Surgery or Chemoradiotherapy for Cervical Esophageal Cancer

Chinese Academy of Medical Sciences & Peking Union Medical College

Status: Enrolling

Conditions: Cervical Esophageal Cancer

Treatments: Procedure: Esophagectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT05327517

NCC3281

Details and patient eligibility

About

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

Enrollment: 192 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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192 participants in 2 patient groups

Surgery

Experimental group

Description:

Patients receive esophagectomy or neoadjuvant therapy plus esophagectomy

Treatment:

Procedure: Esophagectomy

Definitive chemoradiotherapy

Active Comparator group

Description:

Patients receive definitive chemoradiotherapy

Treatment:

Procedure: Esophagectomy