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

Sponsor
Keio University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04699994
Collaborator
(none)
60
Enrollment
1
Location
1
Arm
52.2
Anticipated Duration (Months)
1.1
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: FLOT therapy
 Phase 2

Study Design

Study Type:
Interventional
Anticipated 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 :
Jun 25, 2020
Anticipated Primary Completion Date :
Oct 31, 2024
Anticipated Study Completion Date :
Oct 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: FLOT therapy

Drug: FLOT therapy
Preoperative FLOT therapy

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

  1. Response rate [2.5 years]

  2. Histological complete response rate [2.5 years]

  3. Treatment completion rate [2.5 years]

  4. Curative resection rate [2.5 years]

  5. Recurrence free survival [4.5 years]

  6. Overall survival [4.5 years]

  7. Incidence rate of adverse event during FLOT [2.5 years]

  8. Perioperative complication rate [2.5 years]

  9. Late phase complication rate [4.5 years]

  10. Incidence rate of severe adverse event [2.5 years]

  11. Incidence rate of all adverse event [4.5 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Keio University Hospital Tokyo Japan 1608582

Sponsors and Collaborators

  • Keio University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hirofumi Kawakubo, Associate Professor, Keio University
ClinicalTrials.gov Identifier:
NCT04699994
Other Study ID Numbers:
  • N20190007
First Posted:
Jan 7, 2021
Last Update Posted:
Aug 17, 2022
Last Verified:
Aug 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Carcinoma
Carcinoma, Squamous Cell
Esophageal Squamous Cell Carcinoma

Study Results

No Results Posted as of Aug 17, 2022