RecruitingNot ApplicableNCT05327517
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
Sponsor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Enrollment
192 participants
Start Date
Apr 10, 2022
Study Type
INTERVENTIONAL
Conditions
Summary
To compare surgery with definitive chemoradiotherapy for patients with resectable cervical esophageal squamous cell carcinoma.
Eligibility
Min Age: 18 YearsMax Age: 75 Years
Inclusion Criteria9
- 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 Criteria6
- Without other malignancies;
- With mental diseases;
- With hemorrhagic disease;
- Inoperable patients;
- Pregnant or lactating women;
- Has a history of allergy to paclitaxel or cisplatin
Interventions
PROCEDUREEsophagectomy
Patients receive esophagectomy or definitive chemoradiotherapy according to patient preference
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05327517