Status:
RECRUITING
Surgery or Chemoradiotherapy for Cervical Esophageal Cancer
Lead Sponsor:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Conditions:
Cervical Esophageal Cancer
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
To compare surgery with definitive chemoradiotherapy for patients with resectable cervical esophageal squamous cell carcinoma.
Eligibility Criteria
Inclusion
- 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
- Without other malignancies;
- With mental diseases;
- With hemorrhagic disease;
- Inoperable patients;
- Pregnant or lactating women;
- Has a history of allergy to paclitaxel or cisplatin
Key Trial Info
Start Date :
April 10 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2028
Estimated Enrollment :
192 Patients enrolled
Trial Details
Trial ID
NCT05327517
Start Date
April 10 2022
End Date
December 31 2028
Last Update
April 14 2022
Active Locations (1)
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1
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, China