Status:
UNKNOWN
Prospective Trial to Evaluate the Safety and Efficacy to Treat Esophageal Cancer Using 5-FU, Oxaliplatin, and Docetaxel
Lead Sponsor:
Keio University
Conditions:
Esophageal Squamous Cell Carcinoma
Eligibility:
All Genders
20+ years
Phase:
PHASE2
Brief Summary
The current multicenter prospective phase II study aims to evaluate the safety and efficacy of preoperative FLOT therapy for esophageal squamous cell carcinoma.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 25 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 31 2024
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04699994
Start Date
June 25 2020
End Date
October 31 2024
Last Update
August 17 2022
Active Locations (1)
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1
Keio University Hospital
Tokyo, Japan, 1608582