Surgery or Chemoradiotherapy for Cervical Esophageal Cancer

Chinese Academy of Medical Sciences & Peking Union Medical College logo

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)

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

Trial contacts and locations

1

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Central trial contact

Zhen Wang, MD

Data sourced from clinicaltrials.gov

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