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

Keio University

Status and phase: Enrolling; Phase 2

Conditions: Esophageal Squamous Cell Carcinoma

Treatments: Drug: FLOT therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04699994

N20190007

Details and patient eligibility

About

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

Enrollment: 60 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

FLOT therapy

Experimental group

Treatment:

Drug: FLOT therapy