NCT04699994
Recruiting
Phase 2
Multicenter Phase II Trial to Evaluate the Safety and Efficacy of FLOT Therapy for Resectable Esophageal Squamous Cell Carcinoma (Preoperative FLOT PII)
Overview
- Phase
- Phase 2
- Intervention
- FLOT therapy
- Conditions
- Esophageal Squamous Cell Carcinoma
- Sponsor
- Keio University
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Histological response rate (Grade 2 or 3 in Japanese Classification of Esophageal Cancer, 11th Edition)
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
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.
Investigators
Hirofumi Kawakubo
Associate Professor
Keio University
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
- •pT1a-LPM (M2) or deeper following EMR/ESD 2) pT1a-MM (M3) with vascular invasion following EMR/ ESD
- •No previous history of chemotherapy/radiotherapy/endocrine therapy except for hormone therapy for prostate cancer after 5 years interval
- •Patients who meet the following criteria
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
Arms & Interventions
FLOT therapy
Intervention: FLOT therapy
Outcomes
Primary Outcomes
Histological response rate (Grade 2 or 3 in Japanese Classification of Esophageal Cancer, 11th Edition)
Time Frame: 2.5 years
Secondary Outcomes
- Late phase complication rate(4.5 years)
- Incidence rate of all adverse event(4.5 years)
- Incidence rate of adverse event during FLOT(2.5 years)
- Incidence rate of severe adverse event(2.5 years)
- Response rate(2.5 years)
- Treatment completion rate(2.5 years)
- Perioperative complication rate(2.5 years)
- Histological complete response rate(2.5 years)
- Curative resection rate(2.5 years)
- Recurrence free survival(4.5 years)
- Overall survival(4.5 years)
Study Sites (1)
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