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

Phase 2

Recruiting

• Conditions: Esophageal Squamous Cell Carcinoma
• Interventions: Drug: FLOT therapy

• Registration Number: NCT04699994
• Lead Sponsor: Keio University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-06-25
• Study First Submitted: 2021-01-05
• Study First Submitted QC: 2021-01-05
• Study First Posted: 2021-01-07
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-15
• Last Update Posted: 2022-08-17
• Primary Completion: 2024-10-31
• Study Completion: 2024-10-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
FLOT therapy	FLOT therapy	-

Primary Outcome Measures

Name	Time	Method
Histological response rate (Grade 2 or 3 in Japanese Classification of Esophageal Cancer, 11th Edition)	2.5 years

Secondary Outcome Measures

Name	Time	Method
Perioperative complication rate	2.5 years
Late phase complication rate	4.5 years
Incidence rate of all adverse event	4.5 years
Incidence rate of adverse event during FLOT	2.5 years
Incidence rate of severe adverse event	2.5 years
Response rate	2.5 years
Treatment completion rate	2.5 years
Histological complete response rate	2.5 years
Curative resection rate	2.5 years
Recurrence free survival	4.5 years
Overall survival	4.5 years

Trial Locations

Locations (1)

Keio University Hospital; 🇯🇵 Tokyo, Japan