"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.
Study 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 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
Eligibility
Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
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
Primary outcome measure(s)
Overall response rate of the treatment — At week 8, week 16, and 4 weeks after completion of concurrent chemoradiotherapy (CCRT). Overall response rate = complete response (CR) rate + partial response (PR) rate.
Duration of response (DOR) — At week 8, week 16, and 4 weeks after completion of CCRT. Thereafter, every 3 months. Defined as the time from CR or PR to the time of disease progression or death.
Trial sites (1)
Facility
City
Region
Status
National Cheng Kung University Hospital
Tainan
Taiwan
Recruiting
More National Cheng-Kung University Hospital trials in Taiwan
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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