UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	PhaseII Study of Neoadjuvant and adjuvant Chemotherapy with Pemetrexed/Carboplatin/Bevacizumab in patients with non-squamouns non Small-cell lung cancer
Title of the study (Brief title)	PhaseII Study of Neoadjuvant and adjuvant Chemotherapy with Pemetrexed/Carboplatin/Bevacizumab in patients with non-squamouns non Small-cell lung cancer
Region	Japan

Condition
Condition	Non-Squamouns Non-small-cell-lung-cancer
Classification by specialty	Pneumology Hematology and clinical oncology Chest surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	PhaseII Study of Neoadjuvant and adjuvant Chemotherapy with Pemetrexed/Carboplatin/Bevacizumab in patients with non-squamouns non Small-cell lung cancer
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	Treatment completion rate of the protocol Treatment
Key secondary outcomes	Response Rate Disease Free Survival Overall Survival Rate of Serious adverse events

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	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. For patients over SD is carried out every two week course 3 PEM 500 mg/m2 as adjuvant therapy, the CBDCA AUC5 at preoperative therapy.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key 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
Key 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
Target sample size	35

Research contact person
Name of lead principal investigator	TAKASHI YOKOI
Organization	Kansai Medical University Hirakata Hospital
Division name	respiratory medicine
Address	2-3-1, Shinmachi, Hirakata-city, OSAKA
TEL	072-804-0101
Email	yokoit@hirakata.kmu.ac.jp

Public contact
Name of contact person	TAKASHI YOKOI
Organization	Kansai Medical University Hirakata Hospital
Division name	respiratory medicine
Address	2-3-1, Shinmachi, Hirakata-city, OSAKA
TEL	0728040806
Homepage URL
Email	yokoit@hirakata.kmu.ac.jp

Sponsor
Institute	Kansai Medical University Hirakata Hospital
Institute
Department

Funding Source
Organization	Kansai Medical University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	関西医科大学附属枚方病院

Other administrative information
Date of disclosure of the study information	2012 Year 10 Month 03 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2012 Year 10 Month 03 Day
Anticipated trial start date	2012 Year 10 Month 03 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2012 Year 10 Month 03 Day
Last modified on	2018 Year 04 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000010598