Surgery or Chemoradiotherapy for Cervical Esophageal Cancer

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ClinicalTrials.gov Identifier: NCT05327517

Recruitment Status : Recruiting

First Posted : April 14, 2022

Last Update Posted : April 14, 2022

See Contacts and Locations

View this study on the modernized ClinicalTrials.gov

Sponsor:

Information provided by (Responsible Party):

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Tracking Information

First Submitted Date ^ICMJE

April 7, 2022

First Posted Date ^ICMJE

April 14, 2022

Last Update Posted Date

April 14, 2022

Estimated Study Start Date ^ICMJE

April 10, 2022

Estimated Primary Completion Date

December 31, 2028 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Overall Survival [ Time Frame: 5 years after surgery or definitive Chemoradiotherapy is completed ]

5 year overall survival

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Laryngo-esophageal dysfunction free survival [ Time Frame: 5 years after surgery or definitive Chemoradiotherapy is completed ]

5 year laryngo-esophageal dysfunction free survival

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Pre-specified Outcome Measures

Not Provided

Original Other Pre-specified Outcome Measures

Not Provided

Descriptive Information

Brief Title ^ICMJE

Surgery or Chemoradiotherapy for Cervical Esophageal Cancer

Official Title ^ICMJE

Surgery Versus Definitive Chemoradiotherapy for Resectable Cervical Esophageal Squamous Cell Carcinoma: A Prospective Multicenter Open-Label Clinical Trial

Brief Summary

To compare surgery with definitive chemoradiotherapy for patients with resectable cervical esophageal squamous cell carcinoma.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase ^ICMJE

Not Applicable

Study Design ^ICMJE

Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Condition ^ICMJE

Cervical Esophageal Cancer

Intervention ^ICMJE

Procedure: Esophagectomy

Patients receive esophagectomy or definitive chemoradiotherapy according to patient preference

Other Name: Definitive chemoradiotherapy

Study Arms ^ICMJE

Experimental: Surgery
Patients receive esophagectomy or neoadjuvant therapy plus esophagectomy

Intervention: Procedure: Esophagectomy
Active Comparator: Definitive chemoradiotherapy
Patients receive definitive chemoradiotherapy

Intervention: Procedure: Esophagectomy

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

192

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date ^ICMJE

December 31, 2028

Estimated Primary Completion Date

December 31, 2028 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Patients with resectable cervical esophageal squamous cell carcinoma (cT1b-T4aN0-3M0);
Cervical esophageal cancers spreads upwards to involve the hypopharynx and downwards to involve the thoracic esophagus can also be included;
Aged 18-75 years;
Without any contraindication of operation;
Hemoglobin >=90 g/L; Leukocytes >=4.0x10^9/L; Absolute neutrophil count >=1.5x10^9/L; Platelet >=100x10^9/L;Total bilirubin <=1.5 ULN; ALT <=2.5 ULN; AST <=2.5 ULN; Serum creatinine <=1.5 ULN or creatinine clearance rate >=50 mL/min (Cocheroft-Gault);INR <=1.5 ULN; APTT <=1.5 ULN;
Without other malignancies;
Expected R0 resection;
ECOG PS 0-1;
Volunteered to participate in the study, signed the informed consent form.

Exclusion Criteria:

Without other malignancies;
With mental diseases;
With hemorrhagic disease;
Inoperable patients;
Pregnant or lactating women;
Has a history of allergy to paclitaxel or cisplatin

Sex/Gender ^ICMJE

Sexes Eligible for Study:

All

Ages ^ICMJE

18 Years to 75 Years (Adult, Older Adult)

Accepts Healthy Volunteers ^ICMJE

Contacts ^ICMJE

Contact: Zhen Wang, MD

+8613600892432

wangzhen@cicams.ac.cn

Listed Location Countries ^ICMJE

China

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT05327517

Other Study ID Numbers ^ICMJE

NCC3281

Has Data Monitoring Committee

Yes

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

IPD Sharing Statement ^ICMJE

Plan to Share IPD:	Yes
Plan Description:	expected to be shared as an article paper after the trial ends
Supporting Materials:	Study Protocol
Supporting Materials:	Statistical Analysis Plan (SAP)
Supporting Materials:	Clinical Study Report (CSR)
Time Frame:	expected to be shared as an article paper after the trial ends

Current Responsible Party

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Original Responsible Party

Same as current

Current Study Sponsor ^ICMJE

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Original Study Sponsor ^ICMJE

Same as current

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:	Jie He, MD	Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
Principal Investigator:	Yin Li, MD	Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College

PRS Account

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Verification Date

April 2022

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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