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

Esophageal Squamous Cell Carcinoma Clinical Trial

Official title:

Multicenter Phase II Trial to Evaluate the Safety and Efficacy of FLOT Therapy for Resectable Esophageal Squamous Cell Carcinoma (Preoperative FLOT PII)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04699994
• Other study ID #: N20190007
• Status: Recruiting
• Phase: Phase 2
• Start date: June 25, 2020
• Est. completion date: October 31, 2024

Study information

• Verified date: August 2022
• Source: Keio University
• Contact: Satoru Matsuda
• Phone: +81333531211
• Email: s.matsuda.a8[@]keio.jp
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: October 31, 2024
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Esophageal Squamous Cell Carcinoma

Intervention

Drug:
• FLOT therapy
Preoperative FLOT therapy

Locations

Country	Name	City	State
Japan	Keio University Hospital	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Keio University

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Histological response rate (Grade 2 or 3 in Japanese Classification of Esophageal Cancer, 11th Edition)		2.5 years
Secondary	Response rate		2.5 years
Secondary	Histological complete response rate		2.5 years
Secondary	Treatment completion rate		2.5 years
Secondary	Curative resection rate		2.5 years
Secondary	Recurrence free survival		4.5 years
Secondary	Overall survival		4.5 years
Secondary	Incidence rate of adverse event during FLOT		2.5 years
Secondary	Perioperative complication rate		2.5 years
Secondary	Late phase complication rate		4.5 years
Secondary	Incidence rate of severe adverse event		2.5 years
Secondary	Incidence rate of all adverse event		4.5 years