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Surgery or Chemoradiotherapy for Cervical Esophageal Cancer

Sponsor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences (Other)
Overall Status
Recruiting
CT.gov ID
NCT05327517
Collaborator
(none)
192
Enrollment
1
Location
2
Arms
80.7
Anticipated Duration (Months)
2.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Procedure: Esophagectomy
 N/A

Study Design

Study Type:
Interventional
Anticipated 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
Anticipated Study Start Date :
Apr 10, 2022
Anticipated Primary Completion Date :
Dec 31, 2028
Anticipated Study Completion Date :
Dec 31, 2028

Arms and Interventions

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 Names:
  • Definitive chemoradiotherapy

    		•
    Active Comparator: Definitive chemoradiotherapy

    Patients receive definitive chemoradiotherapy

    Procedure: Esophagectomy
    Patients receive esophagectomy or definitive chemoradiotherapy according to patient preference
    Other Names:
  • Definitive chemoradiotherapy

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Overall Survival [5 years after surgery or definitive Chemoradiotherapy is completed]

      5 year overall survival

    Secondary Outcome Measures

    1. Laryngo-esophageal dysfunction free survival [5 years after surgery or definitive Chemoradiotherapy is completed]

      5 year laryngo-esophageal dysfunction free survival

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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 >=4.0x109/L; Absolute neutrophil count >=1.5x109/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

    Locations

    Site City State Country Postal Code
    1 Cancer Hospital Chinese Academy of Medical Sciences Beijing China

    Sponsors and Collaborators

    • Cancer Institute and Hospital, Chinese Academy of Medical Sciences

    Investigators

    • 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Cancer Institute and Hospital, Chinese Academy of Medical Sciences
    ClinicalTrials.gov Identifier:
    NCT05327517
    Other Study ID Numbers:
    • NCC3281
    First Posted:
    Apr 14, 2022
    Last Update Posted:
    Apr 14, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    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:
    Esophageal Neoplasms

    Study Results

    No Results Posted as of Apr 14, 2022