Actively Recruiting
Comparison of Chemoradiotherapy and Chemoradiotherapy Combined With Consolidation Chemotherapy for ESCC
Led by The First Affiliated Hospital with Nanjing Medical University · Updated on 2023-03-20
1216
Participants Needed
1
Research Sites
365 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is a phase III, multicenter, prospective randomized controlled clinical study comparing the efficacy of non-surgical esophageal squamous cell carcinoma with radical chemoradiotherapy and radical chemoradiotherapy combined with consolidation chemotherapy. The survival time and side effects of patients were observed and compared.
CONDITIONS
Official Title
Comparison of Chemoradiotherapy and Chemoradiotherapy Combined With Consolidation Chemotherapy for ESCC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18-70 years old, male or female; able to take at least a liquid diet
- Histopathology-confirmed esophageal squamous cell carcinoma
- Esophageal squamous cell carcinoma that is inoperable or patient refuses surgery
- Tumor stage T2N0M0 to TxNxM0 according to 2017 8th edition AJCC staging
- ECOG performance status 0-1; life expectancy greater than 6 months
- No prior chemotherapy
- No prior radiotherapy
- No prior surgical treatment
- No serious allergic history
- Blood counts and liver function within specified limits
- Able to understand the study and sign informed consent
You will not qualify if you...
- History of malignant tumors in other parts of the body
- Duplicate carcinoma of the esophagus
- Pregnant or lactating patients
- Fertile patients not using contraceptive measures
- Serious comorbidities including very high-risk hypertension, severe lung impairment, major heart attack, cardiac function grade II or higher, mental illness, severe diabetes
- Active infectious diseases
- Participation in other clinical trials currently or within 4 weeks before enrollment
- Simultaneous treatment with other anti-cancer drugs including traditional Chinese medicine
- History of esophageal stent placement
- Cases with tendency for perforation
- History of organ transplantation
- Widespread metastases including lung, liver, bone, or brain
- Known or suspected allergy to chemotherapy drugs
- Other diseases that endanger safety or study completion as judged by investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China, 210009
Actively Recruiting
Research Team
X
Xiaolin GE, MM
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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