UMIN-CTR Clinical Trial

Basic information
Public title	Phase II Study of induction Carboplatin+Paclitaxel+Bevacizumab combination therapy for stage III Non-Small-Cell Lung Cancer (NSCLC)
Acronym	Phase II Study of induction Carboplatin+Paclitaxel+Bevacizumab combination therapy for stage III NSCLC (TCOG1002)
Scientific Title	Phase II Study of induction Carboplatin+Paclitaxel+Bevacizumab combination therapy for stage III Non-Small-Cell Lung Cancer (NSCLC)
Scientific Title:Acronym	Phase II Study of induction Carboplatin+Paclitaxel+Bevacizumab combination therapy for stage III NSCLC (TCOG1002)
Region	Japan

Condition
Condition	Non-Squamous Non-Small-Cell Lung Cancer
Classification by specialty	Pneumology Chest surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy of preoperative Carboplatin+Paclitaxel+Bevacizumab combination therapy followed by surgery for stage III Non-Squamous Non-Small-Cell Lung Cancer
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	ORR
Key secondary outcomes	2 year survival rate Complete resection rate RFS DFS PFS pRR Safety

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 Maneuver
Interventions/Control_1	CBDCA AUC=6(day1)+ Paclitaxel 200mg/m2(day1)+ Bevacizumab 15mg/kg (day1) q3weeks 2cycles CBDCA AUC=6(day1)+ Paclitaxel 200mg/m2(day1)+ q3weeks 1cycles Surgical operation is performed over 5 weeks after chemotherapy
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	75 years-old >
Gender	Male and Female
Key inclusion criteria	1)Histologically or cytologically confirmed non-squamous non-small cell lung cancer(NSCLC) 2)Patients with stage IIIa or IIIb(UICC-7)However,"T3N1"is excluded 3)Patients with measurable lesion(RECIST ver.1.1) 4)Age:20-74years old 5)ECOG PS 0-1 6)Patients without previous treatment for NSCLC 7)If the patient underwent therapy, there should be the following interval between the therapy and the registration -Open biopsy,Treatment of injury->2 weeks -Aspiration biopsy,->1 week 8)Sufficient organ function neutro>=1500/mm3 Plt >=100000/mm3 Hb >=9.0g/dl T-bil <= 1.5mg/dl GOT/GPT <= 99IU/L Cr >= 1.5mg/dl SpO2 >= 95% or PaO2>=70mmHG FEV1.0 >=1.0L PT-INR<=1.5 Proteinuria <=1+ 9)Patients are expected to live over 3 months 10)Written IC
Key exclusion criteria	1)History of active double cancer within 5 years 2)Overt infection 3)History of hemoptysis 4)With great vessel invasion 5)Cavity in tumor 6)Receiving anticoagulant drug(except Aspirin within 324mg/day) 7)Uncontrollable Gastrointestinal ulceration 8)Current or previous(within the last 1 year)history of GI perforation 9)Severe cardiac disease 10)History of Arterial thromboembolism within 1year 11)Interstitial pneumonia or pulmonary fibrosis detectable on X-ray 12)Peripheral neuropathy > Grade2 13)Major surgical procedure 14)With a history of drug sensitivity 15)History of pregnancy or lactation 16)No intention to practice birth control 17)Patients whose participation in the trial is judged to be inappropriate by the attending doctor
Target sample size	25

Research contact person
Last name of lead principal investigator	1st name Middle name Last name Norihiko Ikeda
Organization	Tokyo medical university
Division name	First department of surgery
Zip code
Address	6-1-1 Shinjuku Shinjuku-ku Tokyo, Japan
TEL	03-3342-6111
Email	tcog-lc@tcog.jp

Public contact
1st name of contact person	1st name Middle name Last name TCOG Lung Cancer affairs office
Organization	The Tokyo Cooperative Oncology Group
Division name	Clinical Study Promotion Agency
Zip code
Address	Toa BLDG. 4F 2-1-18 Hamamatsu-cho Minato-ku Tokyo, Japan
TEL	03-5401-5020
Homepage URL
Email	tcog-lc@tcog.jp

Sponsor
Institute	The Tokyo Cooperative Oncology Group
Institute
Department

Funding Source
Organization	The Tokyo Cooperative Oncology Group
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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	東京医科大学 癌研有明病院 北里大学 熊本大学 千葉県がんセンター 千葉大学

Other administrative information
Date of disclosure of the study information	2010 Year 10 Month 05 Day

Related information
URL releasing protocol
Publication of results	Partially published

Result
URL related to results and publications	http://abstracts.asco.org/144/AbstView_144_126651.html
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2010 Year 09 Month 17 Day
Date of IRB	2010 Year 08 Month 31 Day
Anticipated trial start date	2011 Year 03 Month 01 Day
Last follow-up date	2014 Year 05 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2018 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date	2010 Year 10 Month 05 Day
Last modified on	2019 Year 04 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005012