Esophageal squamous cell carcinoma Esophageal squamous cell carcinoma
Conditions
Interventions
FLOT therapy for 4 cycles as neoadjuvant chemotherapy followed by transthoracic esophagectomy
Sponsors
Kawakubo Hirofumi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histologically diagnosed as esophageal squamous cell carcinoma (squamous, adenosquamous, basaloid) 2. Primary tumor is located mainly in the thoracic esophagus 3. cT1N1-3M0-1 (only supraclavicular LN metastasis is included as M1), cT2-3N0-3M0-1 (only supraclavicular LN metastasis is included as M1) 4. Twenty years old or older as of registration 5. Performance status (PS) 0 or 1 6. Patients have target lesions 7. 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 1) Neutrophil>1,500 /mm3 2) Platelet>10.0x10^4 /mm3 3) Hb>=9.0 g/dL 4) Total bilirubin=95 % 8) Creatinine clearance<=50 mL/min 10. Patients who can undergo esophagectomy 11. Agree with the participation to the current study
Exclusion criteria
Exclusion criteria: 1. Patients who received any treatment for cancer within 3 years 2. Patients who have active infectious diseases 3. HBs Ag positive or HIV Ab positive 4. Pregnant or breast feeding 5. Patients with psychological disorder 6. On systemic steroid therapy 7. Require flucytocine, phenytoin, warfarin 8. Allergic to iodine 9. Allergic to DTX, LOHP, polisorbate 80 10. Uncontrollable diabetes 11. Severe COPD or lung fibrosis 12. Severe hypertension 13. Unstable angina 14. Patients whom investigators evaluate as ineligible
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Histological response rate (Grade 2 or 3 in Japanese Classification of Esophageal Cancer, 11th Edition) | — |
Secondary
| Measure | Time frame |
|---|---|
| Response rate, histological complete response rate, treatment completion rate, curative resection rate, recurrence free survival, overall survival, incidence rate of adverse event during FLOT, perioperative complication rate, late phase complication rate, incidence rate of severe adverse event, incidence rate of all adverse event | — |
Contacts
Public ContactSatoru Matsuda
Department of Surgery, Keio University School of Medicine
Outcome results
None listed