Status:
RECRUITING
Establishing Best Treatment Strategy for T4 Esophageal Cancer
Lead Sponsor:
National Cheng-Kung University Hospital
Conditions:
Esophageal Cancer TNM Staging Primary Tumor (T) T4
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
PHASE2
Brief Summary
The goal of this clinical trial is to investigate the safety and efficacy of a new treatment approach for T4-stage esophageal cancer, which involves chemoradiotherapy after induction chemotherapy. The...
Detailed Description
The treatment of T4-stage esophageal cancer is challenging because of a high esophageal perforation rate (19%) after concurrent chemoradiotherapy. This research aims to investigate whether a novel seq...
Eligibility Criteria
Inclusion
- Histologically confirmed esophageal squamous cell carcinoma
- Tumor or lymph nodes invade adjacent organs (T4 stage)
- Aged between 18-70 years old
- Patient health status score Eastern Cooperative Oncology Group (ECOG) performance status (PS) \<2
- Hemoglobin ≥ 10 g/L, absolute neutrophil count ≥ 2×10\^3/L, platelet count ≥ 100×10\^9/L, total bilirubin ≤ 1.5 mg/L, serum transaminases ≤ 105 U/L, creatinine clearance ≥ 40 mL/min.
Exclusion
- Previous chemotherapy history
- Myocardial infarction within the last three months
- History of unstable angina, interstitial pneumonia, fibrotic lung disease, or severe emphysema
- Has other malignancies currently
- Uncontrolled infection
- Pregnancy or lactation
- Perforated esophagus at the time of diagnosis
Key Trial Info
Start Date :
August 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2026
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT06531434
Start Date
August 1 2024
End Date
April 30 2026
Last Update
September 22 2025
Active Locations (1)
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1
National Cheng Kung University Hospital
Tainan, Taiwan, Taiwan, 704302