Non-Squamouns Non-small-cell-lung-cancer
Conditions
Interventions
PEM 500 mg/m2 as preoperative therapy to aid Day1 under folic acid and VB12, administered, BEV 15mg/kg CBDCA AUC5, 3 weeks*2 cycles. However, the third course, two-drug combination of CBDCA and PEM.
Sponsors
Kansai Medical University Hirakata Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: >preoperative therapy (1)histologically or cytologically confirmed non-squamous non-small cell lung cancer(NSCLC) (2)Stage IB/II/IIIA(UICC-7) NSCLC (3)Age:20 years (4)ECOG performance status of 0 or 1 (5)Normal organ function WBC>4,000/mm-3 neutro > 2,000/mm-3, Plt > 100,000/mm-3, Hb > 9.5 g/dL-1, AST(GOT), ALT(GPT)< 3.0x upper normal limit, T-Bil< 1.5x upper normal limit, creatinine clearance > 60 ml/min (6)Written informed consent >postoperative therapy (1)Non-PD after 3 cycles of induction Chemotherapy (2)Restore organ function (a)WBC > 4,000/mm-3 (b)neutro > 2,000/mm-3, Plt > 100,000/mm-3, Hb > 9.5 g/dL-1, AST(GOT), ALT(GPT)< 3.0x upper normal limit, T-Bil< 1.5x upper normal limit, creatinine clearance > 60 ml/min
Exclusion criteria
Exclusion criteria: >preoperative therapy (1) severe comorbit disease (2) history of hemoptysis, coagulation disorder and thrombosis or receive oral/i.v. hemostatic drug (3) With a clinical bleeding tendency (4) tumor cavitation and invasion to the major vessel (5) Patients of Untreated fracture (Such as compression fractures due to osteoporosis are excluded) or High degree of wound (7)Patients of the merger of infections requiring intravenous administration of anti-viral agents or anti-fungal agents,antibiotics (8) Patients with therapeutic anticoagulopathy (including Aspirin over 325mg/day) (9) Patients with uncontrollable gastrointestinal ulceration (10) Patients with current or previous (within one year) history of gastrointestinal perforation (11) Patients with Symptomatic congestive heart failure,Unstable angina,Arrhythmia with treatment. Patients With a history of myocardial infarction within one year prior to registration. (12)In patients with persistent diarrhea. (There is a watery stool more than three times a day at the time of registration) (13) Patients with previous histories of drug allergy (14)history of drug induced interstitial pneumonia (15)regnant or lactating women or those who declined contraception (16)those judged to be not suitable by the attending physician >postoperative therapy (1) It is found that you have been registered in violation of the selection criteria or exclusion criteria (2) Apparent worsening of the disease due to cancer was observed
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Treatment completion rate of the protocol Treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Response Rate Disease Free Survival Overall Survival Rate of Serious adverse events | — |
Countries
Japan
Contacts
Public ContactTAKASHI YOKOI
Kansai Medical University Hirakata Hospital respiratory medicine
Outcome results
None listed