PIT-2
- Conditions
- Primary lung cancerMediastinal lymph node metastasis, Squamous cell carcinoma
- Registration Number
- JPRN-jRCTs031180403
- Lead Sponsor
- Suzuki Kenji
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 45
(1) Histologically or cytologically proven squamous cel carcinoma of the lung, diagnosed using specimen material
(2) Stage IIIA- pathologically proven N2 disease
(3) Without previously treatment for lung cancer
(4) 20 years or more , 75 years or less
(5) ECOG PS 0-1
(6) Expected FEV 1.0 > 800ml after lung resection , SpO2 (Room air) >95%
(7) Adequate organ function
(8) Written informed consent
(1) Uncontrollable systemic disease (hyper tension, diabetes mellitus etc.)
(2) Under administration of flucytosine
(3) History of active infection
(4) Hepatitis Bs antigen positive
(5) History of severe heart disease
(6) Traumatic fracture of un recovery
(7) Severe diarrhea
(8) Severe drug allergy
(9) Investigational new drug or the unapproved drug is administered
(10) Interstitial pneumonia or pulmonary fibrosis detectable on chest CT
(11) History of active double cancer
(12) History of pregnancy or lactation
(13) Any other medical condition that makes the patient unsuitable for inclusion in the study according to the opinion of the investigator
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 2-year progression-free survival
- Secondary Outcome Measures
Name Time Method - 5-year progression-free survival<br>- 2-year and 5-year overall survival <br>- Completion rate of the protocol treatment<br>- Complete resection rate<br>- Radiological response rate<br>- Down staging rate<br>- Safety <br>- Pathological response (Ef)<br>- Tumor markers (CEA/CYFRA)<br>- SUVmax on FDG-PET scan