RECRUITINGPhase 1 / Phase 2INTERVENTIONAL

Establishing Best Treatment Strategy for T4 Esophageal Cancer

A Pilot Study to Establish Best Treatment Strategy for T4 Esophageal Cancer

About This Trial

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

Who May Be Eligible (Plain English)

Who May Qualify: 1. diagnosed by tissue sample (biopsy-confirmed) esophageal squamous cell carcinoma 2. Tumor or lymph nodes invade adjacent organs (T4 stage) 3. Aged between 18-70 years old 4. Patient health status score Eastern Cooperative Oncology Group (ECOG) performance status (PS) \<2 5. blood count (hemoglobin) at least 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, kidney function (creatinine clearance) at least 40 mL/min. Who Should NOT Join This Trial: 1. Previous chemotherapy history 2. Myocardial infarction within the last three months 3. History of unstable angina, interstitial pneumonia, fibrotic lung disease, or severe emphysema 4. Has other malignancies currently 5. Uncontrolled infection 6. Pregnancy or lactation 7. Perforated esophagus at the time of diagnosis Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: 1. Histologically confirmed esophageal squamous cell carcinoma 2. Tumor or lymph nodes invade adjacent organs (T4 stage) 3. Aged between 18-70 years old 4. Patient health status score Eastern Cooperative Oncology Group (ECOG) performance status (PS) \<2 5. 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 Criteria: 1. Previous chemotherapy history 2. Myocardial infarction within the last three months 3. History of unstable angina, interstitial pneumonia, fibrotic lung disease, or severe emphysema 4. Has other malignancies currently 5. Uncontrolled infection 6. Pregnancy or lactation 7. Perforated esophagus at the time of diagnosis

Treatments Being Tested

COMBINATION_PRODUCT

"Docetaxel", "Cisplatin", "fluorouracil", "Radiation"

Induction chemotherapy with Docetaxel, Cisplatin, and fluorouracil for 4 to 8 cycles, followed by concurrent chemoradiotherapy with Cisplatin and Radiation 30.6-40 Gy.

Locations (1)

National Cheng Kung University Hospital

Tainan, Taiwan, Taiwan