Establishing Best Treatment Strategy for T4 Esophageal Cancer

Recruiting now · Phase 1/Phase 2

Conditions studied: Esophageal Cancer TNM Staging Primary Tumor (T) T4

In brief

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 main questions it aims to answer are: * Does the new induction chemotherapy followed by chemoradiation reduce esophageal perforation rate? * Does the new induction chemotherapy followed by chemoradiation increase treatment response rate and patient survival? Researchers will analyze the above data to see if the new treatment approach works to treat T4 esophageal cancer. Participants will: * Receive induction chemotherapy for 4 to 8 cycles, followed by chemoradiation therapy if downstage to T3 * Visit the clinic once every week for checkups and tests * Keep a diary of their symptoms

Key facts

Study ID

NCT06531434

Run by

National Cheng-Kung University Hospital

People needed

22

Starts

2024-08-01

Expected to finish

2026-04-30

Last updated by the study team

2025-09-22

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• National Cheng Kung University Hospital — Tainan, Taiwan, Taiwan (enrolling)

Full record on ClinicalTrials.gov

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