PIT-1
- Conditions
- Primary lung cancerMediastinal lymph node metastasis
- Registration Number
- JPRN-jRCTs031180402
- Lead Sponsor
- Suzuki Kenji
- Brief Summary
Although not significant, the 2-year progression-free survival rate was higher in the thoracic radiotherapy arm than in the bevacizumab arm. Fatal surgical complications were only observed in the bevacizumab arm. Therefore, pemetrexed-cisplatin with concurrent thoracic radiotherapy was chosen as the investigational induction treatment strategy for future phase III trials.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 88
(1) Histologically or cytologically proven non-squamous non-small cell lung cancer, diagnosed using specimen material obtained from primary tumor or metastastatic lymph node
(2) Stage IIIA- pathologically proven N2 disease
(3) Without previously treatment for lung cancer
(4) 20years 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) Current history of hemosputum or hemoptysis
(3) Evidence of bleeding diathesis or coagulopathy
(4) Cavity in lung tumor or great vessel involvement
(5) Current or previous (within the last 1 year) history of cerebrovascular disease
(6) Traumatic fracture of un recovery
(7) History of active infection
(8) hepatitis B surface antigen positive
(9) Therapeutic anticoagulation; regular use of aspirin (>325 mg/day)
(10) Severe GI disease
(11) Current or previous (within the last 1 year) history of GI perforation or diverticultis
(12) History of severe heart disease
(13) Severe diarrhea
(14) Severe drug allergy
(15) Investigational new drug or the unapproved drug is administered
(16) Interstitial pneumonia or pulmonary fibrosis detectable on chest Xp
(17) History of active double cancer
(18) History of pregnancy or lactation
(19) 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 (1)5-year progression-free survival <br>(2)2-year and 5-year overall survival <br>(3)Completion rate of the protocol treatment<br>(4)Complete resection rate<br>(5)Radiological response rate <br>(6)Down staging rate<br>(7)Safety <br>(8)Pathological response (Ef)<br>(9)Tumor markers (CEA/CYFRA)<br>(10)SUVmax on FDG-PET scan