Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05327517

Surgery or Chemoradiotherapy for Cervical Esophageal Cancer

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

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Cervical Esophageal Cancer Digestive System Diseases Digestive System Neoplasms Esophageal Diseases Esophageal Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Neoplasms Neoplasms by Site

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, China

Location status: Recruiting

Location contact

Yin Li, MD

CONTACT

[email protected]

861087788052

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Esophagectomy

Procedure

Patients receive esophagectomy or definitive chemoradiotherapy according to patient preference

Other names: Definitive chemoradiotherapy

Primary outcomes

  1. Overall Survival

    Time frame: 5 years after surgery or definitive Chemoradiotherapy is completed

    5 year overall survival

Secondary outcomes

  1. Laryngo-esophageal dysfunction free survival

    Time frame: 5 years after surgery or definitive Chemoradiotherapy is completed

    5 year laryngo-esophageal dysfunction free survival

Study contacts

Contact information is provided by the study sponsor or research team.

Zhen Wang, MD

CONTACT

[email protected]

+8613600892432

Sponsors and collaborators

Lead sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2028
Study completion
2028
First posted
Apr 14, 2022
Registry last updated
Apr 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.