JPRN-jRCTs031200094
Active, not 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
Kawakubo Hirofumi0 sites60 target enrollmentAugust 24, 2020
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Kawakubo Hirofumi
- Enrollment
- 60
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
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
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
Outcomes
Primary Outcomes
Not specified
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