Actively Recruiting
A Prospective Randomized Controlled Clinical Study Comparing Radical Chemoradiotherapy Alone and Combined With Consolidation Chemotherapy for Non-surgical Esophageal Squamous Cell Carcinoma
Led by The First Affiliated Hospital with Nanjing Medical University · Updated on 2023-03-20
1216
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating treatments for esophageal squamous cell carcinoma, focusing on patients who cannot have surgery or refuse it. This phase III, multicenter, prospective randomized controlled study compares radical chemoradiotherapy alone versus combined with consolidation chemotherapy, aiming to observe and compare survival times and side effects. The study targets tumors classified from stage T2N0M0 to TxNxM0 according to the 2017 AJCC staging criteria. Participants are assigned to one of two groups. Group A receives radical chemoradiotherapy, which includes concurrent chemotherapy using Lipusu (T) and Cisplatin (DDP) over two cycles, alongside intensity modulated radiotherapy. Group B receives the same initial treatment followed by four cycles of consolidation chemotherapy after a rest period of 2 to 3 weeks. Radiotherapy doses range from 50 to 60 Gy using conventional fractionation. During the study, participants undergo assessments for overall survival at 3 and 5 years, as well as progression-free survival, objective response rate, disease control rate, side effects, and quality of life. Researchers monitor safety, side effects, and treatment responses over the course of the study, which lasts several years. Participants are followed closely to evaluate these outcomes and the impact of treatments on their health.
CONDITIONS
Brief Title
Comparison of Chemoradiotherapy and Chemoradiotherapy Combined With Consolidation Chemotherapy for ESCC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 70 years, any gender, and able to take liquid diet
- Diagnosis of esophageal squamous cell carcinoma confirmed by histopathology
- Tumor stage T2N0M0 to TxNxM0 according to the 2017 8th edition AJCC criteria
- Inoperable tumor or patient refuses surgery
- ECOG performance status 0-1 with life expectancy greater than 6 months
- No prior chemotherapy or radiotherapy
- No surgical treatment
- No serious allergy history
- Adequate blood counts and liver function tests
- Ability to understand the study and provide informed consent
You will not qualify if you...
- History of malignant tumors in other parts
- Multiple esophageal carcinomas
- Pregnant or lactating women
- Fertile patients not using contraception
- Serious comorbidities including very high-risk hypertension, severe lung impairment, recent major heart attack, cardiac function grade II or higher, severe diabetes, or mental illness
- Active infectious diseases
- Participation in other clinical trials currently or within 4 weeks
- Use of other anti-cancer drugs, including traditional Chinese medicine
- Previous esophageal stent placement
- Tendency for perforation
- History of organ transplantation
- Widespread metastases including lung, liver, bone, or brain
- Known or suspected allergy to chemotherapy drugs
- Any condition that may endanger safety or affect study completion as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 18 to 24 weeks including concurrent chemotherapy, radiotherapy, rest period, and consolidation chemotherapy if assigned
Participants receive radical chemoradiotherapy consisting of concurrent chemotherapy with Lipusu and Cisplatin over 2 cycles combined with intensity modulated radiotherapy. Some participants may also receive consolidation chemotherapy of 4 additional cycles after a 2-3 week rest period following concurrent chemoradiotherapy.
Multiple visits for chemotherapy and radiotherapy treatments over several weeks
Duration - Up to 5 years
Participants are followed to assess survival, disease progression, and quality of life after treatment completion.
Regular visits for up to 5 years to monitor health status
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
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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