Actively Recruiting
Postoperative Radiotherapy in Thoracic Esophageal Squamous Cell Carcinoma With Neoadjuvant Chemoradiotherapy
Led by Fujian Medical University Union Hospital · Updated on 2023-09-25
537
Participants Needed
1
Research Sites
296 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The primary objective is to compare surgery with postoperative radiotherapy (PORT) versus surgery, in terms of the overall survival time (OS) in Stage II or III squamous cell esophageal carcinoma with neoadjuvant chemoradiotherapy(nCRT).
CONDITIONS
Official Title
Postoperative Radiotherapy in Thoracic Esophageal Squamous Cell Carcinoma With Neoadjuvant Chemoradiotherapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must have histologically confirmed squamous cell carcinoma of the esophagus
- Tumors located in the thoracic cavity
- Pre-treatment stage II or III (AJCC/UICC 8th Edition)
- Male or non-pregnant female
- Age between 18 and 65 years
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1 or Karnofsky performance status (KPS) of 70 or higher
- Adequate bone marrow function: White Blood Cells ≥4x10^9/L; Neutrophils ≥1.5x10^9/L; Hemoglobin ≥90 g/L; Platelets ≥100x10^9/L
- Adequate liver function: Total bilirubin, AST and ALT ≤2 times upper limit of normal
- Adequate renal function: Serum creatinine ≤1.5 times upper limit of normal
- Provided written informed consent and able to understand and comply with the study
You will not qualify if you...
- Non-squamous cell carcinoma histology
- Advanced inoperable or metastatic esophageal cancer
- Another previous or current malignant disease
- Significant medical conditions unlikely to tolerate therapies, such as cardiac disease
- Age over 65 years
- Pregnant or lactating females or those unwilling to use contraceptives
- Uncontrolled seizures or psychiatric diseases with loss of behavioral control
- Refusal of surgery after neoadjuvant chemotherapy
- Considered unsuitable for trial enrollment by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Fujian Medical University Union Hospital
Fuzhou, Fujian, China, 350000
Actively Recruiting
Research Team
B
Benhua Xu, doctor
CONTACT
J
Jianyuan Song, doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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