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

Primary Purpose

Esophageal Squamous Cell Carcinoma

Status
Recruiting
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
FLOT therapy
Sponsored by
Keio University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophageal Squamous Cell Carcinoma

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Keio University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

FLOT therapy

Arm Description

Outcomes

Primary Outcome Measures

Histological response rate (Grade 2 or 3 in Japanese Classification of Esophageal Cancer, 11th Edition)

Secondary Outcome Measures

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

Full Information

First Posted
January 5, 2021
Last Updated
August 15, 2022
Sponsor
Keio University
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1. Study Identification

Unique Protocol Identification Number
NCT04699994
Brief Title
Prospective Trial to Evaluate the Safety and Efficacy to Treat Esophageal Cancer Using 5-FU, Oxaliplatin, and Docetaxel
Official Title
Multicenter Phase II Trial to Evaluate the Safety and Efficacy of FLOT Therapy for Resectable Esophageal Squamous Cell Carcinoma (Preoperative FLOT PII)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 25, 2020 (Actual)
Primary Completion Date
October 31, 2024 (Anticipated)
Study Completion Date
October 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Keio University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Squamous Cell Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
FLOT therapy
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
FLOT therapy
Intervention Description
Preoperative FLOT therapy
Primary Outcome Measure Information:
Title
Histological response rate (Grade 2 or 3 in Japanese Classification of Esophageal Cancer, 11th Edition)
Time Frame
2.5 years
Secondary Outcome Measure Information:
Title
Response rate
Time Frame
2.5 years
Title
Histological complete response rate
Time Frame
2.5 years
Title
Treatment completion rate
Time Frame
2.5 years
Title
Curative resection rate
Time Frame
2.5 years
Title
Recurrence free survival
Time Frame
4.5 years
Title
Overall survival
Time Frame
4.5 years
Title
Incidence rate of adverse event during FLOT
Time Frame
2.5 years
Title
Perioperative complication rate
Time Frame
2.5 years
Title
Late phase complication rate
Time Frame
4.5 years
Title
Incidence rate of severe adverse event
Time Frame
2.5 years
Title
Incidence rate of all adverse event
Time Frame
4.5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically diagnosed as esophageal squamous cell carcinoma (squamous, adenosquamous, basaloid) Primary tumor is located mainly in the thoracic esophagus cT1N1-3M0-1 (only supraclavicular LN metastasis is included as M1), cT2-3N0-3M0-1 (only supraclavicular LN metastasis is included as M1) Twenty years old or older as of registration Performance status (PS) 0 or 1 Patients have target lesions 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 Neutrophil > 1,500 /mm3 Platelet > 10.0x10^4 /mm3 Hb ≧9.0 g/dL Total bilirubin ≦ 1.5 mg/dL AST ≦ 100 IU/L ALT ≦ 100 IU/L SpO2 ≧ 95 % Creatinine clearance ≧ 50 mL/min 10. Patients who can undergo esophagectomy 11. Agree with the participation to the current study Exclusion Criteria: Patients who received any treatment for cancer within 3 years Patients who have active infectious diseases HBs Ag positive or HIV Ab positive Pregnant or breast feeding Patients with psychological disorder On systemic steroid therapy Require flucytocine, phenytoin, warfarin Allergic to iodine Allergic to DTX, LOHP, polisorbate 80 Uncontrollable diabetes Severe COPD or lung fibrosis Severe hypertension Unstable angina Patients whom investigators evaluate as ineligible
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Satoru Matsuda
Phone
+81333531211
Email
s.matsuda.a8@keio.jp
Facility Information:
Facility Name
Keio University Hospital
City
Tokyo
ZIP/Postal Code
1608582
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Satoru Matsuda
Phone
+81333531211
Email
s.matsuda.a8@keio.jp

12. IPD Sharing Statement

Learn more about this trial

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

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