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)

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

Study Overview

• Status: Recruiting
• Conditions: Esophageal Squamous Cell Carcinoma
• Intervention / Treatment: Drug: FLOT therapy

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Satoru Matsuda; Phone Number: +81333531211; Email: s.matsuda.a8@keio.jp

Study Locations

• Japan
  • Tokyo, Japan, 1608582
    • Recruiting
    • Keio University Hospital
    • Contact: Satoru Matsuda; Phone Number: +81333531211; Email: s.matsuda.a8@keio.jp

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: FLOT therapy	Drug: FLOT therapy; Preoperative FLOT therapy

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
Response rate	2.5 years
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
Incidence rate of adverse event during FLOT	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

Collaborators and Investigators

• Sponsor: Keio University

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 25, 2020
• Primary Completion (ANTICIPATED): October 31, 2024
• Study Completion (ANTICIPATED): October 31, 2024

Study Registration Dates

• First Submitted: January 5, 2021
• First Submitted That Met QC Criteria: January 5, 2021
• First Posted (ACTUAL): January 7, 2021

Study Record Updates

• Last Update Posted (ACTUAL): August 17, 2022
• Last Update Submitted That Met QC Criteria: August 15, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Head and Neck Neoplasms; Esophageal Diseases; Neoplasms, Squamous Cell; Esophageal Neoplasms; Carcinoma; Carcinoma, Squamous Cell; Esophageal Squamous Cell Carcinoma
• Other Study ID Numbers: N20190007

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No