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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Cancer Hospital Chinese Academy of Medical Sciences
RECRUITING
Beijing
Contact Information
Primary
Zhen Wang, MD
wangzhen@cicams.ac.cn
+8613600892432
Time Frame
Start Date: 2022-04-10
Estimated Completion Date: 2028-12-31
Participants
Target number of participants: 192
Treatments
Experimental: Surgery
Patients receive esophagectomy or neoadjuvant therapy plus esophagectomy
Active_comparator: Definitive chemoradiotherapy
Patients receive definitive chemoradiotherapy
Related Therapeutic Areas
Sponsors
Leads: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

This content was sourced from clinicaltrials.gov

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