Clinical trial NCT04699994: 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
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Esophageal Squamous Cell Carcinoma
Lead sponsor: Keio University
Sponsor class: OTHER
First posted: 2021-01-07
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Histological response rate (Grade 2 or 3 in Japanese Classification of Esophageal Cancer, 11th Edition)
timeFrame: 2.5 years
Secondary outcomes:
measure: Response rate
timeFrame: 2.5 years
measure: Histological complete response rate
timeFrame: 2.5 years
measure: Treatment completion rate
timeFrame: 2.5 years
measure: Curative resection rate
timeFrame: 2.5 years
measure: Recurrence free survival
timeFrame: 4.5 years
measure: Overall survival
timeFrame: 4.5 years
measure: Incidence rate of adverse event during FLOT
timeFrame: 2.5 years
measure: Perioperative complication rate
timeFrame: 2.5 years
measure: Late phase complication rate
timeFrame: 4.5 years
measure: Incidence rate of severe adverse event
timeFrame: 2.5 years
measure: Incidence rate of all adverse event
timeFrame: 4.5 years
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Keio University Hospital
Study officials:
References: