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

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ClinicalTrials.gov Identifier: NCT04699994
Recruitment Status : Recruiting
First Posted : January 7, 2021
Last Update Posted : January 8, 2021
Sponsor:
Information provided by (Responsible Party):
Hirofumi Kawakubo, Keio University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Esophageal Squamous Cell Carcinoma Drug: FLOT therapy Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multicenter Phase II Trial to Evaluate the Safety and Efficacy of FLOT Therapy for Resectable Esophageal Squamous Cell Carcinoma (Preoperative FLOT PII)
Actual Study Start Date : June 25, 2020
Estimated Primary Completion Date : October 31, 2024
Estimated Study Completion Date : October 31, 2024

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Arms and Interventions
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Arm Intervention/treatment
Experimental: FLOT therapy Drug: FLOT therapy
Preoperative FLOT therapy


Outcome Measures
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Primary Outcome Measures :
  1. Histological response rate (Grade 2 or 3 in Japanese Classification of Esophageal Cancer, 11th Edition) [ Time Frame: 2.5 years ]

Secondary Outcome Measures :
  1. Response rate [ Time Frame: 2.5 years ]
  2. Histological complete response rate [ Time Frame: 2.5 years ]
  3. Treatment completion rate [ Time Frame: 2.5 years ]
  4. Curative resection rate [ Time Frame: 2.5 years ]
  5. Recurrence free survival [ Time Frame: 4.5 years ]
  6. Overall survival [ Time Frame: 4.5 years ]
  7. Incidence rate of adverse event during FLOT [ Time Frame: 2.5 years ]
  8. Perioperative complication rate [ Time Frame: 2.5 years ]
  9. Late phase complication rate [ Time Frame: 4.5 years ]
  10. Incidence rate of severe adverse event [ Time Frame: 2.5 years ]
  11. Incidence rate of all adverse event [ Time Frame: 4.5 years ]

Eligibility Criteria
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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04699994


Contacts
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Contact: Satoru Matsuda +81333531211 s.matsuda.a8@keio.jp

Locations
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Japan
Keio University Hospital Recruiting
Tokyo, Japan, 1608582
Contact: Satoru Matsuda    +81333531211    s.matsuda.a8@keio.jp   
Sponsors and Collaborators
Keio University
More Information
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Responsible Party: Hirofumi Kawakubo, Associate Professor, Keio University
ClinicalTrials.gov Identifier: NCT04699994    
Other Study ID Numbers: N20190007
First Posted: January 7, 2021    Key Record Dates
Last Update Posted: January 8, 2021
Last Verified: January 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Squamous Cell
Esophageal Squamous Cell Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Esophageal Neoplasms
 Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases