Prospective Trial to Evaluate the Safety and Efficacy to Treat Esophageal Cancer Using 5-FU, Oxaliplatin, and Docetaxel

Study Overview
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Brief Summary
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The current multicenter prospective phase II study aims to evaluate the safety and efficacy of preoperative FLOT therapy for esophageal squamous cell carcinoma.

Official Title
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Multicenter Phase II Trial to Evaluate the Safety and Efficacy of FLOT Therapy for Resectable Esophageal Squamous Cell Carcinoma (Preoperative FLOT PII)

Conditions
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Esophageal Squamous Cell Carcinoma

Intervention / Treatment
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* Drug: FLOT therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically diagnosed as esophageal squamous cell carcinoma (squamous, adenosquamous, basaloid) Primary tumor is located mainly in the thoracic esophagus cT1N1-3M0-1 (only supraclavicular LN metastasis is included as M1), cT2-3N0-3M0-1 (only supraclavicular LN metastasis is included as M1) Twenty years old or older as of registration Performance status (PS) 0 or 1 Patients have target lesions No previous history of esophageal cancer except for the followings 1) pT1a-LPM (M2) or deeper following EMR/ESD 2) pT1a-MM (M3) with vascular invasion following EMR/ ESD 8. No previous history of chemotherapy/radiotherapy/endocrine therapy except for hormone therapy for prostate cancer after 5 years interval 9. Patients who meet the following criteria Neutrophil > 1,500 /mm3 Platelet > 10.0x10^4 /mm3 Hb ≧9.0 g/dL Total bilirubin ≦ 1.5 mg/dL AST ≦ 100 IU/L ALT ≦ 100 IU/L SpO2 ≧ 95 % Creatinine clearance ≧ 50 mL/min 10. Patients who can undergo esophagectomy 11. Agree with the participation to the current study Exclusion Criteria: Patients who received any treatment for cancer within 3 years Patients who have active infectious diseases HBs Ag positive or HIV Ab positive Pregnant or breast feeding Patients with psychological disorder On systemic steroid therapy Require flucytocine, phenytoin, warfarin Allergic to iodine Allergic to DTX, LOHP, polisorbate 80 Uncontrollable diabetes Severe COPD or lung fibrosis Severe hypertension Unstable angina Patients whom investigators evaluate as ineligible

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FLOT therapy<br> | Drug: FLOT therapy<br>* Preoperative FLOT therapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Histological response rate (Grade 2 or 3 in Japanese Classification of Esophageal Cancer, 11th Edition) |  | 2.5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate |  | 2.5 years | 
| Histological complete response rate |  | 2.5 years | 
| Treatment completion rate |  | 2.5 years | 
| Curative resection rate |  | 2.5 years | 
| Recurrence free survival |  | 4.5 years | 
| Overall survival |  | 4.5 years | 
| Incidence rate of adverse event during FLOT |  | 2.5 years | 
| Perioperative complication rate |  | 2.5 years | 
| Late phase complication rate |  | 4.5 years | 
| Incidence rate of severe adverse event |  | 2.5 years | 
| Incidence rate of all adverse event |  | 4.5 years |