Clinical trial · Interventional
Prospective Trial to Evaluate the Safety and Efficacy to Treat Esophageal Cancer Using 5-FU, Oxaliplatin, and Docetaxel
Multicenter Phase II Trial to Evaluate the Safety and Efficacy of FLOT Therapy for Resectable Esophageal Squamous Cell Carcinoma (Preoperative FLOT PII)
NCT04699994CI-TRIAL-00060368unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The current multicenter prospective phase II study aims to evaluate the safety and efficacy of preoperative FLOT therapy for esophageal squamous cell carcinoma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophageal Squamous Cell Carcinoma | Esophageal Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| FLOT therapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- FLOT therapy
- interventionNames
- Drug: FLOT therapy
Primary outcomes (1)
- measure
- Histological response rate (Grade 2 or 3 in Japanese Classification of Esophageal Cancer, 11th Edition)
- timeFrame
- 2.5 years
Secondary outcomes (11)
- measure
- Response rate
- timeFrame
- 2.5 years
- measure
- Histological complete response rate
- timeFrame
- 2.5 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.