JPRN-jRCTs031180202Active, not recruitingPhase 3
JCOG1109: A randomized controlled phase III comparing CF versus DCF versus CF-RT as neoadjuvant treatment for locally advanced esophageal cancer - NExT study
Kato Ken0 sites600 target enrollmentStarted: March 7, 2019Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 3
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 600
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- >= 20age old to <= 75age old (—)
- Sex
- All
Inclusion Criteria
- •1) Histologically proven squamous cell carcinoma, adenosquamous carcinoma, or basaloid cell carcinoma by endoscopic biopsy from esophageal primary tumor
- •2) All lesion located in the thoracic esophagus (the 7th edition of the UICC TNM classification)
- •3) Clinical stage IB, II, III (excluding T4) based on the 7th edition of the UICC TNM classification
- •4) Aged 20 to 75 years old
- •5) ECOG performance status of 0 or 1
- •6) Measurable lesions not required
- •7) No prior therapy against esophageal cancer except for the following cases
- •a) Complete resection by EMR/ESD (diagnosed as pT1a-EP (M1) or pT1a-LPM (M2) tumors)
- •b) Complete resection by EMR/ESD (diagnosed as pT1a-MM (M3) tumor without lymphovascular invasion)
- •8) No prior chemotherapy, radiotherapy or hormonal therapy against any cancers except for hormonal therapy for prostate cancer with more than 5 years of disease-free interval
- •9) Adequate organ functions
- •10) R0 esophagectomy is judged as possible by open (or laparoscopic) thoracotomy and laparotomy
- •11) Written informed consent
Exclusion Criteria
- •1) Simultaneous or metachronous (within 5 years) double cancers, except for intramucosal tumor curatively resected by local therapy
- •2) Active infection requiring systemic therapy
- •3) Positive HBs antigen, HCV antibody or HIV antibody
- •4) Pregnant or lactating women or women of childbearing potential
- •5) Psychiatric disease or symptom
- •6) Patients requiring systemic steroids medication (internal or intravenous use)
- •7) Requiring continuous administration of flucytosine, phenytoin or warfarin potassium
- •8) Iodine hypersensitivity
- •9) Hypersensitivity for docetaxel, cisplatin or polysorbate 80 containing drug
- •10) Diabetes mellitus with HbA1c of 6.5% (value of Japan Diabetes Society (JDS)), 6.9% (value of National Glycohemoglobin Standardization Program (NGSP))or higher
- •11) Severe emphysema or pulmonary fibrosis detected by lung function test or CT
- •12) Poorly controlled hypertension
- •13) Unstable angina (onset or worse heart attack of angina within 3 weeks), or with a history of myocardial infarction within 6 months.
Investigators
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