Prospective Trial to Evaluate the Safety and Efficacy to Treat Esophageal Cancer Using 5-FU, Oxaliplatin, and Docetaxel
NCT ID: NCT04699994
Last Updated: 2022-08-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
60 participants
INTERVENTIONAL
2020-06-25
2024-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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FLOT therapy
FLOT therapy
Preoperative FLOT therapy
Interventions
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FLOT therapy
Preoperative FLOT therapy
Eligibility Criteria
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Inclusion Criteria
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
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
20 Years
ALL
No
Sponsors
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Keio University
OTHER
Responsible Party
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Hirofumi Kawakubo
Associate Professor
Locations
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Keio University Hospital
Tokyo, , Japan
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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N20190007
Identifier Type: -
Identifier Source: org_study_id
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