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Surgery or Chemoradiotherapy for Cervical Esophageal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05327517
Recruitment Status : Recruiting
First Posted : April 14, 2022
Last Update Posted : April 14, 2022
Sponsor:
Information provided by (Responsible Party):
Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study Description
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Brief Summary:
To compare surgery with definitive chemoradiotherapy for patients with resectable cervical esophageal squamous cell carcinoma.

Condition or disease Intervention/treatment Phase
Cervical Esophageal Cancer Procedure: Esophagectomy Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 192 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Surgery Versus Definitive Chemoradiotherapy for Resectable Cervical Esophageal Squamous Cell Carcinoma: A Prospective Multicenter Open-Label Clinical Trial
Estimated Study Start Date : April 10, 2022
Estimated Primary Completion Date : December 31, 2028
Estimated Study Completion Date : December 31, 2028

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Surgery
Patients receive esophagectomy or neoadjuvant therapy plus esophagectomy
 Procedure: Esophagectomy
Patients receive esophagectomy or definitive chemoradiotherapy according to patient preference
Other Name: Definitive chemoradiotherapy
Active Comparator: Definitive chemoradiotherapy
Patients receive definitive chemoradiotherapy
 Procedure: Esophagectomy
Patients receive esophagectomy or definitive chemoradiotherapy according to patient preference
Other Name: Definitive chemoradiotherapy


Outcome Measures
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Primary Outcome Measures :
  1. Overall Survival [ Time Frame: 5 years after surgery or definitive Chemoradiotherapy is completed ]
    5 year overall survival


Secondary Outcome Measures :
  1. Laryngo-esophageal dysfunction free survival [ Time Frame: 5 years after surgery or definitive Chemoradiotherapy is completed ]
    5 year laryngo-esophageal dysfunction free survival


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

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05327517


Contacts
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Contact: Zhen Wang, MD +8613600892432 wangzhen@cicams.ac.cn

Locations
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China
Cancer Hospital Chinese Academy of Medical Sciences Recruiting
Beijing, China
Contact: Yin Li, MD    861087788052    liyin@cicams.ac.cn   
Sponsors and Collaborators
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Investigators
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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
More Information
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Responsible Party: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier: NCT05327517    
Other Study ID Numbers: NCC3281
First Posted: April 14, 2022    Key Record Dates
Last Update Posted: April 14, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: expected to be shared as an article paper after the trial ends
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: expected to be shared as an article paper after the trial ends

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Cancer Institute and Hospital, Chinese Academy of Medical Sciences:
Esophageal neoplasm
Chemoradiotherapy
Esophagectomy
Overall survival
Additional relevant MeSH terms:
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Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases