Surgery or Chemoradiotherapy for Cervical Esophageal Cancer

Not Applicable

Recruiting

• Conditions: Cervical Esophageal Cancer
• Interventions: Procedure: Esophagectomy

• Registration Number: NCT05327517
• Lead Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-04
• Study First Submitted: 2022-04-07
• Study First Submitted QC: 2022-04-07
• Last Update Submitted: 2022-04-07
• Study Start: 2022-04-10
• Study First Posted: 2022-04-14
• Last Update Posted: 2022-04-14
• Primary Completion: 2028-12-31
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 192

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Surgery	Esophagectomy	Patients receive esophagectomy or neoadjuvant therapy plus esophagectomy
Definitive chemoradiotherapy	Esophagectomy	Patients receive definitive chemoradiotherapy

Primary Outcome Measures

Name	Time	Method
Overall Survival	5 years after surgery or definitive Chemoradiotherapy is completed	5 year overall survival

Secondary Outcome Measures

Name	Time	Method
Laryngo-esophageal dysfunction free survival	5 years after surgery or definitive Chemoradiotherapy is completed	5 year laryngo-esophageal dysfunction free survival

Trial Locations

Locations (1)

Cancer Hospital Chinese Academy of Medical Sciences; 🇨🇳 Beijing, China