks in total Other Names: Aibin Drug: Oxaliplatin(Aiheng) Oxaliplatin(Aiheng)：65mg/m2，d1，8, 22, 29,I.V. Other Names: Aiheng 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. Radiation: Radiotherapy concurrent radiotherapy：IMRT radiotherapy 50Gy in total，2 Gy/d，5d/w，Until disease progression or unacceptable toxicity

Also known as: concurrent chemoradiotherapy
CRT group
surgeryPROCEDURE

The patients randomized to receive either standard esophagectomy will have the operation performed in an open manner with two-field lymphadenectomy

Also known as: esophagectomy
Surgery group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Chinese
  • esophageal squamous cell cancer
  • mid or lower esophageal cancer
  • tumor is resectable disease
  • clinical stage: cT1bN+Mo, or cT2-4aN0-2M0

You may not qualify if:

  • who had distant metastasis to solid visceral organs or local invasion into trachea, descending aorta, or recurrent laryngeal nerve.
  • who had a serious premorbid condition or a poor physical status that compromised a thoracotomy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Anyang Tumor Hospital

Anyang, Henan, China

RECRUITING

The First Affiliated Hospital, and College of Clinical Medicine of Henan University of Science and Technology

Luoyang, Henan, 471003, China

RECRUITING

Related Publications (12)

  • Teoh AY, Chiu PW, Yeung WK, Liu SY, Wong SK, Ng EK. Long-term survival outcomes after definitive chemoradiation versus surgery in patients with resectable squamous carcinoma of the esophagus: results from a randomized controlled trial. Ann Oncol. 2013 Jan;24(1):165-71. doi: 10.1093/annonc/mds206. Epub 2012 Aug 10.

    PMID: 22887465BACKGROUND

  • Teoh AY, Yan Chiu PW, Wong TC, Liu SY, Hung Wong SK, Ng EK. Functional performance and quality of life in patients with squamous esophageal carcinoma receiving surgery or chemoradiation: results from a randomized trial. Ann Surg. 2011 Jan;253(1):1-5. doi: 10.1097/SLA.0b013e3181fcd991.

    PMID: 21233603BACKGROUND

  • 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: 20888705BACKGROUND

  • 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: 23335087BACKGROUND

  • 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: 25651787BACKGROUND

  • 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: 24199704BACKGROUND

  • 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: 24556041BACKGROUND

  • 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: 20932658BACKGROUND

  • 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: 23585687BACKGROUND

  • 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: 19270824BACKGROUND

  • 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: 24578238BACKGROUND

  • Jia R, Yin W, Li S, Li R, Yang J, Shan T, Zhou D, Wang W, Wan L, Zhou F, Gao S. Chemoradiation versus oesophagectomy for locally advanced oesophageal cancer in Chinese patients: study protocol for a randomised controlled trial. Trials. 2019 Apr 11;20(1):206. doi: 10.1186/s13063-019-3316-5.

    PMID: 30971301DERIVED

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

ChemoradiotherapySurgical Procedures, OperativeEsophagectomy

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Combined Modality TherapyTherapeuticsDrug TherapyRadiotherapyDigestive System Surgical Procedures

Study Officials

  • Shegan Gao, MD, PhD

    The First Affiliated Hospital, and College of Clinical Medicine of Henan University of Science and Technology

    STUDY CHAIR

  • Fuyou Zhou, MD, PhD

    Anyang Tumor Hospital

    STUDY CHAIR

  • Ruinuo Jia, MD

    The First Affiliated Hospital, and College of Clinical Medicine of Henan University of Science and Technology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shegan Gao, MD, PhD

CONTACT

+86 18638859977gsg112258@163.com

Ruinuo Jia, MD

CONTACT

+86 18537950766jiaruinuo@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 6, 2016

First Posted

November 23, 2016

Study Start

November 1, 2016

Primary Completion

December 1, 2025

Study Completion (Estimated)

December 1, 2027

Last Updated

February 10, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations

CN(2)