Esophageal Squamous Cell Carcinoma
Conditions
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.
Interventions
DRUGFLOT therapy
Preoperative FLOT therapy
Sponsors
Keio University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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 ≦ 1.5 mg/dL 5. AST ≦ 100 IU/L 6. ALT ≦ 100 IU/L 7. SpO2 ≧ 95 % 8. Creatinine clearance ≧ 50 mL/min 10. Patients who can undergo esophagectomy 11. Agree with the participation to the current study
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) | 2.5 years |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Response rate | 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 |
| Incidence rate of adverse event during FLOT | 2.5 years |
Countries
Japan
Contacts
Primary ContactSatoru Matsuda
Outcome results
None listed