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RecruitingPhase 1Phase 2NCT06531434

Establishing Best Treatment Strategy for T4 Esophageal Cancer

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

Sponsor

National Cheng-Kung University Hospital

Enrollment

22 participants

Start Date

Aug 1, 2024

Study Type

INTERVENTIONAL

Conditions

Esophageal Cancer TNM Staging Primary Tumor (T) T4

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

Min Age: 18 YearsMax Age: 70 Years

Inclusion Criteria5

  • 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 Criteria7

  • 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

Interventions

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

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NCT06531434