Surgery or Chemoradiotherapy for Cervical Esophageal Cancer

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

Status

Recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05327517

Enrollment

192

Registered

2022-04-14

Start date

2022-04-10

Completion date

2028-12-31

Last updated

2022-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical Esophageal Cancer

Keywords

Esophageal neoplasm, Chemoradiotherapy, Esophagectomy, Overall survival

Brief summary

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

Interventions

PROCEDUREEsophagectomy

Patients receive esophagectomy or definitive chemoradiotherapy according to patient preference

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Overall Survival	5 years after surgery or definitive Chemoradiotherapy is completed	5 year overall survival

Secondary

Measure	Time frame	Description
Laryngo-esophageal dysfunction free survival	5 years after surgery or definitive Chemoradiotherapy is completed	5 year laryngo-esophageal dysfunction free survival

Countries

China

Contacts

Primary ContactZhen Wang, MD

wangzhen@cicams.ac.cn+8613600892432

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026